Once-Daily Investigational Nasal Spray In Adults And Adolescents With Perennial Allergic Rhinitis (PAR)

Sponsor

GlaxoSmithKline (Industry)

Overall Status

Completed

CT.gov ID

NCT00289198

Collaborator

(none)

301

Enrollment

Locations

Arms

4.8

Duration (Months)

7.2

Patients Per Site

1.5

Patients Per Site Per Month

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 perennial allergic rhinitis (PAR).

Condition or Disease	Intervention/Treatment	Phase
Rhinitis, Allergic, Perennial	Drug: FF Drug: Placebo	Phase 3

Detailed Description

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 years of Age and Older with Perennial Allergic Rhinitis (PAR)

Study Design

Study Type:

Interventional

Actual Enrollment :

301 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Primary Purpose:

Treatment

Official Title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Once-Daily Intranasal Administration of GW685698X Aqueous Nasal Spray 100mcg for 6 Weeks in Adult and Adolescent Subjects 12 Years of Age and Older With Perennial Allergic Rhinitis (PAR)

Study Start Date :

Feb 7, 2006

Actual Primary Completion Date :

Jul 1, 2006

Actual Study Completion Date :

Jul 4, 2006

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fluticasone furoate Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg	Drug: FF fluticasone furoate 110 μg nasal spray
Placebo Comparator: Placebo Participants were instructed to administer two sprays into each nostril once daily every morning of placebo	Drug: Placebo placebo nasal spray

Arm

Intervention/Treatment

Experimental: Fluticasone furoate

Participants were instructed to administer two sprays into each nostril once daily every morning of fluticasone furoate 110 μg

Drug: FF

fluticasone furoate 110 μg nasal spray

Placebo Comparator: Placebo

Participants were instructed to administer two sprays into each nostril once daily every morning of placebo

Drug: Placebo

placebo nasal spray

Outcome Measures

Primary Outcome Measures

Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks [Baseline (Day 1) and up to Week 6]
TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed

Secondary Outcome Measures

Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period [Baseline (Day 1) and up to Week 6]
The AM pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each individual symptom score ranged on a scale of 0 to 3 where 0 indicated healthy condition and 3 indicated severity of the symptoms. The total score ranged on a scale of 0 to 12 where 0 indicated healthy condition and 12 indicated worst condition of symptoms. Baseline iTNSS is defined as the average of the non-missing values for iTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Number of Participants With Response to Therapy Over Entire Treatment Period [Up to 6 weeks]
Response to therapy is defined as the effectiveness of FF for relieving allergic rhinitis symptoms over the entire treatment period. Response was, evaluated at the end of the study (Week 6) using a 7-point categorical scale, categorized as: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, 7=significantly worse. Analysis was performed using logistic regression to evaluate treatment effect, adjusting for age, gender, and country. Effectiveness of the study drug for relieving allergic rhinitis symptoms over the entire treatment period was compared with Placebo.
Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The AM rTNSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The PM rTNSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed
Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period [Baseline and up to 6 weeks]
TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The BL daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using ANCOVA, adjusting for BL daily rTNSS, country, age, and gender. Only those participants available at the specified time points were analyzed. Change from Baseline is the value at indicated time-point minus the baseline value*100.
Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
The individual nasal symptom scores (INSS) for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The INSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily INSS is defined as average of the PM INSS and the AM INSS of the next day prior to AM dosing. The Baseline daily INSS is defined as the average of the daily INSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily INSS minus Baseline daily INSS. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
The iINSS score for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM pre-dose iINSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iINSS is defined as the average of the non-missing values for iINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment [Baseline (Day 1) and up to 6 weeks]
INSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM rINSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
rINSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The PM rINSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
TOSS is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The rTOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily rTOSS is defined as average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The BL daily rTOSS is defined as the average of the daily rTOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily rTOSS minus BL daily rTOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The AM pre-dose iTOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iTOSS is defined as the average of the non-missing values for iTOSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates more severe symptoms. The AM rTOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed
Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The PM rTOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
Individual ocular symptom scores (IOSS) for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The IOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily IOSS is defined as average of the PM IOSS and the AM IOSS of the next day prior to AM dosing. The BL daily IOSS is defined as the average of the daily IOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily IOSS minus BL daily IOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.
Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM pre-dose iIOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iIOSS is defined as the average of the non-missing values for iIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
rIOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM rIOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The PM rIOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication), and 12 hours later in the PM (after recording allergy symptoms). Three measurements were taken and the highest measurement recorded on the electronic diary. Daily PNIF is defined as average of PM PNIF and AM PNIF of the next day prior to AM dosing. The Baseline is defined as average of the last 8 readings (4 AM and 4 PM) of PNIF measurement over the four 24-hour periods prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.
Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. AM PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication). Three measurements were taken and the highest measurement recorded on the electronic diary. Baseline AM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period [Baseline (Day 1) and up to 6 weeks]
The PNIF score is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PM PNIF measurements was completed and recorded after assessment of allergy symptoms in the PM (12 hours after study medication). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Baseline PM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the 4 consecutive days prior to randomization. Change from baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of perennial allergic rhinitis (PAR).
Must comply with study procedures and be literate.

Exclusion Criteria:

Significant concomitant medical conditions.
Use of corticosteroids.
Use of allergy and other identified medications during the study.
Current tobacco use or tobacco use within the past year.
Exposure to an investigational study drug within the past 12 months.
Clinically significant abnormal electrocardiograms (ECG) or laboratory abnormality.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	San Diego	California	United States	92123
2	GSK Investigational Site	Baltimore	Maryland	United States	21236
3	GSK Investigational Site	Wheaton	Maryland	United States	20902
4	GSK Investigational Site	North Dartmouth	Massachusetts	United States	02747
5	GSK Investigational Site	Minneapolis	Minnesota	United States	55402
6	GSK Investigational Site	Canton	Ohio	United States	44718
7	GSK Investigational Site	Providence	Rhode Island	United States	02906
8	GSK Investigational Site	South Burlington	Vermont	United States	05403
9	GSK Investigational Site	Camperdown	New South Wales	Australia	2050
10	GSK Investigational Site	Kippa Ring	Queensland	Australia	4021
11	GSK Investigational Site	Toorak Gardens	South Australia	Australia	5065
12	GSK Investigational Site	Clayton	Victoria	Australia	3169
13	GSK Investigational Site	Melbourne	Victoria	Australia	3004
14	GSK Investigational Site	Parkville	Victoria	Australia	3052
15	GSK Investigational Site	Nedlands	Western Australia	Australia	6009
16	GSK Investigational Site	Mississauga	Ontario	Canada	L5A 1N1
17	GSK Investigational Site	Ottawa	Ontario	Canada	K1Y 4G2
18	GSK Investigational Site	Toronto	Ontario	Canada	M9W 4L6
19	GSK Investigational Site	Trois Rivieres	Quebec	Canada	G8T 7A1
20	GSK Investigational Site	Tallinn		Estonia	13419
21	GSK Investigational Site	Tartu		Estonia	51014
22	GSK Investigational Site	Schwerin	Mecklenburg-Vorpommern	Germany	19055
23	GSK Investigational Site	Berlin		Germany	13125
24	GSK Investigational Site	Berlin		Germany	14057
25	GSK Investigational Site	Hamburg		Germany	20249
26	GSK Investigational Site	Dobele		Latvia	LV 3701
27	GSK Investigational Site	Liepaja		Latvia	LV3401
28	GSK Investigational Site	Riga		Latvia	LV1001
29	GSK Investigational Site	Riga		Latvia	LV1021
30	GSK Investigational Site	Tukums		Latvia	LV 3100
31	GSK Investigational Site	Kaunas		Lithuania	LT-50009
32	GSK Investigational Site	Siauliai		Lithuania	LT-76231
33	GSK Investigational Site	Vilnius		Lithuania	LT-01117
34	GSK Investigational Site	Vilnius		Lithuania	LT-08661
35	GSK Investigational Site	Vilnius		Lithuania	LT-09311
36	GSK Investigational Site	Auckland		New Zealand	1311
37	GSK Investigational Site	Auckland		New Zealand	1701
38	GSK Investigational Site	Grafton		New Zealand	1001
39	GSK Investigational Site	Moscow		Russian Federation	123 182
40	GSK Investigational Site	Moscow		Russian Federation	123095
41	GSK Investigational Site	Moscow		Russian Federation	129010
42	GSK Investigational Site	Saint-Petersburg		Russian Federation	190013

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:

NCT00289198

Other Study ID Numbers:

FFR106080

First Posted:

Feb 9, 2006

Last Update Posted:

Apr 13, 2018

Last Verified:

Sep 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Keywords provided by GlaxoSmithKline

GW685698X

perennial allergic rhinitis

allergic rhinitis

Additional relevant MeSH terms:

Rhinitis

Rhinitis, Allergic

Rhinitis, Allergic, Perennial

Study Results

Participant Flow

Recruitment Details	This study was conducted from 07 February 2006 till 23 June 2006 at 40 centers across the globe. A total of 288 participants with perennial allergic rhinitis (PAR) were planned to be enrolled.
Pre-assignment Detail	Following a 7 to 14 day screening period, participants who met randomisation criteria were randomised to 6 weeks of treatment with fluticasone furoate or placebo nasal spray once daily. A total of 302 participants were randomised, 151 in each of the treatment groups.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray (27.5 mcg per spray) into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Period Title: Overall Study
STARTED	151	151
COMPLETED	120	121
NOT COMPLETED	31	30

Baseline Characteristics

Arm/Group Title	Fluticasone Furoate	Placebo	Total
Arm/Group Description	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Total of all reporting groups
Overall Participants	151	151	302
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	37.1 (16.57)	37.2 (16.20)	37.1 (16.36)
Sex: Female, Male (Count of Participants)
Female	85 56.3%	86 57%	171 56.6%
Male	66 43.7%	65 43%	131 43.4%
Race/Ethnicity, Customized (Number) [Number]
African American/African Heritage	4 2.6%	3 2%	7 2.3%
American Indian or Alaska Native	0 0%	1 0.7%	1 0.3%
Asian - Central/South Asian Heritage	2 1.3%	1 0.7%	3 1%
Asian - East Asian Heritage	1 0.7%	1 0.7%	2 0.7%
Asian - South East Asian Heritage	6 4%	4 2.6%	10 3.3%
Native Hawaiian or other Pacific Islander	3 2%	0 0%	3 1%
White - Arabic/North African Heritage	0 0%	1 0.7%	1 0.3%
White - White/Caucasian/European Heritage	135 89.4%	139 92.1%	274 90.7%
Mixed Race	0 0%	1 0.7%	1 0.3%

Outcome Measures

1. Primary Outcome

Title	Mean Change From Baseline (Day 1) Over the Entire Treatment Period in Daily, Reflective Total Nasal Symptom Scores (rTNSS) Over 6 Weeks
Description	TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed
Time Frame	Baseline (Day 1) and up to Week 6

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	150	151
Least Squares Mean (Standard Error) [Scores on a scale]	-2.69 (0.18)	-3.95 (0.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Change from Baseline (Day 1) in reflective total nasal symptom scores for Placebo versus that for fluticasone furoate
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.256
	Confidence Interval	(2-Sided) 95% -1.73 to -0.78
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in AM, Pre-dose, Instantaneous Total Nasal Symptom (iTNSS) Scores Over the Entire Treatment Period
Description	The AM pre-dose iTNSS is the sum of the 4 individual nasal symptom score assessments for rhinorrhea, nasal congestion, nasal itching, and sneezing performed at the moment immediately prior to taking the daily dose; each individual symptom score ranged on a scale of 0 to 3 where 0 indicated healthy condition and 3 indicated severity of the symptoms. The total score ranged on a scale of 0 to 12 where 0 indicated healthy condition and 12 indicated worst condition of symptoms. Baseline iTNSS is defined as the average of the non-missing values for iTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame	Baseline (Day 1) and up to Week 6

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	149	150
Least Squares Mean (Standard Error) [Scores on a scale]	-2.36 (0.18)	-3.82 (0.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments	Mean change from Baseline in AM pre-dose instantaneous TNSS over entire period for Placebo versus that for Fluticasone furoate
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.459
	Confidence Interval	(2-Sided) 95% -1.93 to -0.99
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Number of Participants With Response to Therapy Over Entire Treatment Period
Description	Response to therapy is defined as the effectiveness of FF for relieving allergic rhinitis symptoms over the entire treatment period. Response was, evaluated at the end of the study (Week 6) using a 7-point categorical scale, categorized as: 1=significantly improved, 2=moderately improved, 3=mildly improved, 4=no change, 5=mildly worse, 6=moderately worse, 7=significantly worse. Analysis was performed using logistic regression to evaluate treatment effect, adjusting for age, gender, and country. Effectiveness of the study drug for relieving allergic rhinitis symptoms over the entire treatment period was compared with Placebo.
Time Frame	Up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	151	151
Significantly Improved	21 13.9%	56 37.1%
Moderately Improved	38 25.2%	37 24.5%
Mildly Improved	37 24.5%	31 20.5%
No Change	45 29.8%	20 13.2%
Mildly Worse	5 3.3%	2 1.3%
Moderately Worse	3 2%	3 2%
Significantly Worse	2 1.3%	2 1.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Regression, Logistic
	Comments	Based on logistic regression adjusting for age, gender and country

4. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in AM rTNSS Over the Entire Treatment Period
Description	TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The AM rTNSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	149	150
Least Squares Mean (Standard Error) [Scores on a scale]	-2.66 (0.17)	-3.93 (0.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.274
	Confidence Interval	(2-Sided) 95% -1.74 to -0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in PM rTNSS Over the Entire Treatment Period
Description	TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The PM rTNSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTNSS is defined as the average of the non-missing values for rTNSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	150	150
Least Squares Mean (Standard Error) [Scores on a scale]	-2.73 (0.18)	-4.02 (0.18)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-1.291
	Confidence Interval	(2-Sided) 95% -1.77 to -0.81
	Parameter Dispersion	Type: Value:
	Estimation Comments

6. Secondary Outcome

Title	Mean Percent Change From Baseline (Day 1) in Daily rTNSS Over the Entire Treatment Period
Description	TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The Baseline daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24 hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using analysis of covariance (ANCOVA), adjusting for Baseline daily rTNSS, country, age, and gender. The Intent To Treat (ITT) Population comprised of all randomized participants who received >=1 dose of study drug. Only those participants available at the specified time points were analyzed
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	150	151
Least Squares Mean (Standard Error) [Percent change]	-30.23 (2.22)	-44.35 (2.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-14.118
	Confidence Interval	(2-Sided) 95% -20.03 to -8.21
	Parameter Dispersion	Type: Value:
	Estimation Comments

7. Secondary Outcome

Title	Mean Percent Change From Baseline (Day 1) in AM Pre-Dose iTNSS Over the Entire Treatment Period
Description	TNSS is the sum of symptom scores for rhinorrhea, nasal congestion, nasal itching, and sneezing (each scored on a scale of 0 [none] to 3 [severe]; total possible score of 0 to 12). The rTNSS is a rating of the severity of symptoms over the previous 12 hours and is performed in morning (AM) and evening (PM). Daily rTNSS is defined as average of the PM rTNSS and the AM rTNSS of the next day prior to AM dosing. The BL daily rTNSS is defined as the average of the daily rTNSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily rTNSS minus Baseline daily rTNSS. Analysis was performed using ANCOVA, adjusting for BL daily rTNSS, country, age, and gender. Only those participants available at the specified time points were analyzed. Change from Baseline is the value at indicated time-point minus the baseline value*100.
Time Frame	Baseline and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	149	150
Least Squares Mean (Standard Error) [Percent change]	-24.67 (2.66)	-44.70 (2.66)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-20.033
	Confidence Interval	(2-Sided) 95% -27.13 to -12.94
	Parameter Dispersion	Type: Value:
	Estimation Comments

8. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in Daily Reflective Individual Nasal Symptom Scores (rINSS) Over the Entire Treatment Period
Description	The individual nasal symptom scores (INSS) for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The INSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily INSS is defined as average of the PM INSS and the AM INSS of the next day prior to AM dosing. The Baseline daily INSS is defined as the average of the daily INSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from Baseline was calculated as average of the non-missing daily INSS minus Baseline daily INSS. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Only those participants available at the time of assessment were analyzed.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	150	151
Rhinorrhea	-0.67 (0.05)	-0.94 (0.05)
Nasal Congestion	-0.69 (0.05)	-0.97 (0.05)
Nasal Itching	-0.65 (0.05)	-0.98 (0.05)
Sneezing	-0.68 (0.05)	-1.07 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Rhinorrhea score, Placebo vs Fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.277
	Confidence Interval	(2-Sided) 95% -0.41 to -0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Nasal Congestion, Placebo vs Fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.277
	Confidence Interval	(2-Sided) 95% -0.42 to -0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Nasal Itching, Placebo vs Fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.331
	Confidence Interval	(2-Sided) 95% -0.47 to -0.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Sneezing score, Placebo vs Fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.390
	Confidence Interval	(2-Sided) 95% -0.52 to -0.27
	Parameter Dispersion	Type: Value:
	Estimation Comments

9. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous Individual Nasal Symptom Score (iINSS) Over the Entire Treatment Period
Description	The iINSS score for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM pre-dose iINSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iINSS is defined as the average of the non-missing values for iINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	149	150
Rhinorrhea	-0.57 (0.05)	-0.93 (0.05)
Nasal Congestion	-0.55 (0.05)	-0.92 (0.05)
Nasal Itching	-0.61 (0.05)	-0.98 (0.05)
Sneezing	-0.63 (0.05)	-1.00 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Rhinorrhea score, Placebo versus fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.357
	Confidence Interval	(2-Sided) 95% -0.50 to -0.22
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Nasal Congestion score, Placebo versus fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.370
	Confidence Interval	(2-Sided) 95% -0.51 to -0.23
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Nasal itching score, Placebo versus fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.372
	Confidence Interval	(2-Sided) 95% -0.50 to -0.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Sneezing score, Placebo versus fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.372
	Confidence Interval	(2-Sided) 95% -0.50 to -0.24
	Parameter Dispersion	Type: Value:
	Estimation Comments

10. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in AM rINSS Over the Entire Treatment
Description	INSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The AM rINSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	149	150
Rhinorrhea	-0.67 (0.05)	-0.95 (0.05)
Nasal Congestion	-0.66 (0.05)	-0.98 (0.05)
Nasal Itching	-0.64 (0.05)	-0.96 (0.05)
Sneezing	-0.69 (0.05)	-1.06 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Rhinorrhea score,Placebo versus fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.281
	Confidence Interval	(2-Sided) 95% -0.42 to -0.14
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Nasal Congestion score, Placebo versus fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.314
	Confidence Interval	(2-Sided) 95% -0.45 to -0.17
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Nasal itching score, Placebo versus fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.324
	Confidence Interval	(2-Sided) 95% -0.45 to -0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Sneezing score, Placebo versus fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.374
	Confidence Interval	(2-Sided) 95% -0.50 to -0.25
	Parameter Dispersion	Type: Value:
	Estimation Comments

11. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in PM rINSS Over the Entire Treatment Period
Description	rINSS for rhinorrhea, nasal congestion, nasal itching and sneezing were assessed on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates severe symptoms. The PM rINSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rINSS is defined as the average of the non-missing values for rINSS during the Baseline period where the Baseline period included the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those par. available at the specified time points were analyzed.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	150	150
Rhinorrhea	-0.66 (0.05)	-0.96 (0.05)
Nasal Congestion	-0.70 (0.05)	-0.97 (0.05)
Nasal Itching	-0.68 (0.05)	-1.01 (0.05)
Sneezing	-0.68 (0.05)	-1.09 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Rhinorrhea score, Placebo vs Fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.292
	Confidence Interval	() 95% -0.43 to -0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Nasal Congestion score, Placebo vs Fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.264
	Confidence Interval	(2-Sided) 95% -0.40 to -0.12
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Nasal Itching score, Placebo vs Fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.336
	Confidence Interval	(2-Sided) 95% -0.48 to -0.20
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Sneezing score, Placebo vs Fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.412
	Confidence Interval	(2-Sided) 95% -0.54 to -0.28
	Parameter Dispersion	Type: Value:
	Estimation Comments

12. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in Daily Reflective Total Ocular Symptom Score (rTOSS) Over the Entire Treatment Period
Description	TOSS is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The rTOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily rTOSS is defined as average of the PM rTOSS and the AM rTOSS of the next day prior to AM dosing. The BL daily rTOSS is defined as the average of the daily rTOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily rTOSS minus BL daily rTOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	150	151
Mean (Standard Deviation) [Scores on a scale]	-1.41 (0.13)	-1.92 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.506
	Confidence Interval	(2-Sided) 95% -0.85 to -0.16
	Parameter Dispersion	Type: Value:
	Estimation Comments

13. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in AM Pre-dose Instantaneous TOSS (iTOSS) Over the Entire Treatment Period
Description	The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The AM pre-dose iTOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iTOSS is defined as the average of the non-missing values for iTOSS during the Baseline period where the Baseline period included the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	149	150
Least Squares Mean (Standard Error) [Scores on a scale]	-1.26 (0.13)	-1.76 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.007
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.491
	Confidence Interval	() 95% -0.85 to -0.13
	Parameter Dispersion	Type: Value:
	Estimation Comments

14. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in AM rTOSS Over the Entire Treatment Period
Description	The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale and larger score indicates more severe symptoms. The AM rTOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	149	150
Mean (Standard Deviation) [Scores on a scale]	-1.39 (0.13)	-1.92 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.003
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.531
	Confidence Interval	(2-Sided) 95% -0.88 to -0.19
	Parameter Dispersion	Type: Value:
	Estimation Comments

15. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in PM rTOSS Over the Entire Treatment Period
Description	The TOSS score is defined as the sum of the 3 individual ocular symptom scores for itching/burning eyes, tearing/watering eyes, and eye redness, and ranges from 0 to 9. Each symptom is scored on a 4 point (0 [none] to 3 [severe]) categorical scale. The PM rTOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rTOSS is defined as the average of the non-missing values for rTOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender. Only those participants available at the specified time points were analyzed.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	150	150
Least Squares Mean (Standard Error) [Scores on a scale]	-1.44 (0.13)	-1.93 (0.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.496
	Confidence Interval	(2-Sided) 95% -0.84 to -0.15
	Parameter Dispersion	Type: Value:
	Estimation Comments

16. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in Daily Reflective Individual Ocular Symptom Scores (iIOSS) Over the Entire Treatment Period
Description	Individual ocular symptom scores (IOSS) for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The IOSS is a rating of the severity of symptoms over the previous 12 hours and is performed in AM and PM. Daily IOSS is defined as average of the PM IOSS and the AM IOSS of the next day prior to AM dosing. The BL daily IOSS is defined as the average of the daily IOSS over 4 consecutive 24-hour periods prior to randomization plus randomization day AM assessment. Change from BL was calculated as average of the non-missing daily IOSS minus BL daily IOSS. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	150	151
Eye itching/burning	-0.47 (0.05)	-0.69 (0.05)
Eye tearing/watering	-0.48 (0.05)	-0.62 (0.05)
Eye redness	-0.45 (0.04)	-0.61 (0.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Eye itching/burning score, Placebo vs fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.216
	Confidence Interval	(2-Sided) 95% -0.34 to -0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Eye tearing/watering score, Placebo vs fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.028
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.137
	Confidence Interval	(2-Sided) 95% -0.26 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Eye redness, Placebo vs fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.010
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.156
	Confidence Interval	(2-Sided) 95% -0.27 to -0.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

17. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in AM Pre-Dose Instantaneous Individual Ocular Symptom Score (iIOSS) Over the Entire Treatment Period
Description	IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM pre-dose iIOSS is a rating of the severity of symptoms performed at the moment immediately prior to dosing. Baseline iIOSS is defined as the average of the non-missing values for iIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	149	150
Eye itching/burning	-0.39 (0.05)	-0.6 (0.5)
Eye tearing/watering	-0.43 (0.05)	-0.59 (0.05)
Eye redness	-0.45 (0.05)	-0.56 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Eye itching/burning score, Placebo vs fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.215
	Confidence Interval	(2-Sided) 95% -0.35 to -0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Eye tearing or watering, Placebo vs fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.016
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.161
	Confidence Interval	() 95% -0.29 to -0.03
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Eye redness score, Placebo vs fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.076
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.113
	Confidence Interval	(2-Sided) 95% -0.24 to -0.01
	Parameter Dispersion	Type: Value:
	Estimation Comments

18. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in AM Reflective Individual Ocular Symptom Score (rIOSS) Over the Entire Treatment Period
Description	rIOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The AM rIOSS is a rating of the severity of symptoms performed in the morning prior to administering the dose of study drug and assesses how the participant felt during the night (preceding 12 hours). Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline was calculated as score over the entire treatment period minus Baseline value. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	149	150
Eye itching/burning	-0.48 (0.05)	-0.69 (0.05)
Eye tearing/watering	-0.48 (0.05)	-0.62 (0.05)
Eye redness	-0.44 (0.05)	-0.61 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Eye itching/burning score, Placebo vs Fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.211
	Confidence Interval	(2-Sided) 95% -0.34 to -0.08
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Eye tearing/watering, Placebo vs Fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.023
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.145
	Confidence Interval	(2-Sided) 95% -0.27 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Eye Redness score, Placebo vs Fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.005
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.176
	Confidence Interval	(2-Sided) 95% -0.30 to -0.05
	Parameter Dispersion	Type: Value:
	Estimation Comments

19. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in PM rIOSS Over the Entire Treatment Period
Description	IOSS for itching/burning eyes, tearing/watering eyes, and eye redness were assessed on a 4 point (0 [none]to 3 [severe]) categorical scale. The PM rIOSS is a rating of the severity of symptoms performed approximately 12 hours after dosing and before bedtime and assesses how the participant felt during the day. Baseline rIOSS is defined as the average of the non-missing values for rIOSS during the Baseline period where the baseline period includes the 4 consecutive days prior to randomization. Change from Baseline is calculated as the score over the entire treatment period minus the score at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	150	150
Eye itching/burning	-0.47 (0.05)	-0.69 (0.05)
Eye tearing/watering	-0.49 (0.05)	-0.62 (0.05)
Eye redness	-0.47 (0.05)	-0.61 (0.05)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Eye itching/burning, Placebo vs fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.001
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.223
	Confidence Interval	(2-Sided) 95% -0.35 to -0.09
	Parameter Dispersion	Type: Value:
	Estimation Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments	Eye Tearing/Watering score, Placebo vs fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.040
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.130
	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
	Comments	Eye Redness score, Placebo vs fluticasone furoate
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.022
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	-0.142
	Confidence Interval	(2-Sided) 95% -0.26 to -0.02
	Parameter Dispersion	Type: Value:
	Estimation Comments

20. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in Daily Peak Nasal Inspiratory Flow (PNIF) Over the Entire Treatment Period
Description	PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication), and 12 hours later in the PM (after recording allergy symptoms). Three measurements were taken and the highest measurement recorded on the electronic diary. Daily PNIF is defined as average of PM PNIF and AM PNIF of the next day prior to AM dosing. The Baseline is defined as average of the last 8 readings (4 AM and 4 PM) of PNIF measurement over the four 24-hour periods prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for BL value, country, age, and gender.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	150	151
Least Squares Mean (Standard Error) [Liters per minute]	17.35 (2.13)	25.72 (2.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.004
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	8.376
	Confidence Interval	(2-Sided) 95% 2.71 to 14.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

21. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in AM PNIF Over the Entire Treatment Period
Description	PNIF is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. AM PNIF measurements was completed and recorded following assessment of allergy symptoms in the AM (prior to taking study medication). Three measurements were taken and the highest measurement recorded on the electronic diary. Baseline AM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the randomization day and the 3 consecutive days prior to randomization. Change from Baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	149	150
Least Squares Mean (Standard Error) [Liters per minute]	16.33 (2.16)	25.61 (2.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.002
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	9.280
	Confidence Interval	(2-Sided) 95% 3.52 to 15.04
	Parameter Dispersion	Type: Value:
	Estimation Comments

22. Secondary Outcome

Title	Mean Change From Baseline (Day 1) in PM PNIF Over the Entire Treatment Period
Description	The PNIF score is the tool for determining the extent of nasal airway obstruction. Participants used a portable hand-held inspiratory flow meter and face mask to measure and record PNIF. PM PNIF measurements was completed and recorded after assessment of allergy symptoms in the PM (12 hours after study medication). Three measurements were taken on each occasion and the highest measurement recorded on the electronic diary. Baseline PM PNIF is defined as the average of the non-missing values for PNIF during the Baseline period where the Baseline period includes the 4 consecutive days prior to randomization. Change from baseline is calculated as the value over the entire treatment period minus the value at Baseline. Analysis was performed using ANCOVA, adjusting for Baseline value, country, age, and gender.
Time Frame	Baseline (Day 1) and up to 6 weeks

Outcome Measure Data

Analysis Population Description
ITT population. Data is presented for the participants available at the time of assessment.

Arm/Group Title	Placebo	Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.	Eligible participants received aqueous nasal spray of Fluticasone furoate 100 mcg once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
Measure Participants	150	147
Least Squares Mean (Standard Error) [Liters per minute]	18.51 (2.15)	26.15 (2.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Placebo, Fluticasone Furoate
	Comments
	Type of Statistical Test	Superiority or Other
	Comments

Statistical Test of Hypothesis	p-Value	0.009
	Comments
	Method	ANCOVA
	Comments

Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	7.638
	Confidence Interval	(2-Sided) 95% 1.89 to 13.39
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

	Placebo		Fluticasone Furoate
Time Frame	Serious adverse events (SAEs) and non-serious adverse events (nSAEs) were collected from the start of study treatment until follow-up period (Up to 48 days).
Adverse Event Reporting Description	SAEs and non-serious AEs were reported for members of the ITT population that comprised of all participants who were randomised to treatment, and received at least one dose of study drug.

Arm/Group Title	Placebo		Fluticasone Furoate
Arm/Group Description	Eligible participants received aqueous nasal spray of matching Placebo once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.		Eligible participants received aqueous nasal spray of Fluticasone furoate 100 micrograms (mcg) once daily for 6 weeks in a randomized manner. Dose was administered by alternately spraying one spray into each nostril followed by a second spray into each nostril for 42 days. Participants were followed-up telephonically, up to 5 days after the last dose of the study drug.
All Cause Mortality
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/151 (0%)		0/151 (0%)
Serious Adverse Events
	Placebo		Fluticasone Furoate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/151 (0%)		1/151 (0.7%)
Infections and infestations
Acute sinusitis	0/151 (0%)		1/151 (0.7%)
Other (Not Including Serious) Adverse Events
	Placebo		Fluticasone Furoate
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	66/151 (43.7%)		77/151 (51%)
Blood and lymphatic system disorders
Lymphadenopathy	1/151 (0.7%)		1/151 (0.7%)
Anaemia	0/151 (0%)		1/151 (0.7%)
Ear and labyrinth disorders
Motion sickness	1/151 (0.7%)		0/151 (0%)
Eye disorders
Conjunctivitis	0/151 (0%)		2/151 (1.3%)
Vision blurred	1/151 (0.7%)		1/151 (0.7%)
Dry eye	0/151 (0%)		1/151 (0.7%)
Eye pain	1/151 (0.7%)		0/151 (0%)
Ocular hyperaemia	1/151 (0.7%)		0/151 (0%)
Visual disturbance	1/151 (0.7%)		0/151 (0%)
Gastrointestinal disorders
Diarrhoea	2/151 (1.3%)		3/151 (2%)
Nausea	1/151 (0.7%)		4/151 (2.6%)
Dyspepsia	1/151 (0.7%)		2/151 (1.3%)
Abdominal pain upper	0/151 (0%)		2/151 (1.3%)
Dry mouth	1/151 (0.7%)		1/151 (0.7%)
Abdominal distension	0/151 (0%)		1/151 (0.7%)
Abdominal pain	0/151 (0%)		1/151 (0.7%)
Constipation	0/151 (0%)		1/151 (0.7%)
Oral soft tissue disorder	1/151 (0.7%)		0/151 (0%)
Stomach discomfort	0/151 (0%)		1/151 (0.7%)
General disorders
Gastrooesophageal reflux disease	0/151 (0%)		1/151 (0.7%)
Pyrexia	3/151 (2%)		2/151 (1.3%)
Chest pain	1/151 (0.7%)		1/151 (0.7%)
Fatigue	0/151 (0%)		2/151 (1.3%)
Feeling hot	1/151 (0.7%)		1/151 (0.7%)
Thirst	2/151 (1.3%)		0/151 (0%)
Chills	1/151 (0.7%)		0/151 (0%)
Oedema peripheral	1/151 (0.7%)		0/151 (0%)
Pain	0/151 (0%)		1/151 (0.7%)
Immune system disorders
Food allergy	0/151 (0%)		1/151 (0.7%)
Infections and infestations
Nasopharyngitis	7/151 (4.6%)		9/151 (6%)
Upper respiratory tract infection	6/151 (4%)		3/151 (2%)
Influenza	2/151 (1.3%)		3/151 (2%)
Viral infection	1/151 (0.7%)		3/151 (2%)
Gastroenteritis viral	1/151 (0.7%)		1/151 (0.7%)
Bronchitis	0/151 (0%)		1/151 (0.7%)
Fungal infection	1/151 (0.7%)		0/151 (0%)
Gastroenteritis	0/151 (0%)		1/151 (0.7%)
Herpes simplex	1/151 (0.7%)		0/151 (0%)
Nasal candidiasis	1/151 (0.7%)		0/151 (0%)
Pharyngeal candidiasis	0/151 (0%)		1/151 (0.7%)
Pharyngitis	0/151 (0%)		1/151 (0.7%)
Purulent discharge	0/151 (0%)		1/151 (0.7%)
Rhinovirus infection	1/151 (0.7%)		0/151 (0%)
Sinusitis	1/151 (0.7%)		0/151 (0%)
Injury, poisoning and procedural complications
Procedural pain	1/151 (0.7%)		3/151 (2%)
Contusion	1/151 (0.7%)		1/151 (0.7%)
Arthropod bite	1/151 (0.7%)		0/151 (0%)
Fall	0/151 (0%)		1/151 (0.7%)
Joint sprain	1/151 (0.7%)		0/151 (0%)
Ligament rupture	0/151 (0%)		1/151 (0.7%)
Investigations
Blood pressure increased	1/151 (0.7%)		0/151 (0%)
Metabolism and nutrition disorders
Anorexia	1/151 (0.7%)		0/151 (0%)
Fluid retention	0/151 (0%)		1/151 (0.7%)
Musculoskeletal and connective tissue disorders
Muscle tightness	1/151 (0.7%)		2/151 (1.3%)
Back pain	1/151 (0.7%)		1/151 (0.7%)
Arthritis	0/151 (0%)		1/151 (0.7%)
Bone cyst	0/151 (0%)		1/151 (0.7%)
Muscle spasms	0/151 (0%)		1/151 (0.7%)
Musculoskeletal stiffness	0/151 (0%)		1/151 (0.7%)
Myalgia	1/151 (0.7%)		0/151 (0%)
Neck pain	1/151 (0.7%)		0/151 (0%)
Osteoarthritis	0/151 (0%)		1/151 (0.7%)
Pain in extremity	1/151 (0.7%)		0/151 (0%)
Synovial cyst	0/151 (0%)		1/151 (0.7%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid neoplasm	1/151 (0.7%)		0/151 (0%)
Nervous system disorders
Headache	29/151 (19.2%)		27/151 (17.9%)
Dizziness	1/151 (0.7%)		4/151 (2.6%)
Sinus headache	2/151 (1.3%)		1/151 (0.7%)
Migraine	2/151 (1.3%)		0/151 (0%)
Dysgeusia	1/151 (0.7%)		0/151 (0%)
Hyperaesthesia	0/151 (0%)		1/151 (0.7%)
Somnolence	0/151 (0%)		1/151 (0.7%)
Tension headache	0/151 (0%)		1/151 (0.7%)
Tremor	0/151 (0%)		1/151 (0.7%)
Psychiatric disorders
Anxiety	1/151 (0.7%)		1/151 (0.7%)
Insomnia	0/151 (0%)		2/151 (1.3%)
Depression	0/151 (0%)		1/151 (0.7%)
Respiratory, thoracic and mediastinal disorders
Epistaxis	6/151 (4%)		13/151 (8.6%)
Pharyngolaryngeal pain	6/151 (4%)		13/151 (8.6%)
Cough	5/151 (3.3%)		2/151 (1.3%)
Nasal discomfort	3/151 (2%)		1/151 (0.7%)
Nasal septum ulceration	0/151 (0%)		4/151 (2.6%)
Nasal dryness	1/151 (0.7%)		2/151 (1.3%)
Asthma	0/151 (0%)		2/151 (1.3%)
Dry throat	0/151 (0%)		2/151 (1.3%)
Nasal oedema	2/151 (1.3%)		0/151 (0%)
Nasal ulcer	0/151 (0%)		2/151 (1.3%)
Rhinorrhoea	0/151 (0%)		2/151 (1.3%)
Dyspnoea	0/151 (0%)		1/151 (0.7%)
Dyspnoea exertional	0/151 (0%)		1/151 (0.7%)
Nasal polyps	1/151 (0.7%)		0/151 (0%)
Postnasal drip	0/151 (0%)		1/151 (0.7%)
Rhinalgia	1/151 (0.7%)		0/151 (0%)
Throat irritation	0/151 (0%)		1/151 (0.7%)
Wheezing	0/151 (0%)		1/151 (0.7%)
Skin and subcutaneous tissue disorders
Scab	1/151 (0.7%)		4/151 (2.6%)
Rash	3/151 (2%)		0/151 (0%)
Dermatitis allergic	0/151 (0%)		1/151 (0.7%)
Onychoclasis	0/151 (0%)		1/151 (0.7%)
Pain of skin	1/151 (0.7%)		0/151 (0%)
Pruritus generalised	0/151 (0%)		1/151 (0.7%)
Urticaria	1/151 (0.7%)		0/151 (0%)
Vascular disorders
Hypertension	0/151 (0%)		2/151 (1.3%)

Limitations/Caveats

[Not Specified]

More Information

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.

Results Point of Contact

Name/Title	GSK Response Center
Organization	GlaxoSmithKline
Phone	866-435-7343
Email

Responsible Party:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00289198

Other Study ID Numbers:

FFR106080

First Posted:

Feb 9, 2006

Last Update Posted:

Apr 13, 2018

Last Verified:

Sep 1, 2017