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

Phase 3

Completed

• Conditions: Bronchial Asthma
• Interventions: Drug: GW815SF HFA MDI; Drug: salmeterol and fluticasone propionate

• Registration Number: NCT00448435
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-03-14
• Study First Submitted QC: 2007-03-15
• Study First Posted: 2007-03-16
• Study Start: 2007-04
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Results First Submitted: 2009-01-19
• Results First Submitted QC: 2009-06-25
• Results First Posted: 2009-08-11
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-03
• Last Update Posted: 2010-06-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
SLM+FP First	GW815SF HFA MDI	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).
SLM+FP First	salmeterol and fluticasone propionate	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).
SFC First	GW815SF HFA MDI	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).
SFC First	salmeterol and fluticasone propionate	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).
SFC	GW815SF HFA MDI	SFC (salmeterol/fluticasone propionate combination) 25/50mcg twice daily in Extension period (after cross-over period).

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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
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
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.
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.
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).
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).
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).
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).
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).
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).
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).

Trial Locations

Locations (1)

GSK Investigational Site; 🇯🇵 Tokyo, Japan