Study Of Adults And Adolescents With Vasomotor Rhinitis

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00117325
• Collaborator: (none)
• Enrollment: 352
• Locations: 53
• Arm: 1
• Actual Duration (Months): 7
• Patients Per Site: 6.6
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

The primary objective of this study is to compare the efficacy and safety of GW685698X 100mcg once daily (QD) aqueous nasal spray with vehicle placebo nasal spray in adult and adolescent subjects (12 years of age and older) with vasomotor rhinitis (VMR).

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Vasomotor	Drug: GW685698X	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 352 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Primary Purpose: Treatment
• Official Title: A 4 Week Randomized, Double Blind, Placebo Controlled Study of GW685698X Aq Nasal Spray 100mcg QD in Adults and Adolescents With Vasomotor Rhinitis
• Actual Study Start Date: Jul 11, 2005
• Actual Primary Completion Date: Feb 9, 2006
• Actual Study Completion Date: Feb 9, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: GW685698X GW685698X	Drug: GW685698X; Aqueous Nasal Spray 100mcg

Outcome Measures

Primary Outcome Measures

1. Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS) [Baseline (4 days prior to randomization [Day 1]) and up to Week 4]

   The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Secondary Outcome Measures

1. Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS) [Baseline (4 days prior to randomization [Day 1]) and up to Week 4]

   The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from baseline was calculated as endpoint value minus the baseline value. Baseline visit was 4 days prior to randomization (Day 1).

2. Number of Participants With Overall Evaluation of Response to Therapy [Up to 4 weeks]

   The overall evaluation of Response to Therapy was based on a 7-point categorical scale where the participants rated their perception of the change or lack of change in their VMR (Vasomotor rhinitis) symptoms at the end of the study. The 7 categories were: 1=significantly improved, 2=moderately improved, 3= mildly improved, 4= no change, 5= mildly worse, 6= moderately worse, and 7= significantly worse.

3. Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS [Baseline (4 days prior to randomization [Day 1]) and up to Week 4]

   The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. Change from Baseline was calculated as post randomization value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

4. Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS [Baseline (4 days prior to randomization [Day 1]) and up to Week 4]

   The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the PM (PM rTNSS). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

5. Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS [Baseline (4 days prior to randomization [Day 1]) and up to Week 4]

   The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments.The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

6. Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS [Baseline (4 days prior to randomization [Day 1]) and up to Week 4]

   The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

7. Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip [Baseline (4 days prior to randomization [Day 1]) and up to Week 4]

   The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The daily reflective nasal symptom scores was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

8. Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip [Baseline (4 days prior to randomization [Day 1]) and up to Week 4]

   The AM, pre-dose, instantaneous nasal symptom score is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

9. Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip [Baseline (4 days prior to randomization [Day 1]) and up to Week 4]

   The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

10. Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip [Baseline (4 days prior to randomization [Day 1]) and up to Week 4]

    The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and was performed in the PM (PM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

11. Mean Scores Changes From Baseline as a Function of Time [Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days]

    The onset of treatment effect was assessed by the mean change from Baseline in AM iTNSS (Days 1 to 28), the mean change from Baseline in daily rTNSS (Days 1 to 28), and mean change from Baseline in AM rTNSS and PM rTNSS. The time to maximum effect was also evaluated by the mean change from Baseline in daily rTNSS for Days 1 to 28. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Must be outpatients.

• Diagnosis of VMR.

• Literate in English or native language.

Exclusion criteria:

• Significant concomitant medical condition.

• Use corticosteroids or other allergy medications during the study.

• Used tobacco products within the past year.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Beverly Hills	California	United States	90212
2	GSK Investigational Site	Huntington Beach	California	United States	92647
3	GSK Investigational Site	Mission Viejo	California	United States	92691
4	GSK Investigational Site	San Diego	California	United States	92120
5	GSK Investigational Site	San Diego	California	United States	92123
6	GSK Investigational Site	Santa Barbara	California	United States	93105
7	GSK Investigational Site	Colorado Springs	Colorado	United States	80907
8	GSK Investigational Site	Englewood	Colorado	United States	80112
9	GSK Investigational Site	Fort Collins	Colorado	United States	80526
10	GSK Investigational Site	Woodstock	Georgia	United States	30188
11	GSK Investigational Site	Chicago	Illinois	United States	60637
12	GSK Investigational Site	Evansville	Indiana	United States	47713
13	GSK Investigational Site	Louisville	Kentucky	United States	40207
14	GSK Investigational Site	Covington	Louisiana	United States	70433
15	GSK Investigational Site	Shreveport	Louisiana	United States	71104
16	GSK Investigational Site	Bangor	Maine	United States	04401
17	GSK Investigational Site	Baltimore	Maryland	United States	21236
18	GSK Investigational Site	Rockville	Maryland	United States	20850
19	GSK Investigational Site	Novi	Michigan	United States	48375
20	GSK Investigational Site	Ypsilanti	Michigan	United States	48197
21	GSK Investigational Site	Minneapolis	Minnesota	United States	55402
22	GSK Investigational Site	Mount Laurel	New Jersey	United States	08054
23	GSK Investigational Site	Liverpool	New York	United States	13088
24	GSK Investigational Site	Rochester	New York	United States	14618
25	GSK Investigational Site	Canton	Ohio	United States	44718
26	GSK Investigational Site	Cincinnati	Ohio	United States	45231
27	GSK Investigational Site	North Olmsted	Ohio	United States	44070
28	GSK Investigational Site	Lake Oswego	Oregon	United States	97035
29	GSK Investigational Site	Portland	Oregon	United States	97213
30	GSK Investigational Site	Easton	Pennsylvania	United States	18042
31	GSK Investigational Site	Palmyra	Pennsylvania	United States	17078
32	GSK Investigational Site	Pittsburgh	Pennsylvania	United States	15213
33	GSK Investigational Site	Upland	Pennsylvania	United States	19013
34	GSK Investigational Site	Charleston	South Carolina	United States	29407
35	GSK Investigational Site	Orangeburg	South Carolina	United States	29118
36	GSK Investigational Site	Germantown	Tennessee	United States	38138
37	GSK Investigational Site	Knoxville	Tennessee	United States	37922
38	GSK Investigational Site	Salt Lake City	Utah	United States	84102
39	GSK Investigational Site	Kelowna	British Columbia	Canada	V1Y 9L8
40	GSK Investigational Site	Hamilton	Ontario	Canada	L8N 3Z5
41	GSK Investigational Site	Québec		Canada	G1V 4M6
42	GSK Investigational Site	Litomerice		Czechia	412 01
43	GSK Investigational Site	Olomouc		Czechia	775 25
44	GSK Investigational Site	Tabor		Czechia	390 19
45	GSK Investigational Site	Kassel	Hessen	Germany	34117
46	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern	Germany	19055
47	GSK Investigational Site	Hannover	Niedersachsen	Germany	30159
48	GSK Investigational Site	Geesthacht	Schleswig-Holstein	Germany	21502
49	GSK Investigational Site	Hamburg		Germany	20249
50	GSK Investigational Site	Larvik		Norway	N-3256
51	GSK Investigational Site	Nesttun		Norway	N-5227
52	GSK Investigational Site	Bucuresti		Romania
53	GSK Investigational Site	Deva		Romania	2700

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT00117325
• Other Study ID Numbers: FFR30006
• First Posted: Jul 6, 2005
• Last Update Posted: Mar 13, 2018
• Last Verified: Aug 1, 2017

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by GlaxoSmithKline: Vasomotor Rhinitis; VMR; nonallergic rhinitis; GW685698X
• Additional relevant MeSH terms: Rhinitis; Rhinitis, Vasomotor

Study Results

Participant Flow

Recruitment Details	The actual dose delivered from the product was 27.5 micrograms (µg) /actuation, which is therefore proposed as the label claim rather than 25 µg/actuation. Based on this spray content assessment, the dose examined in this study was actually 110 µg rather than the 100 µg dose indicated in the protocol.
Pre-assignment Detail	Out of 901 participants screened, 549 participants were screen failures and hence were not randomized into the study. Out of 901 participants screened, 352 participants were randomized from 11 July 2005 to 16 January 2006.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 microgram (mcg) administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received Fluticasone Furoate (GW 685698X) aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Period Title: Overall Study
STARTED	173	179
COMPLETED	160	167
NOT COMPLETED	13	12

Baseline Characteristics

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD	Total
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Total of all reporting groups
Overall Participants	173	179	352
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	45.0 (14.66)	46.6 (16.77)	45.8 (15.77)
Sex: Female, Male (Count of Participants)
Female	122 70.5%	125 69.8%	247 70.2%
Male	51 29.5%	54 30.2%	105 29.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 0.6%	1 0.3%
Asian	1 0.6%	1 0.6%	2 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	6 3.5%	4 2.2%	10 2.8%
White	163 94.2%	169 94.4%	332 94.3%
More than one race	3 1.7%	4 2.2%	7 2%
Unknown or Not Reported	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline Over the Entire Treatment Period in Daily Reflective Total Nasal Symptom Score (rTNSS)
Description	The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom scores for rhinorrhea, nasal congestion and postnasal drip where each symptom was scored on a scale of 0 (no symptoms) to 3 (severe symptoms).. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame	Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Outcome Measure Data

Analysis Population Description

Due to irregularities found during a compliance audit, a reduced intent-to-treat (RITT) population was defined which excludes two participants from one of the investigative sites.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	170	176
Least Squares Mean (Standard Error) [Score on scale]	-1.71 (0.16)	-2.05 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.050
	Comments
	Method	ANCOVA
	Comments	Analysis of covariance (ANCOVA) method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.335
	Confidence Interval	(2-Sided) 95%; -0.67 to 0.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Mean Change From Baseline Over the Entire Treatment Period in Morning (AM), Pre-dose, Instantaneous Total Nasal Symptom Scores (iTNSS)
Description	The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from baseline was calculated as endpoint value minus the baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame	Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Outcome Measure Data

Analysis Population Description

Reduced ITT Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	170	176
Least Squares Mean (Standard Error) [Score on scale]	-1.48 (0.16)	-1.87 (0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments	Week 1-4
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.393
	Confidence Interval	(2-Sided) 95%; -0.74 to -0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Participants With Overall Evaluation of Response to Therapy
Description	The overall evaluation of Response to Therapy was based on a 7-point categorical scale where the participants rated their perception of the change or lack of change in their VMR (Vasomotor rhinitis) symptoms at the end of the study. The 7 categories were: 1=significantly improved, 2=moderately improved, 3= mildly improved, 4= no change, 5= mildly worse, 6= moderately worse, and 7= significantly worse.
Time Frame	Up to 4 weeks

Outcome Measure Data

Analysis Population Description

RITT population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	168	176
Significantly Improved	26 15%	33 18.4%
Moderately Improved	37 21.4%	40 22.3%
Mildly Improved	45 26%	47 26.3%
No Change	52 30.1%	50 27.9%
Mildly Worse	1 0.6%	3 1.7%
Moderately Worse	4 2.3%	1 0.6%
Significantly Worse	3 1.7%	2 1.1%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.184
	Comments
	Method	Regression, Logistic
	Comments	logistic regression adjusting for age, gender, investigator, and treatment.
Other Statistical Analysis		Effectiveness of study medication for relieving non-allergic rhinitis symptoms over the entire treatment period (Total response) was analyzed.

4. Secondary Outcome

Title	Mean Change From Baseline Over the Entire Treatment Period in AM Pre-dose rTNSS
Description	The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). . The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. Change from Baseline was calculated as post randomization value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame	Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Outcome Measure Data

Analysis Population Description

RITT population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	170	176
Least Squares Mean (Standard Error) [Score on scale]	-1.69 (0.16)	-2.04 (0.16)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.051
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.348
	Confidence Interval	(2-Sided) 95%; -0.70 to 0.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Mean Change From Baseline Over the Entire Treatment Period in Evening (PM) rTNSS
Description	The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in the PM (PM rTNSS). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame	Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Outcome Measure Data

Analysis Population Description

RITT Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	172	178
Least Squares Mean (Standard Error) [Score on scale]	-1.77 (0.16)	-2.07 (0.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD up to Week 4 analysis
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.076
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.304
	Confidence Interval	(2-Sided) 95%; -0.64 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Mean Percent Change From Baseline Over the Entire Treatment Period in Daily rTNSS
Description	The daily rTNSS was the average of the AM (morning) and PM (before bed time) rTNSS assessments.The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame	Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Outcome Measure Data

Analysis Population Description

RITT Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	170	176
Least Squares Mean (Standard Error) [Percent change in score]	-26.14 (2.45)	-30.65 (2.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.093
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-4.510
	Confidence Interval	(2-Sided) 95%; -9.77 to 0.75
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Mean Percent Change From Baseline Over the Entire Treatment Period in AM, Pre-dose iTNSS
Description	The AM, pre-dose, iTNSS is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame	Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Outcome Measure Data

Analysis Population Description

RITT Population. Only those participants with data available at the indicated time points were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	170	176
Least Squares Mean (Standard Error) [Percent change in score]	-21.09 (2.54)	-27.46 (2.50)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD Week 1-4 analysis.
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.023
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline iTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-6.372
	Confidence Interval	(2-Sided) 95%; -11.8 to -0.90
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Mean Change From Baseline Over the Entire Treatment Period in Individual Daily, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Post-nasal Drip
Description	The TNSS was the sum of the individual symptom scores for rhinorrhoea, nasal congestion and post-nasal drip which was scored on a scale of 0-3. The severity of symptoms was defined as 0: none-symptom was not present, 1: mild-sign/symptom was clearly present but minimal awareness; easily tolerated, 2: moderate-definite awareness of sign/symptom that was bothersome but tolerable, 3: severe (sign/symptom was hard to tolerate; causes interference with activities of daily living and/or sleeping. The daily reflective nasal symptom scores was the average of the AM (morning) and PM (before bed time) rTNSS assessments. Each rTNSS assessment comprised the sum of the three nasal symptom. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame	Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Outcome Measure Data

Analysis Population Description

RITT Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	172	178
Rhinorrhea	-0.50 (0.06)	-0.62 (0.06)
Nasal Congestion	-0.68 (0.06)	-0.81 (0.06)
Post-nasal Drip	-0.51 (0.06)	-0.61 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.061
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.118
	Confidence Interval	(2-Sided) 95%; -0.24 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for Nasal Congestion
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.061
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.124
	Confidence Interval	(2-Sided) 95%; -0.25 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.138
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.095
	Confidence Interval	(2-Sided) 95%; -0.22 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Pre-dose, Instantaneous, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
Description	The AM, pre-dose, instantaneous nasal symptom score is the sum of the 3 individual nasal symptom score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame	Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Outcome Measure Data

Analysis Population Description

RITT Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	172	178
Rhinorrhea	-0.44 (0.06)	-0.56 (0.06)
Nasal congestion	-0.54 (0.06)	-0.70 (0.06)
Post-nasal drip	-0.48 (0.06)	-0.60 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.087
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.113
	Confidence Interval	(2-Sided) 95%; -0.24 to 0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.015
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.164
	Confidence Interval	(2-Sided) 95%; -0.30 to -0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.106
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.112
	Confidence Interval	(2-Sided) 95%; -0.25 to 0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Mean Change From Baseline Over the Entire Treatment Period in Individual AM, Reflective Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
Description	The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and is performed in the AM (AM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame	Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Outcome Measure Data

Analysis Population Description

RITT Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate 110mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	172	178
Rhinorrhea	-0.48 (0.06)	-0.61 (0.06)
Nasal congestion	-0.65 (0.06)	-0.78 (0.06)
Post-nasal drip	-0.55 (0.06)	-0.64 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rhinorrhea
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.048
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.132
	Confidence Interval	(2-Sided) 95%; -0.26 to -0.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for Nasal congestion
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.076
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.124
	Confidence Interval	(2-Sided) 95%; -0.26 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg for post-nasal drip
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.164
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.093
	Confidence Interval	(2-Sided) 95%; -0.22 to 0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Mean Change From Baseline Over the Entire Treatment Period in Individual PM, Reflective, Nasal Symptom Scores for Rhinorrhea, Nasal Congestion and Postnasal Drip
Description	The reflective nasal symptom score is a rating of the severity of symptoms over the previous 12 hours and was performed in the PM (PM rTNSS). Score assessments for rhinorrhea, nasal congestion and postnasal drip performed at the moment immediately prior to taking their dose where each symptom was scored on a scale of 0 to 3 (0= no symptoms, 3= severe symptoms). Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame	Baseline (4 days prior to randomization [Day 1]) and up to Week 4

Outcome Measure Data

Analysis Population Description

RITT Population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	172	178
Rhinorrhea	-0.53 (0.06)	-0.59 (0.06)
Nasal congestion	-0.73 (0.06)	-0.84 (0.06)
Post-nasal drip	-0.49 (0.06)	-0.59 (0.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for Rhinorrhea
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.136
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.096
	Confidence Interval	(2-Sided) 95%; -0.22 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for nasal congestion
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.100
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.111
	Confidence Interval	() 95%; -0.24 to 0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for post-nasal drip
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.100
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.111
	Confidence Interval	(2-Sided) 95%; -0.24 to 0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Mean Scores Changes From Baseline as a Function of Time
Description	The onset of treatment effect was assessed by the mean change from Baseline in AM iTNSS (Days 1 to 28), the mean change from Baseline in daily rTNSS (Days 1 to 28), and mean change from Baseline in AM rTNSS and PM rTNSS. The time to maximum effect was also evaluated by the mean change from Baseline in daily rTNSS for Days 1 to 28. Change from Baseline was calculated as any post-Baseline value minus the Baseline value. Baseline visit was 4 days prior to randomization (Day 1).
Time Frame	Baseline (4 days prior to randomization [Day 1]) and Daily for 28 days

Outcome Measure Data

Analysis Population Description

RITT population. Only those participants with data available at the specified time points were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate 110 mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.	Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
Measure Participants	172	178
AM iTNSS Day 1	-0.47 (0.16)	-0.92 (0.16)
AM iTNSS Day 2	-0.69 (0.17)	-1.01 (0.17)
AM iTNSS Day 3	-0.75 (0.18)	-1.14 (0.18)
AM iTNSS Day 4	-0.96 (0.18)	-1.22 (0.18)
AM iTNSS Day 5	-1.15 (0.20)	-1.45 (0.19)
AM iTNSS Day 6	-1.01 (0.20)	-1.59 (0.19)
AM iTNSS Day 7	-1.17 (0.20)	-1.55 (0.19)
AM iTNSS Day 8	-1.38 (0.20)	-1.61 (0.20)
AM iTNSS Day 9	-1.47 (0.20)	-1.66 (0.20)
AM iTNSS Day 10	-1.31 (0.21)	-1.78 (0.21)
AM iTNSS Day 11	-1.48 (0.22)	-1.66 (0.21)
AMiTNSS Day 12	-1.52 (0.22)	-1.86 (0.21)
AM iTNSS Day 13	-1.48 (0.22)	-1.83 (0.21)
AM iTNSS Day 14	-1.72 (0.21)	-1.95 (0.20)
AM iTNSS Day 15	-1.54 (0.21)	-1.92 (0.21)
AM iTNSS Day 16	-1.56 (0.21)	-1.99 (0.21)
AM iTNSS Day 17	-1.64 (0.22)	-2.20 (0.22)
AM iTNSS Day 18	-1.75 (0.21)	-2.21 (0.21)
AM iTNSS Day 19	-1.70 (0.21)	-2.33 (0.21)
AM iTNSS Day 20	-1.89 (0.22)	-2.11 (0.21)
AM iTNSS Day 21	-1.97 (0.22)	-2.26 (0.22)
AM iTNSS Day 22	-1.73 (0.22)	-2.32 (0.22)
AM iTNSS Day 23	-1.80 (0.23)	-2.27 (0.22)
AM iTNSS Day 24	-1.93 (0.23)	-2.40 (0.22)
AM iTNSS Day 25	-1.93 (0.22)	-2.36 (0.22)
AM iTNSS Day 26	-2.10 (0.23)	-2.68 (0.22)
AM iTNSS Day 27	-2.01 (0.23)	-2.49 (0.22)
AM iTNSS Day 28	-1.96 (0.28)	-2.62 (0.26)
rTNSS Day 1	-0.71 (0.16)	-0.93 (0.15)
rTNSS Day 2	-0.91 (0.16)	-1.17 (0.16)
rTNSS Day 3	-1.07 (0.17)	-1.38 (0.16)
rTNSS Day 4	-1.15 (0.17)	-1.43 (0.16)
rTNSS Day 5	-1.22 (0.17)	-1.35 (0.17)
rTNSS Day 6	-1.21 (0.19)	-1.51 (0.18)
rTNSS Day 7	-1.37 (0.19)	-1.66 (0.18)
rTNSS Day 8	-1.58 (0.18)	-1.82 (0.18)
rTNSS Day 9	-1.55 (0.20)	-1.92 (0.19)
rTNSS Day 10	-1.60 (0.20)	-2.06 (0.19)
rTNSS Day 11	-1.65 (0.20)	-1.96 (0.20)
rTNSS Day 12	-1.81 (0.19)	-2.14 (0.19)
rTNSS Day 13	-1.87 (0.20)	-2.12 (0.20)
rTNSS Day 14	-1.83 (0.20)	-2.17 (0.20)
rTNSS Day 15	-1.70 (0.20)	-2.11 (0.20)
rTNSS Day 16	-1.82 (0.20)	-2.38 (0.20)
rTNSS Day 17	-1.94 (0.21)	-2.53 (0.20)
rTNSS Day 18	-2.21 (0.20)	-2.51 (0.20)
rTNSS Day 19	-1.99 (0.20)	-2.44 (0.20)
rTNSS Day 20	-2.16 (0.20)	-2.47 (0.20)
rTNSS Day 21	-2.12 (0.21)	-2.54 (0.20)
rTNSS Day 22	-2.01 (0.21)	-2.47 (0.21)
rTNSS Day 23	-1.99 (0.21)	-2.30 (0.20)
rTNSS Day 24	-2.12 (0.21)	-2.60 (0.20)
rTNSS Day 25	-2.28 (0.22)	-2.44 (0.21)
rTNSS Day 26	-2.25 (0.22)	-2.57 (0.21)
rTNSS Day 27	-2.23 (0.22)	-2.51 (0.21)
rTNSS Day 28	-1.93 (0.28)	-2.58 (0.26)
AM rTNSS Day 1	-0.70 (0.18)	-1.02 (0.17)
AM rTNSS Day 2	-0.97 (0.18)	-1.20 (0.17)
AM rTNSS Day 3	-1.12 (0.18)	-1.37 (0.18)
AM rTNSS Day 4	-1.11 (0.18)	-1.45 (0.18)
AM rTNSS Day 5	-1.33 (0.19)	-1.48 (0.18)
AM rTNSS Day 6	-1.30 (0.20)	-1.59 (0.20)
AM rTNSS Day 7	-1.28 (0.21)	-1.69 (0.20)
AM rTNSS Day 8	-1.74 (0.21)	-1.85 (0.20)
AM rTNSS Day 9	-1.73 (0.21)	-1.94 (0.21)
AM rTNSS Day 10	-1.65 (0.21)	-2.10 (0.20)
AM rTNSS Day 11	-1.66 (0.21)	-1.96 (0.20)
AM rTNSS Day 12	-1.82 (0.21)	-2.05 (0.20)
AM rTNSS Day 13	-1.87 (0.22)	-2.06 (0.21)
AM rTNSS Day 14	-1.84 (0.21)	-2.14 (0.20)
AM rTNSS Day 15	-1.67 (0.22)	-2.15 (0.21)
AM rTNSS Day 16	-1.75 (0.22)	-2.37 (0.21)
AM rTNSS Day 17	-2.12 (0.22)	-2.62 (0.22)
AM rTNSS Day 18	-2.22 (0.21)	-2.48 (0.21)
AM rTNSS Day 19	-1.83 (0.22)	-2.37 (0.21)
AM rTNSS Day 20	-2.18 (0.22)	-2.42 (0.22)
AM rTNSS Day 21	-2.07 (0.22)	-2.64 (0.22)
AM rTNSS Day 22	-2.02 (0.23)	-2.44 (0.22)
AM rTNSS Day 23	-1.96 (0.23)	-2.17 (0.22)
AM rTNSS Day 24	-2.03 (0.23)	-2.57 (0.22)
AM rTNSS Day 25	-2.22 (0.23)	-2.45 (0.22)
AM rTNSS Day 26	-2.19 (0.23)	-2.59 (0.23)
AM rTNSS Day 27	-2.23 (0.23)	-2.54 (0.23)
AM rTNSS Day 28	-1.82 (0.30)	-2.55 (0.27)
PM rTNSS Day 1	-0.88 (0.20)	-0.97 (0.19)
PM rTNSS Day 2	-0.91 (0.18)	-1.19 (0.17)
PM rTNSS Day 3	-1.10 (0.19)	-1.39 (0.19)
PM rTNSS Day 4	-1.17 (0.19)	-1.42 (0.19)
PM rTNSS Day 5	-1.06 (0.19)	-1.29 (0.18)
PM rTNSS Day 6	-1.13 (0.21)	-1.42 (0.20)
PM rTNSS Day 7	-1.48 (0.20)	-1.64 (0.20)
PM rTNSS Day 8	-1.34 (0.20)	-1.73 (0.19)
PM rTNSS Day 9	-1.49 (0.21)	-1.89 (0.20)
PM rTNSS Day 10	-1.58 (0.21)	-2.07 (0.21)
PM rTNSS Day 11	-1.62 (0.22)	-2.02 (0.22)
PM rTNSS Day 12	-1.86 (0.21)	-2.29 (0.21)
PM rTNSS Day 13	-1.91 (0.22)	-2.18 (0.21)
PM rTNSS Day 14	-1.85 (0.23)	-2.15 (0.22)
PM rTNSS Day 15	-1.78 (0.22)	-2.15 (0.21)
PM rTNSS Day 16	-1.84 (0.23)	-2.33 (0.22)
PM rTNSS Day 17	-1.81 (0.22)	-2.51 (0.22)
PM rTNSS Day 18	-2.22 (0.22)	-2.54 (0.23)
PM rTNSS Day 19	-2.23 (0.21)	-2.53 (0.21)
PM rTNSS Day 20	-2.17 (0.21)	-2.52 (0.20)
PM rTNSS Day 21	-2.19 (0.23)	-2.48 (0.22)
PM rTNSS Day 22	-2.03 (0.22)	-2.53 (0.22)
PM rTNSS Day 23	-2.06 (0.23)	-2.41 (0.22)
PM rTNSS Day 24	-2.25 (0.22)	-2.64 (0.21)
PM rTNSS Day 25	-2.39 (0.23)	-2.42 (0.22)
PM rTNSS Day 26	-2.31 (0.23)	-2.54 (0.22)
PM rTNSS Day 27	-2.25 (0.23)	-2.54 (0.22)
PM rTNSS Day 28	-2.07 (0.30)	-2.68 (0.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.450
	Confidence Interval	(2-Sided) 95%; -0.80 to -0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 2
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.089
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.325
	Confidence Interval	(2-Sided) 95%; -0.70 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 3
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.052
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.393
	Confidence Interval	(2-Sided) 95%; -0.79 to 0.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.187
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.262
	Confidence Interval	(2-Sided) 95%; -0.65 to 0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 5
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.164
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.298
	Confidence Interval	(2-Sided) 95%; -0.72 to 0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 6

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.008
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.573
	Confidence Interval	(2-Sided) 95%; -1.00 to -0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 7

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 7
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.082
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.376
	Confidence Interval	(2-Sided) 95%; -0.80 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 8

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.296
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.231
	Confidence Interval	(2-Sided) 95%; -0.67 to 0.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 9

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 9
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.383
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.191
	Confidence Interval	(2-Sided) 95%; -0.62 to 0.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 10

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 10
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.048
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.464
	Confidence Interval	(2-Sided) 95%; -0.92 to -0.00
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 11

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 11
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.469
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.172
	Confidence Interval	(2-Sided) 95%; -0.64 to 0.29
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 12

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.151
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.340
	Confidence Interval	(2-Sided) 95%; -0.80 to 0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 13

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 13
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.145
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.344
	Confidence Interval	(2-Sided) 95%; -0.81 to 0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 14

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 14
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.297
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.235
	Confidence Interval	(2-Sided) 95%; -0.68 to 0.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 15

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 15
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.094
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.380
	Confidence Interval	(2-Sided) 95%; -0.82 to 0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 16

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 16
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.064
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.430
	Confidence Interval	(2-Sided) 95%; -0.89 to 0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 17

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 17
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.563
	Confidence Interval	(2-Sided) 95%; -1.03 to -0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 18

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 18
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.044
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.457
	Confidence Interval	(2-Sided) 95%; -0.90 to -0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 19

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 19
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.633
	Confidence Interval	(2-Sided) 95%; -1.09 to -0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 20

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 20
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.348
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.222
	Confidence Interval	(2-Sided) 95%; -0.69 to 0.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 21

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 21
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.243
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.281
	Confidence Interval	(2-Sided) 95%; -0.76 to 0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 22

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 22
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.014
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.595
	Confidence Interval	(2-Sided) 95%; -1.07 to -0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 23

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 23
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.055
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.474
	Confidence Interval	(2-Sided) 95%; -0.96 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 24

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.062
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.464
	Confidence Interval	(2-Sided) 95%; -0.95 to 0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 25

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 25
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.079
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.430
	Confidence Interval	(2-Sided) 95%; -0.91 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 26

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 26
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.576
	Confidence Interval	(2-Sided) 95%; -1.06 to -0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 27

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 27
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.056
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.480
	Confidence Interval	(2-Sided) 95%; -0.97 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 28

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM iTNSS at Day 28
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.018
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.659
	Confidence Interval	(2-Sided) 95%; -1.20 to -0.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 29

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.194
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.222
	Confidence Interval	(2-Sided) 95%; -0.56 to 0.1
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 30

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 2
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.134
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.263
	Confidence Interval	(2-Sided) 95%; -0.61 to 0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 31

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 3
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.091
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.310
	Confidence Interval	(2-Sided) 95%; -0.67 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 32

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.131
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.278
	Confidence Interval	(2-Sided) 95%; -0.64 to 0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 33

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 5
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.483
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.130
	Confidence Interval	(2-Sided) 95%; -0.49 to 0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 34

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.137
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.301
	Confidence Interval	(2-Sided) 95%; -0.70 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 35

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 7
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.142
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.297
	Confidence Interval	(2-Sided) 95%; -0.69 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 36

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.220
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.245
	Confidence Interval	(2-Sided) 95%; -0.64 to 0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 37

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 9
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.081
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.373
	Confidence Interval	(2-Sided) 95%; -0.79 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 38

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 10
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.034
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.453
	Confidence Interval	(2-Sided) 95%; -0.87 to -0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 39

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 11
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.150
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.314
	Confidence Interval	(2-Sided) 95%; -0.74 to 0.11
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 40

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.111
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.333
	Confidence Interval	(2-Sided) 95%; -0.74 to 0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 41

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 13
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.261
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.250
	Confidence Interval	(2-Sided) 95%; -0.69 to 0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 42

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 14
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.123
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.342
	Confidence Interval	(2-Sided) 95%; -0.78 to 0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 43

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 15
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.056
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.415
	Confidence Interval	(2-Sided) 95%; -0.84 to 0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 44

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 16
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.011
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.566
	Confidence Interval	(2-Sided) 95%; -1.00 to -0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 45

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 17
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.590
	Confidence Interval	(2-Sided) 95%; -1.03 to -0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 46

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 18
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.175
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.301
	Confidence Interval	(2-Sided) 95%; -0.74 to 0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 47

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 19
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.039
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.449
	Confidence Interval	(2-Sided) 95%; -0.87 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 48

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 20
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.152
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.315
	Confidence Interval	(2-Sided) 95%; -0.75 to 0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 49

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 21
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.063
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.424
	Confidence Interval	(2-Sided) 95%; -0.87 to 0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 50

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 22
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.044
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.454
	Confidence Interval	(2-Sided) 95%; -0.90 to -0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 51

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 23
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.179
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.312
	Confidence Interval	(2-Sided) 95%; -0.77 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 52

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.034
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.479
	Confidence Interval	(2-Sided) 95%; -0.92 to -0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 53

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 25
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.505
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.157
	Confidence Interval	(2-Sided) 95%; -0.62 to 0.31
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 54

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 26
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.186
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.317
	Confidence Interval	(2-Sided) 95%; -0.79 to 0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 55

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 27
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.234
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.283
	Confidence Interval	(2-Sided) 95%; -0.75 to 0.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 56

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for rTNSS at Day 28
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.017
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.645
	Confidence Interval	(2-Sided) 95%; -1.17 to -0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 57

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.095
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.320
	Confidence Interval	(2-Sided) 95%; -0.70 to 0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 58

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 2
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.236
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.231
	Confidence Interval	(2-Sided) 95%; -0.61 to 0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 59

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 3
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.205
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.255
	Confidence Interval	(2-Sided) 95%; -0.65 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 60

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.084
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.343
	Confidence Interval	(2-Sided) 95%; -0.73 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 61

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 5
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.475
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.146
	Confidence Interval	(2-Sided) 95%; -0.55 to 0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 62

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.178
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.296
	Confidence Interval	(2-Sided) 95%; -0.73 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 63

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 7
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.071
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.406
	Confidence Interval	(2-Sided) 95%; -0.85 to 0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 64

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.621
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.111
	Confidence Interval	(2-Sided) 95%; -0.55 to 0.33
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 65

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 9
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.372
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.206
	Confidence Interval	(2-Sided) 95%; -0.66 to 0.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 66

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 10
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.046
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.452
	Confidence Interval	(2-Sided) 95%; -0.90 to -0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 67

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 11
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.183
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.302
	Confidence Interval	(2-Sided) 95%; -0.75 to 0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 68

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.320
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.226
	Confidence Interval	(2-Sided) 95%; -0.67 to 0.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 69

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 13
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.431
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.188
	Confidence Interval	(2-Sided) 95%; -0.66 to 0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 70

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 14
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.191
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.299
	Confidence Interval	(2-Sided) 95%; -0.75 to 0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 71

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 15
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.043
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.475
	Confidence Interval	(2-Sided) 95%; -0.94 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 72

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 16
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.619
	Confidence Interval	(2-Sided) 95%; -1.08 to -0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 73

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 17
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.040
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.495
	Confidence Interval	(2-Sided) 95%; -0.97 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 74

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 18
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.249
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.262
	Confidence Interval	(2-Sided) 95%; -0.71 to 0.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 75

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 19
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.023
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.536
	Confidence Interval	(2-Sided) 95%; -1.00 to -0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 76

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 20
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.321
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.240
	Confidence Interval	(2-Sided) 95%; -0.71 to 0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 77

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 21
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.019
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.568
	Confidence Interval	(2-Sided) 95%; -1.04 to -0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 78

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 22
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.092
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.419
	Confidence Interval	(2-Sided) 95%; -0.91 to 0.07
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 79

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 23
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.404
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.206
	Confidence Interval	(2-Sided) 95%; -0.69 to 0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 80

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.546
	Confidence Interval	(2-Sided) 95%; -1.03 to -0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 81

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 25
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.357
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.227
	Confidence Interval	(2-Sided) 95%; -0.71 to 0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 82

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 26
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.114
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.403
	Confidence Interval	(2-Sided) 95%; -0.90 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 83

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 27
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.228
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.307
	Confidence Interval	(2-Sided) 95%; -0.81 to 0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 84

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for AM rTNSS at Day 28
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.012
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.725
	Confidence Interval	(2-Sided) 95%; -1.29 to -0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 85

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 1
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.643
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.093
	Confidence Interval	(2-Sided) 95%; -0.49 to 0.30
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 86

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 2
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.150
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.279
	Confidence Interval	(2-Sided) 95%; -0.66 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 87

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 3
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.162
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.291
	Confidence Interval	(2-Sided) 95%; -0.70 to 0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 88

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 4
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.242
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.244
	Confidence Interval	(2-Sided) 95%; -0.65 to 0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 89

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 5
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.278
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.223
	Confidence Interval	(2-Sided) 95%; -0.63 to 0.18
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 90

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 6
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.200
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.282
	Confidence Interval	(2-Sided) 95%; -0.71 to 0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 91

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 7
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.456
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.164
	Confidence Interval	(2-Sided) 95%; -0.60 to 0.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 92

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 8
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.076
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.385
	Confidence Interval	(2-Sided) 95%; -0.81 to 0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 93

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 9
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.084
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.396
	Confidence Interval	(2-Sided) 95%; -0.85 to 0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 94

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 10
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.040
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.481
	Confidence Interval	(2-Sided) 95%; -0.94 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 95

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 11
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.090
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.405
	Confidence Interval	(2-Sided) 95%; -0.87 to 0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 96

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 12
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.060
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.432
	Confidence Interval	(2-Sided) 95%; -0.88 to 0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 97

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 13
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.252
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.277
	Confidence Interval	(2-Sided) 95%; -0.75 to 0.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 98

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 14
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.229
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.300
	Confidence Interval	(2-Sided) 95%; -0.79 to 0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 99

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 15
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.109
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.373
	Confidence Interval	(2-Sided) 95%; -0.83 to 0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 100

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 16
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.484
	Confidence Interval	(2-Sided) 95%; -0.96 to -0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 101

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 17
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.700
	Confidence Interval	(2-Sided) 95%; -1.17 to -0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 102

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 18
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.182
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.326
	Confidence Interval	(2-Sided) 95%; -0.81 to 0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 103

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 19
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.194
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.299
	Confidence Interval	(2-Sided) 95%; -0.75 to 0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 104

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 20
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.129
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.348
	Confidence Interval	(2-Sided) 95%; -0.80 to 0.10
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 105

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 21
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.232
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.292
	Confidence Interval	(2-Sided) 95%; -0.77 to 0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 106

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 22
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.042
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.499
	Confidence Interval	(2-Sided) 95%; -0.98 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 107

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 23
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.150
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.356
	Confidence Interval	(2-Sided) 95%; -0.84 to 0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 108

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 24
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.090
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.398
	Confidence Interval	(2-Sided) 95%; -0.86 to 0.06
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 109

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 25
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.909
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.028
	Confidence Interval	(2-Sided) 95%; -0.52 to 0.46
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 110

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 26
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.354
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.233
	Confidence Interval	(2-Sided) 95%; -0.73 to 0.26
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 111

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 27
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.245
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.290
	Confidence Interval	(2-Sided) 95%; -0.78 to 0.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 112

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate 110 mcg QD
	Comments	Placebo versus Fluticasone Furoate 110 mcg QD for PM rTNSS at Day 28
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	0.038
	Comments
	Method	ANCOVA
	Comments	ANCOVA method was used adjusting for baseline rTNSS, country, age, and gender, in addition to treatment effect.
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	-0.601
	Confidence Interval	(2-Sided) 95%; -1.17 to -0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	AEs were collected from screening up to 32 days
Adverse Event Reporting Description	ITT Population (participants who were randomized and received at least one dose of study drug was used for the analysis of serious adverse event (SAE) and non-serious AEs. Non-serious AEs have been reported for the treatment period (28 days).
Arm/Group Title	Placebo		Fluticasone Furoate 110mcg QD
Arm/Group Description	Participants received placebo matching with GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.		Participants received GW685698X aqueous nasal spray 110 mcg administered as two sprays from the device into each nostril once daily every morning up to 4 weeks.
All Cause Mortality
	Placebo		Fluticasone Furoate 110mcg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/173 (0%)		0/179 (0%)
Serious Adverse Events
	Placebo		Fluticasone Furoate 110mcg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/173 (0%)		0/179 (0%)
Other (Not Including Serious) Adverse Events
	Placebo		Fluticasone Furoate 110mcg QD
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	65/173 (37.6%)		61/179 (34.1%)
Blood and lymphatic system disorders
Anaemia	0/173 (0%)		1/179 (0.6%)
Lymphadenopathy	1/173 (0.6%)		0/179 (0%)
Ear and labyrinth disorders
Ear pain	1/173 (0.6%)		1/179 (0.6%)
Hearing impaired	1/173 (0.6%)		0/179 (0%)
Tinnitus	0/173 (0%)		1/179 (0.6%)
Tympanic membrane disorder	1/173 (0.6%)		0/179 (0%)
Vertigo	0/173 (0%)		1/179 (0.6%)
Eye disorders
Dry eye	2/173 (1.2%)		2/179 (1.1%)
Conjunctivitis	2/173 (1.2%)		0/179 (0%)
Eye pruritus	0/173 (0%)		2/179 (1.1%)
Conjunctival oedema	1/173 (0.6%)		0/179 (0%)
Lacrimation decreased	0/173 (0%)		1/179 (0.6%)
Lacrimation increased	0/173 (0%)		1/179 (0.6%)
Ocular hyperaemia	1/173 (0.6%)		0/179 (0%)
Gastrointestinal disorders
Diarrhoea	0/173 (0%)		5/179 (2.8%)
Abdominal pain	1/173 (0.6%)		2/179 (1.1%)
Nausea	1/173 (0.6%)		2/179 (1.1%)
Abdominal pain upper	0/173 (0%)		2/179 (1.1%)
Dyspepsia	2/173 (1.2%)		0/179 (0%)
Stomach discomfort	1/173 (0.6%)		1/179 (0.6%)
Toothache	1/173 (0.6%)		1/179 (0.6%)
Colitis ulcerative	1/173 (0.6%)		0/179 (0%)
Dry mouth	0/173 (0%)		1/179 (0.6%)
Gastric disorder	0/173 (0%)		1/179 (0.6%)
Glossodynia	1/173 (0.6%)		0/179 (0%)
Oral pain	1/173 (0.6%)		0/179 (0%)
Tongue haemorrhage	1/173 (0.6%)		0/179 (0%)
Tongue ulceration	0/173 (0%)		1/179 (0.6%)
Vomiting	0/173 (0%)		1/179 (0.6%)
General disorders
Asthenia	0/173 (0%)		1/179 (0.6%)
Chest discomfort	0/173 (0%)		1/179 (0.6%)
Fatigue	1/173 (0.6%)		0/179 (0%)
Ill-defined disorder	0/173 (0%)		1/179 (0.6%)
Influenza like illness	1/173 (0.6%)		0/179 (0%)
Injection site pain	0/173 (0%)		1/179 (0.6%)
Irritability	1/173 (0.6%)		0/179 (0%)
Malaise	1/173 (0.6%)		0/179 (0%)
Pain	0/173 (0%)		1/179 (0.6%)
Pyrexia	1/173 (0.6%)		0/179 (0%)
Hepatobiliary disorders
Biliary colic	1/173 (0.6%)		0/179 (0%)
Infections and infestations
Nasopharyngitis	8/173 (4.6%)		8/179 (4.5%)
Upper respiratory tract infection	4/173 (2.3%)		1/179 (0.6%)
Influenza	0/173 (0%)		2/179 (1.1%)
Sinusitis	1/173 (0.6%)		1/179 (0.6%)
Urinary tract infection	2/173 (1.2%)		0/179 (0%)
Viral infection	1/173 (0.6%)		1/179 (0.6%)
Acute tonsillitis	0/173 (0%)		1/179 (0.6%)
Cellulitis	1/173 (0.6%)		0/179 (0%)
Cystitis	1/173 (0.6%)		0/179 (0%)
Gastroenteritis	1/173 (0.6%)		0/179 (0%)
Gastroenteritis viral	1/173 (0.6%)		0/179 (0%)
Herpes simplex	1/173 (0.6%)		0/179 (0%)
Perianal abscess	0/173 (0%)		1/179 (0.6%)
Tooth infection	0/173 (0%)		1/179 (0.6%)
Viral pharyngitis	1/173 (0.6%)		0/179 (0%)
Injury, poisoning and procedural complications
Arthropod sting	0/173 (0%)		1/179 (0.6%)
Back injury	0/173 (0%)		1/179 (0.6%)
Contusion	0/173 (0%)		1/179 (0.6%)
Muscle strain	0/173 (0%)		1/179 (0.6%)
Procedural pain	0/173 (0%)		1/179 (0.6%)
Skin laceration	1/173 (0.6%)		0/179 (0%)
Investigations
Blood pressure increased	1/173 (0.6%)		0/179 (0%)
Electrocardiogram T wave inversion	0/173 (0%)		1/179 (0.6%)
Liver function test abnormal	1/173 (0.6%)		0/179 (0%)
Metabolism and nutrition disorders
Increased appetite	1/173 (0.6%)		0/179 (0%)
Musculoskeletal and connective tissue disorders
Back pain	2/173 (1.2%)		3/179 (1.7%)
Myalgia	2/173 (1.2%)		2/179 (1.1%)
Neck pain	3/173 (1.7%)		0/179 (0%)
Pain in extremity	3/173 (1.7%)		0/179 (0%)
Arthralgia	1/173 (0.6%)		1/179 (0.6%)
Shoulder pain	1/173 (0.6%)		1/179 (0.6%)
Nervous system disorders
Headache	23/173 (13.3%)		12/179 (6.7%)
Sinus headache	3/173 (1.7%)		2/179 (1.1%)
Migraine	0/173 (0%)		2/179 (1.1%)
Dizziness	1/173 (0.6%)		0/179 (0%)
Paraesthesia	1/173 (0.6%)		0/179 (0%)
Tension headache	0/173 (0%)		1/179 (0.6%)
Psychiatric disorders
Insomnia	1/173 (0.6%)		2/179 (1.1%)
Reproductive system and breast disorders
Dysmenorrhoea	3/173 (1.7%)		1/179 (0.6%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	4/173 (2.3%)		4/179 (2.2%)
Pharyngolaryngeal pain	1/173 (0.6%)		5/179 (2.8%)
Dysphonia	1/173 (0.6%)		2/179 (1.1%)
Cough	0/173 (0%)		2/179 (1.1%)
Nasal congestion	2/173 (1.2%)		0/179 (0%)
Nasal discomfort	0/173 (0%)		2/179 (1.1%)
Nasal mucosal disorder	0/173 (0%)		1/179 (0.6%)
Nasal polyps	0/173 (0%)		1/179 (0.6%)
Nasal septum ulceration	1/173 (0.6%)		0/179 (0%)
Nasal ulcer	1/173 (0.6%)		0/179 (0%)
Rhinorrhoea	0/173 (0%)		1/179 (0.6%)
Sinus congestion	0/173 (0%)		1/179 (0.6%)
Throat irritation	1/173 (0.6%)		0/179 (0%)
Skin and subcutaneous tissue disorders
Rash	1/173 (0.6%)		1/179 (0.6%)
Dermatitis allergic	1/173 (0.6%)		0/179 (0%)
Rash papular	1/173 (0.6%)		0/179 (0%)
Urticaria	1/173 (0.6%)		0/179 (0%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.