Last reviewed · How we verify
A Randomized, Double-blind, Active-controlled, Parallel Group, Stratified, Multi-center, 12-Week Study Comparing the Safety and Efficacy of Fluticasone and Formoterol Combination (FlutiForm™ 250/10ug Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Fluticasone (250ug Twice Daily) Alone in SkyePharma HFA pMDI and Flovent® HFA pMDI in Adolescent and Adult Patients With Moderate to Severe Asthma
The medications being used in this study are individually approved by the Food and Drug Administration (FDA). The medication under investigation is a combination of two medications in one inhaler. The purpose of this study is to determine how well your asthma is controlled when taking one of the three treatment.
Details
| Lead sponsor | SkyePharma AG |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 438 |
| Start date | 2008-03 |
| Completion | 2008-10 |
Conditions
- Asthma
Interventions
- FlutiForm 250/10
- SKP-Fluticasone
- Flovent Fluticasone HFA
Primary outcomes
- To demonstrate the efficacy in terms of the Formoterol fumarate component of SKP FlutiForm HFA pMDI (250/10ug) compared to SKP Fluticasone HFA pMDI (250ug), on the change in FEV1 from morning pre-dose at Baseline (Week 0) to 2 hours post-dose at Week 12. — Week 0 and 12 visits
Countries
United States, Argentina, Chile, Hungary, Mexico, Peru, Poland, Romania, South Africa, Ukraine