Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00448435
• Collaborator: (none)
• Enrollment: 51
• Locations: 8
• Arms: 3
• Duration (Months): 9
• Patients Per Site: 6.4
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

To evaluate the efficacy and safety of GW815SF HFA MDI 25/50µg 1 inhalation bid in comparison with concomitant treatment with salmeterol xinafoate DPI 25µg 1 inhalation bid plus fluticasone propionate DPI 50µg 1 inhalation bid in paediatric patients with asthma.

To evaluate the safety of long-term treatment of GW815SF HFA MDI 25/50µg 1 inhalation bid in paediatric patients with asthma.

Condition or Disease	Intervention/Treatment	Phase
Bronchial Asthma	Drug: GW815SF HFA MDI; Drug: salmeterol and fluticasone propionate	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 51 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Study to Compare GW815SF HFA MDI With Concomitant Treatment With Salmeterol Xinafoate DPI Plus Fluticasone Propionate DPI and to Assess Long-term Safety of GW815SF HFA MDI
• Study Start Date: Apr 1, 2007
• Actual Primary Completion Date: Jan 1, 2008
• Actual Study Completion Date: Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SLM+FP First SLM(salmeterol) 25mcg + FP(fluticasone propionate) 50mcg twice daily in first intervention period and SFC(salmeterol/fluticasone propionate) 25/50mcg twice daily in second intervention period and (after washout period).	Drug: GW815SF HFA MDI; salmeterol and fluticasone propionate combination; Other Names: salmeterol/fluticasone propionate combination ; Drug: salmeterol and fluticasone propionate; salmeterol + fluticasone propionate
Active Comparator: SFC First SFC (Salmeterol/Fluticasone propionate combination) 25/50mcg twice daily in first intervention period and SLM (Salmeterol) 25mcg + FP (Fluticasone Propionate) 50mcg twice daily in second intervention period (after washout period).	Drug: GW815SF HFA MDI; salmeterol and fluticasone propionate combination; Other Names: salmeterol/fluticasone propionate combination ; Drug: salmeterol and fluticasone propionate; salmeterol + fluticasone propionate
Experimental: SFC SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).	Drug: GW815SF HFA MDI; salmeterol and fluticasone propionate combination; Other Names: salmeterol/fluticasone propionate combination

Outcome Measures

Primary Outcome Measures

1. Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods [Crossover Period Weeks 1-4, and 7-10]

   Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period [Weeks 1-4/Weeks 7-10]).

Secondary Outcome Measures

1. Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods [Crossover Period Weeks 1-4, 7-10]

   Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.

2. Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods [Crossover Period weeks 1-4, 7-10]

   Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.

3. Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods [Crossover Period weeks 1-4, 7-10]

   Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.

4. Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods [Crossover Period Weeks 1-4, 7-10]

   Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.

5. Percentage of Subjects With Symptom-Free Nights & Days [Crossover Period Week 1-4, 7-10]

   Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment

6. Percentage of Subjects With Rescue Medication-Free Nights and Days [Crossover Period Weeks 1-4, 7-10]

   Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment

7. Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period [Extension Period Weeks 11-30]

   Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30).

8. Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period [Extension Period weeks 11-30]

   Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).

9. Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period [Extension Period weeks 11-30]

   Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).

10. Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period [Extension Period weeks 11-30]

    Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).

11. Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period [Extension Period weeks 11-30]

    Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).

12. Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment [Extension Period Weeks 11-30]

    Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30).

13. Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment [Extension Period Weeks 11-30]

    Percentage of subjects with Rescue Medication Free Nights & Days after 20 weeks of Treatment (at week 30).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 5 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion criteria:

• Inclusion Criteria for Entry in Run-in Period

A pediatric patient already diagnosed as having bronchial asthma who meets all of the following criteria is eligible for the study:

• Male or female patients aged ≥5 and ≤14 years. Enrolment of a female patient of childbearing potential is allowed only if she is tested negative in the pregnancy testing at the start of Treatment Period 1 and if she agrees to undergo pregnancy testing at the protocol-specified timings and to take contraceptive measures without fail.

• Written informed consent must be obtained from a legally acceptable representative of the subject. Consent of the subject him/herself should also be obtained, wherever possible, after giving an explanation in an as easy to understand as possible manner.

• An outpatient who has been treated with ICS (FP 100μg/day or equivalent) for at least 4 weeks prior to Visit 1.

• Able to use a peak flow meter in a correct manner in the investigator's/subinvestigator's judgment.

• Able to use MDI and DPI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment.

Inclusion Criteria for Entry in Treatment Period 1 A subject will be randomized to one of the two treatment groups only if he/she has completed the run-in period and meets all the following criteria.

1. Has a mean of morning PEF measurements in the last 7 days of the run-in period (excluding the first day of Treatment Period 1) ≤90% of his/her best PEF measurement .

2. Was able to perform entry in the asthma diary and PEF measurements in a correct manner in the investigator's/subinvestigator's judgment.

3. Able to use MDI and DPI in a correct manner (with the assistance of his/her caregiver as necessary) in the investigator's/subinvestigator's judgment.

Exclusion criteria:

• Exclusion Criteria for Entry in Run-in Period

A patient who applies any of the following criteria is not eligible for the study:

• Admitted to the hospital due to asthma exacerbation within 8 weeks prior to Visit 1.

• Used systemic steroid within 4 weeks prior to Visit 1.

• Received antibacterials or antivirals for treatment of upper or lower respiratory tract infection within 2 weeks prior to Visit 1.

• Has a safety problem in participation in the study because of a serious, uncontrolled systemic disease including nervous system disorder.

• Has or is suspected to have deep-seated mycosis or infection to which no effective antibacterial agent is available.

• Has or is suspected to have hypersensitivity to the investigational product, rescue medication or any ingredients of them.

• Is pregnant or lactating, may be pregnant, or plans for pregnancy during the study period.

• Has received the last dose in another clinical study within 2 months prior to this study.

• Is not eligible for the study in the investigator's/subinvestigator's judgment.

Exclusion Criteria for Entry in Treatment Period 1

Enrolment of a subject completing the run-in period into Treatment Period 1 will not be allowed if any of the following applies:

1. Admitted to the hospital due to asthma exacerbation during the run-in period.

2. Had upper or lower respiratory tract infection during the 2 weeks just before Visit 2.

3. Used prohibited drugs during the 2 weeks just before Visit 2.

4. Is not eligible for the study in the investigator's/subinvestigator's judgment.

Exclusion Criteria for Entry in Treatment Period 2

Enrolment of a subject completing the washout period into Treatment Period 2 will not be allowed if any of the following applies:

1. Admitted to the hospital due to asthma exacerbation during the washout period.

2. Had upper or lower respiratory tract infection during the 2 weeks just before Visit 4.

3. Used prohibited drugs during the 2 weeks just before Visit 4.

4. Is not eligible for entry in Treatment Period 2 in the investigator's/subinvestigator's judgment.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Chiba		Japan	260-0001
2	GSK Investigational Site	Kanagawa		Japan	245-0018
3	GSK Investigational Site	Saitama		Japan	360-0018
4	GSK Investigational Site	Saitama		Japan	360-0812
5	GSK Investigational Site	Tokyo		Japan	154-0002
6	GSK Investigational Site	Tokyo		Japan	154-0017
7	GSK Investigational Site	Tokyo		Japan	158-0083
8	GSK Investigational Site	Tokyo		Japan	158-0097

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00448435
• Other Study ID Numbers: 110099
• First Posted: Mar 16, 2007
• Last Update Posted: Jun 8, 2010
• Last Verified: Jun 1, 2010

• Keywords provided by , ,: Salmeterol; Fluticasone propionate; Salmeterol/Fluticasone propionate combination; Pediatric bronchial asthma
• Additional relevant MeSH terms: Asthma; Fluticasone; Xhance; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination

Study Results

Participant Flow

Arm/Group Title	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
Arm/Group Description	GW815SF (SFC; Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in first intervention period and SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in second intervention period (after washout period).	SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily in first intervention period and GW815SF (SFC; Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in second intervention period (after washout period).
Period Title: Treatment Period I - 4 Weeks
STARTED	26	25
COMPLETED	26	25
NOT COMPLETED	0	0
Period Title: Treatment Period I - 4 Weeks
STARTED	26	25
COMPLETED	25	25
NOT COMPLETED	1	0
Period Title: Treatment Period I - 4 Weeks
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0
Period Title: Treatment Period I - 4 Weeks
STARTED	50	0
COMPLETED	50	0
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Overall Study Population
Arm/Group Description	Randomized Population
Overall Participants	51
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	8.3 (2.41)
Sex: Female, Male (Count of Participants)
Female	17 33.3%
Male	34 66.7%
Race/Ethnicity, Customized (Number) [Number]
Asian-Japanese Heritage	51 100%
Region of Enrollment (participants) [Number]
Japan	51 100%

Outcome Measures

1. Primary Outcome

Title	Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods
Description	Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out (i.e., the last 7 days prior to the day of starting treatment period [Weeks 1-4/Weeks 7-10]).
Time Frame	Crossover Period Weeks 1-4, and 7-10

Outcome Measure Data

Analysis Population Description

PPS (Per Protocol Set): randomized subjects less those who did not complete treatment.

Arm/Group Title	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Arm/Group Description	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Measure Participants	48	48
Mean (Standard Error) [Liters/minute]	14.3 (4.53)	17.1 (4.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	SFC 50/100 Mcg/Day, SLM 50 Mcg + FP 100 Mcg/Day
	Comments	Difference between treatments [(SLM + FP)- SFC](SE) 2.8 (5.91)
	Type of Statistical Test	Non-Inferiority or Equivalence
	Comments	Equivalence margin + or - 15 L/min
Statistical Test of Hypothesis	p-Value	0.6383
	Comments	Confidence Interval
	Method	Mixed Models Analysis
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Net)
	Estimated Value	2.8
	Confidence Interval	() 95%; -9.10 to 14.69
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 5.91
	Estimation Comments

2. Secondary Outcome

Title	Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods
Description	Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Time Frame	Crossover Period Weeks 1-4, 7-10

Outcome Measure Data

Analysis Population Description

PPS

Arm/Group Title	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Arm/Group Description	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Measure Participants	48	48
Mean (Standard Error) [Percentage of predicted value]	5.38 (1.543)	6.73 (1.543)

3. Secondary Outcome

Title	Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods
Description	Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Time Frame	Crossover Period weeks 1-4, 7-10

Outcome Measure Data

Analysis Population Description

PPS

Arm/Group Title	SFC 50/100 Mcg/Day	SLM 50mcg + FP 100 Mcg/Day
Arm/Group Description	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily
Measure Participants	48	48
Mean (Standard Error) [Percentage of personal best value]	5.01 (1.480)	6.46 (1.480)

4. Secondary Outcome

Title	Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods
Description	Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Time Frame	Crossover Period weeks 1-4, 7-10

Outcome Measure Data

Analysis Population Description

PPS

Arm/Group Title	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Arm/Group Description	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Measure Participants	48	48
Mean (Standard Error) [L/min]	16.3 (3.74)	15.8 (3.74)

5. Secondary Outcome

Title	Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods
Description	Mean change from baseline = value at each assessment period (mean of the values obtained at each assessment period [Weeks 1-4/Weeks 7-10]) minus baseline value. Baseline: Mean of the daily values over the last 7 days of the 2-week run-in/wash-out.
Time Frame	Crossover Period Weeks 1-4, 7-10

Outcome Measure Data

Analysis Population Description

PPS

Arm/Group Title	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Arm/Group Description	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Measure Participants	48	48
Mean (Standard Error) [Percentage of circadian variation]	0.06 (0.638)	-0.08 (0.638)

6. Secondary Outcome

Title	Percentage of Subjects With Symptom-Free Nights & Days
Description	Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment
Time Frame	Crossover Period Week 1-4, 7-10

Outcome Measure Data

Analysis Population Description

PPS

Arm/Group Title	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Arm/Group Description	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Measure Participants	48	48
Baseline	72.9 142.9%	81.3 NaN
After 4 Weeks of Treatment	91.7 179.8%	81.3 NaN

7. Secondary Outcome

Title	Percentage of Subjects With Rescue Medication-Free Nights and Days
Description	Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment
Time Frame	Crossover Period Weeks 1-4, 7-10

Outcome Measure Data

Analysis Population Description

PPS

Arm/Group Title	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Arm/Group Description	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Measure Participants	48	48
Baseline	87.5 171.6%	87.5 NaN
After 4 Weeks of Treatment	93.8 183.9%	87.5 NaN

8. Secondary Outcome

Title	Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period
Description	Mean change from baseline = value at assessment period (mean of the values obtained at assessment period (Weeks 11-30).) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting of the Extension period (Weeks 11-30).
Time Frame	Extension Period Weeks 11-30

Outcome Measure Data

Analysis Population Description

FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Arm/Group Title	SFC 50/100 Mcg/Day
Arm/Group Description	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Measure Participants	50
Mean (Standard Deviation) [L/min]	3.0 (24.56)

9. Secondary Outcome

Title	Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period
Description	Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Time Frame	Extension Period weeks 11-30

Outcome Measure Data

Analysis Population Description

FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Arm/Group Title	SFC 50/100 Mcg/Day
Arm/Group Description	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Measure Participants	50
Mean (Standard Deviation) [Percentage of predicted value]	1.46 (9.568)

10. Secondary Outcome

Title	Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period
Description	Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Time Frame	Extension Period weeks 11-30

Outcome Measure Data

Analysis Population Description

FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Arm/Group Title	SFC 50/100 Mcg/Day
Arm/Group Description	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Measure Participants	50
Mean (Standard Deviation) [Percentage of personal best value]	1.29 (8.541)

11. Secondary Outcome

Title	Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period
Description	Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Time Frame	Extension Period weeks 11-30

Outcome Measure Data

Analysis Population Description

FAS (Full Analysis Set) during the Exension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Arm/Group Title	SFC 50/100 Mcg/Day
Arm/Group Description	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Measure Participants	50
Mean (Standard Deviation) [L/Min]	2.7 (23.43)

12. Secondary Outcome

Title	Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period
Description	Mean change from baseline = value at assessment period (mean of the values obtained at assessment period [Weeks 11-30]) minus baseline value. Baseline: Mean of the daily values over the last 7 days prior to the day of starting the Extension period (Weeks 11-30).
Time Frame	Extension Period weeks 11-30

Outcome Measure Data

Analysis Population Description

FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Arm/Group Title	SFC 50/100 Mcg/Day
Arm/Group Description	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Measure Participants	50
Mean (Standard Deviation) [Percentage of circadian variation]	-0.37 (3.568)

13. Secondary Outcome

Title	Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment
Description	Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30).
Time Frame	Extension Period Weeks 11-30

Outcome Measure Data

Analysis Population Description

FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Arm/Group Title	SFC 50/100 Mcg/Day
Arm/Group Description	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Measure Participants	50
Baseline	84.0 164.7%
After 20 weeks of treatment (at week 30)	84.8 166.3%

14. Secondary Outcome

Title	Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment
Description	Percentage of subjects with Rescue Medication Free Nights & Days after 20 weeks of Treatment (at week 30).
Time Frame	Extension Period Weeks 11-30

Outcome Measure Data

Analysis Population Description

FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Arm/Group Title	SFC 50/100 Mcg/Day
Arm/Group Description	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
Measure Participants	50
Baseline	90.0 176.5%
After 20 weeks of treatment (at week 30)	89.1 174.7%

Adverse Events

Arm/Group Title	SFC 50/100 Mcg/Day		SLM 50 + FP 100 Mcg/Day		SFC 50/100mcg/Day (Extension Period)
Arm/Group Description	Safety Population who received GW815SF (SFC, Salmeterol/Fluticasone Propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10		Safety Population who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily in Crossover Period Weeks 1-4 and 7-10		Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period
All Cause Mortality
	SFC 50/100 Mcg/Day		SLM 50 + FP 100 Mcg/Day		SFC 50/100mcg/Day (Extension Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	SFC 50/100 Mcg/Day		SLM 50 + FP 100 Mcg/Day		SFC 50/100mcg/Day (Extension Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/51 (0%)		0/50 (0%)		0/51 (0%)
Other (Not Including Serious) Adverse Events
	SFC 50/100 Mcg/Day		SLM 50 + FP 100 Mcg/Day		SFC 50/100mcg/Day (Extension Period)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	12/51 (23.5%)		10/50 (20%)		35/51 (68.6%)
Gastrointestinal disorders
Stomatitis	2/51 (3.9%)		0/50 (0%)		3/50 (6%)
Infections and infestations
Nasopharyngitis	2/51 (3.9%)		4/50 (8%)		7/50 (14%)
Gastroenteritis	1/51 (2%)		2/50 (4%)		7/50 (14%)
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract inflammation	7/51 (13.7%)		3/50 (6%)		17/50 (34%)
Asthma	1/51 (2%)		1/50 (2%)		5/50 (10%)
Skin and subcutaneous tissue disorders
Eczema	0/51 (0%)		0/50 (0%)		4/50 (8%)

Limitations/Caveats

[Not Specified]

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Certain Agreements

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

GSK agreements may vary with individual investigators, but will not prohibit an 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 preceed the primary publication of the entire clinical trial.