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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
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.
Details
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 51 |
| Start date | 2007-04 |
| Completion | 2008-01 |
Conditions
- Bronchial Asthma
Interventions
- GW815SF HFA MDI
- salmeterol and fluticasone propionate
Primary outcomes
- 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 \[Weeks 1-4/Weeks 7-10\]).
Countries
Japan