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

Study Type:	Interventional
Study Design:	Randomized, Open Label, Crossover Assignment
Condition:	Bronchial Asthma
Interventions:	Drug: GW815SF HFA MDI Drug: salmeterol and fluticasone propionate

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

	Description
SFC 50/100 Mcg/Day First	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 50 Mcg + FP 100 Mcg/Day First	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).

	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
STARTED	26	25
COMPLETED	26	25
NOT COMPLETED	0	0

	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
STARTED	26	25
COMPLETED	25	25
NOT COMPLETED	1	0
Withdrawal by Subject	1	0

	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
STARTED	25	25
COMPLETED	25	25
NOT COMPLETED	0	0

	SFC 50/100 Mcg/Day First	SLM 50 Mcg + FP 100 Mcg/Day First
STARTED	50	0
COMPLETED	50	0
NOT COMPLETED	0	0

	Description
Overall Study Population	Randomized Population

	Overall Study Population
Number of Participants [units: participants]	51
Age [units: Years] Mean ± Standard Deviation	8.3 ± 2.41
Gender [units: participants]
Female	17
Male	34
Race/Ethnicity, Customized [units: Participants]
Asian-Japanese Heritage	51
Region of Enrollment [units: participants]
Japan	51

Outcome Measures

1. Primary:

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 ]

Measure Type	Primary
Measure Title	Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PPS (Per Protocol Set): randomized subjects less those who did not complete treatment.

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
SLM 50 Mcg + FP 100 Mcg/Day	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Number of Participants Analyzed [units: participants]	48	48
Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods [units: Liters/minute] Mean ± Standard Error	14.3 ± 4.53	17.1 ± 4.53

Statistical Analysis 1 for Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods

Groups ^[1]	All groups
Non-Inferiority/Equivalence Test ^[2]	Yes
Method ^[3]	Mixed Models Analysis
P Value ^[4]	0.6383
Mean Difference (Net) ^[5]	2.8
Standard Error of the mean	± 5.91
95% Confidence Interval	( -9.10 to 14.69 )

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Difference between treatments [(SLM + FP)- SFC](SE) 2.8 (5.91)
[2]	Details of power calculation, definition of non-inferiority margin, and other key parameters:
	Equivalence margin + or - 15 L/min
[3]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[4]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	Confidence Interval
[5]	Other relevant estimation information:
	No text entered.

2. Secondary:

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

Measure Type	Secondary
Measure Title	Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PPS

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
SLM 50 Mcg + FP 100 Mcg/Day	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Number of Participants Analyzed [units: participants]	48	48
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods [units: Percentage of predicted value] Mean ± Standard Error	5.38 ± 1.543	6.73 ± 1.543

No statistical analysis provided for Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods

3. Secondary:

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

Measure Type	Secondary
Measure Title	Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PPS

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
SLM 50mcg + FP 100 Mcg/Day	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg + FP (Fluticasone Propionate) DPI 50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day	SLM 50mcg + FP 100 Mcg/Day
Number of Participants Analyzed [units: participants]	48	48
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods [units: Percentage of personal best value] Mean ± Standard Error	5.01 ± 1.480	6.46 ± 1.480

No statistical analysis provided for Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods

4. Secondary:

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

Measure Type	Secondary
Measure Title	Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PPS

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
SLM 50 Mcg + FP 100 Mcg/Day	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Number of Participants Analyzed [units: participants]	48	48
Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods [units: L/min] Mean ± Standard Error	16.3 ± 3.74	15.8 ± 3.74

No statistical analysis provided for Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods

5. Secondary:

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

Measure Type	Secondary
Measure Title	Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PPS

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
SLM 50 Mcg + FP 100 Mcg/Day	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Number of Participants Analyzed [units: participants]	48	48
Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods [units: Percentage of circadian variation] Mean ± Standard Error	0.06 ± 0.638	-0.08 ± 0.638

No statistical analysis provided for Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods

6. Secondary:

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

Measure Type	Secondary
Measure Title	Percentage of Subjects With Symptom-Free Nights & Days
Measure Description	Percentage of subjects with Symptom Free Nights & Days after 4 weeks of Treatment
Time Frame	Crossover Period Week 1-4, 7-10
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PPS

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
SLM 50 Mcg + FP 100 Mcg/Day	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Number of Participants Analyzed [units: participants]	48	48
Percentage of Subjects With Symptom-Free Nights & Days [units: Percent of participants]
Baseline	72.9	81.3
After 4 Weeks of Treatment	91.7	81.3

No statistical analysis provided for Percentage of Subjects With Symptom-Free Nights & Days

7. Secondary:

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

Measure Type	Secondary
Measure Title	Percentage of Subjects With Rescue Medication-Free Nights and Days
Measure Description	Percentage of subjects with Rescue Medication Free Nights & Days after 4 weeks of Treatment
Time Frame	Crossover Period Weeks 1-4, 7-10
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
PPS

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Per Protocol Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily
SLM 50 Mcg + FP 100 Mcg/Day	Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day	SLM 50 Mcg + FP 100 Mcg/Day
Number of Participants Analyzed [units: participants]	48	48
Percentage of Subjects With Rescue Medication-Free Nights and Days [units: Percentage of participants]
Baseline	87.5	87.5
After 4 Weeks of Treatment	93.8	87.5

No statistical analysis provided for Percentage of Subjects With Rescue Medication-Free Nights and Days

8. Secondary:

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

Measure Type	Secondary
Measure Title	Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day
Number of Participants Analyzed [units: participants]	50
Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period [units: L/min] Mean ± Standard Deviation	3.0 ± 24.56

No statistical analysis provided for Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period

9. Secondary:

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

Measure Type	Secondary
Measure Title	Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day
Number of Participants Analyzed [units: participants]	50
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period [units: Percentage of predicted value] Mean ± Standard Deviation	1.46 ± 9.568

No statistical analysis provided for Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period

10. Secondary:

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

Measure Type	Secondary
Measure Title	Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day
Number of Participants Analyzed [units: participants]	50
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period [units: Percentage of personal best value] Mean ± Standard Deviation	1.29 ± 8.541

No statistical analysis provided for Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period

11. Secondary:

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

Measure Type	Secondary
Measure Title	Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Full Analysis Set) during the Exension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day
Number of Participants Analyzed [units: participants]	50
Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period [units: L/Min] Mean ± Standard Deviation	2.7 ± 23.43

No statistical analysis provided for Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period

12. Secondary:

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

Measure Type	Secondary
Measure Title	Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day
Number of Participants Analyzed [units: participants]	50
Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period [units: Percentage of circadian variation] Mean ± Standard Deviation	-0.37 ± 3.568

No statistical analysis provided for Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period

13. Secondary:

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

Measure Type	Secondary
Measure Title	Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment
Measure Description	Percentage of subjects with Symptom Free Nights & Days after 20 weeks of Treatment (at week 30).
Time Frame	Extension Period Weeks 11-30
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day
Number of Participants Analyzed [units: participants]	50
Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment [units: Percentage of participants]
Baseline	84.0
After 20 weeks of treatment (at week 30)	84.8

No statistical analysis provided for Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment

14. Secondary:

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

Measure Type	Secondary
Measure Title	Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment
Measure 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
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
FAS (Full Analysis Set) during the Extension period: all subjects switched to Extension period and received GW815SF HFA MDI.

Reporting Groups

	Description
SFC 50/100 Mcg/Day	Full Analysis Set who received GW815SF (SFC, Salmeterol/Fluticasone propionate combination) HFA (Hydro Fluoro Alkane) MDI (Metered Dose Inhaler) 25/50 mcg twice daily

Measured Values

	SFC 50/100 Mcg/Day
Number of Participants Analyzed [units: participants]	50
Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment [units: Percentage of participants]
Baseline	90.0
After 20 weeks of treatment (at week 30)	89.1

No statistical analysis provided for Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment

Responsible Party:	GSK ( Study Director )
Study ID Numbers:	110099
Study First Received:	March 14, 2007
Results First Received:	January 19, 2009
Last Updated:	October 30, 2009
ClinicalTrials.gov Identifier:	NCT00448435 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare