Trial Outcomes & Findings for Clinical Assessment Of GW815SF HFA MDI In Pediatric Patients With Bronchial Asthma (NCT NCT00448435)

NCT ID: NCT00448435

Last Updated: 2010-06-08

Results Overview

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 \[Weeks 1-4/Weeks 7-10\]).

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 51 participants
• Primary outcome timeframe: Crossover Period Weeks 1-4, and 7-10
• Results posted on: 2010-06-08

Participant Flow

Participant milestones

Measure	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).
Treatment Period I - 4 Weeks STARTED	26	25
Treatment Period I - 4 Weeks COMPLETED	26	25
Treatment Period I - 4 Weeks NOT COMPLETED	0	0
Washout Period - 2 Weeks STARTED	26	25
Washout Period - 2 Weeks COMPLETED	25	25
Washout Period - 2 Weeks NOT COMPLETED	1	0
Treatment Period II - 4 Weeks STARTED	25	25
Treatment Period II - 4 Weeks COMPLETED	25	25
Treatment Period II - 4 Weeks NOT COMPLETED	0	0
Extension Period - 20 Weeks STARTED	50	0
Extension Period - 20 Weeks COMPLETED	50	0
Extension Period - 20 Weeks NOT COMPLETED	0	0

Reasons for withdrawal

Measure	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).
Washout Period - 2 Weeks Withdrawal by Subject	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Overall Study Population n=51 Participants Randomized Population
Age Continuous	8.3 Years STANDARD_DEVIATION 2.41 • n=93 Participants
Sex: Female, Male Female	17 Participants n=93 Participants
Sex: Female, Male Male	34 Participants n=93 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	51 Participants n=93 Participants
Region of Enrollment Japan	51 participants n=93 Participants

PRIMARY outcome

Timeframe: Crossover Period Weeks 1-4, and 7-10

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

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]).

Outcome measures

Measure	SFC 50/100 Mcg/Day n=48 Participants 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 n=48 Participants Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Adjusted Mean Change From Baseline in Morning PEF (Peak Expiratory Flow) During the 4-week Treatment Periods	14.3 Liters/minute Standard Error 4.53	17.1 Liters/minute Standard Error 4.53

SECONDARY outcome

Timeframe: Crossover Period Weeks 1-4, 7-10

Population: PPS

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.

Outcome measures

Measure	SFC 50/100 Mcg/Day n=48 Participants 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 n=48 Participants Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 4-week Treatment Periods	5.38 Percentage of predicted value Standard Error 1.543	6.73 Percentage of predicted value Standard Error 1.543

SECONDARY outcome

Timeframe: Crossover Period weeks 1-4, 7-10

Population: PPS

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.

Outcome measures

Measure	SFC 50/100 Mcg/Day n=48 Participants 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 n=48 Participants Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 4-week Treatment Periods	5.01 Percentage of personal best value Standard Error 1.480	6.46 Percentage of personal best value Standard Error 1.480

SECONDARY outcome

Timeframe: Crossover Period weeks 1-4, 7-10

Population: PPS

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.

Outcome measures

Measure	SFC 50/100 Mcg/Day n=48 Participants 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 n=48 Participants Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Adjusted Mean Change From Baseline in Evening PEF During the 4-week Treatment Periods	16.3 L/min Standard Error 3.74	15.8 L/min Standard Error 3.74

SECONDARY outcome

Timeframe: Crossover Period Weeks 1-4, 7-10

Population: PPS

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.

Outcome measures

Measure	SFC 50/100 Mcg/Day n=48 Participants 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 n=48 Participants Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Adjusted Mean Change From Baseline of Circadian Variation in Morning PEF(%) During the 4-week Treatment Periods	0.06 Percentage of circadian variation Standard Error 0.638	-0.08 Percentage of circadian variation Standard Error 0.638

SECONDARY outcome

Timeframe: Crossover Period Week 1-4, 7-10

Population: PPS

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

Outcome measures

Measure	SFC 50/100 Mcg/Day n=48 Participants 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 n=48 Participants Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Percentage of Subjects With Symptom-Free Nights & Days Baseline	72.9 Percent of participants	81.3 Percent of participants
Percentage of Subjects With Symptom-Free Nights & Days After 4 Weeks of Treatment	91.7 Percent of participants	81.3 Percent of participants

SECONDARY outcome

Timeframe: Crossover Period Weeks 1-4, 7-10

Population: PPS

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

Outcome measures

Measure	SFC 50/100 Mcg/Day n=48 Participants 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 n=48 Participants Per Protocol Set who received SLM (Salmeterol) DPI (Dry Powder Inhaler) 25 mcg +FP (Fluticasone Propionate) DPI 50 mcg twice daily
Percentage of Subjects With Rescue Medication-Free Nights and Days Baseline	87.5 Percentage of participants	87.5 Percentage of participants
Percentage of Subjects With Rescue Medication-Free Nights and Days After 4 Weeks of Treatment	93.8 Percentage of participants	87.5 Percentage of participants

SECONDARY outcome

Timeframe: Extension Period Weeks 11-30

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

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).

Outcome measures

Measure	SFC 50/100 Mcg/Day n=50 Participants 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
Adjusted Mean Change From Baseline in Morning PEF During the 20-week Extension Treatment Period	3.0 L/min Standard Deviation 24.56	—

SECONDARY outcome

Timeframe: Extension Period weeks 11-30

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

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).

Outcome measures

Measure	SFC 50/100 Mcg/Day n=50 Participants 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
Adjusted Mean Change From Baseline in Percent Predicted Morning PEF(%) During the 20-Week Extension Treatment Period	1.46 Percentage of predicted value Standard Deviation 9.568	—

SECONDARY outcome

Timeframe: Extension Period weeks 11-30

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

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).

Outcome measures

Measure	SFC 50/100 Mcg/Day n=50 Participants 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
Adjusted Mean Change From Baseline in Percent Personal Best Morning PEF(%) During the 20-week Extension Treatment Period	1.29 Percentage of personal best value Standard Deviation 8.541	—

SECONDARY outcome

Timeframe: Extension Period weeks 11-30

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

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).

Outcome measures

Measure	SFC 50/100 Mcg/Day n=50 Participants 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
Adjusted Mean Change From Baseline in Evening PEF During the 20-week Extension Treatment Period	2.7 L/Min Standard Deviation 23.43	—

SECONDARY outcome

Timeframe: Extension Period weeks 11-30

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

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).

Outcome measures

Measure	SFC 50/100 Mcg/Day n=50 Participants 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
Adjusted Mean Change From Baseline of Circadian Variation in PEF(%) During the 20-Week Extension Treatment Period	-0.37 Percentage of circadian variation Standard Deviation 3.568	—

SECONDARY outcome

Timeframe: Extension Period Weeks 11-30

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

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

Outcome measures

Measure	SFC 50/100 Mcg/Day n=50 Participants 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
Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment Baseline	84.0 Percentage of participants	—
Percentage of Subjects With Symptom-Free Nights & Days After 20 Weeks of Treatment After 20 weeks of treatment (at week 30)	84.8 Percentage of participants	—

SECONDARY outcome

Timeframe: Extension Period Weeks 11-30

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

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

Outcome measures

Measure	SFC 50/100 Mcg/Day n=50 Participants 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
Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment Baseline	90.0 Percentage of participants	—
Percentage of Subjects With Rescue Medication-Free Nights & Days After 20 Weeks of Treatment After 20 weeks of treatment (at week 30)	89.1 Percentage of participants	—

Adverse Events

SFC 50/100 Mcg/Day

Serious events: 0 serious events

Other events: 12 other events

Deaths: 0 deaths

SLM 50 + FP 100 Mcg/Day

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

SFC 50/100mcg/Day (Extension Period)

Serious events: 0 serious events

Other events: 35 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	SFC 50/100 Mcg/Day n=51 participants at risk 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	SLM 50 + FP 100 Mcg/Day n=50 participants at risk 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	SFC 50/100mcg/Day (Extension Period) n=51 participants at risk Safety Population who switched to Extension Period and received GW815SF HFA MDI 25/50mcg twice daily during the Extension period
Respiratory, thoracic and mediastinal disorders Upper Respiratory Tract inflammation	13.7% 7/51	6.0% 3/50	34.0% 17/50
Infections and infestations Nasopharyngitis	3.9% 2/51	8.0% 4/50	14.0% 7/50
Infections and infestations Gastroenteritis	2.0% 1/51	4.0% 2/50	14.0% 7/50
Respiratory, thoracic and mediastinal disorders Asthma	2.0% 1/51	2.0% 1/50	10.0% 5/50
Skin and subcutaneous tissue disorders Eczema	0.00% 0/51	0.00% 0/50	8.0% 4/50
Gastrointestinal disorders Stomatitis	3.9% 2/51	0.00% 0/50	6.0% 3/50

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

• Principal investigator is a sponsor employee 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.
• Publication restrictions are in place

Restriction type: OTHER