Last reviewed · How we verify
A Randomized, Double-blind, Active-controlled, Parallel Group, Stratified, Multi-center, 12-week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm) 100/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI) With the Administration of Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent & Adult Patients With Mild to Moderate Asthma
To compare the efficacy and safety of the fixed combination asthma drug Flutiform HFA MDI with its two components administered alone, fluticasone propionate and formoterol fumarate, in adult and adolescent patients with mild to moderate asthma.
Details
| Lead sponsor | SkyePharma AG |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 357 |
| Start date | 2006-06 |
| Completion | 2008-02 |
Conditions
- Asthma
Interventions
- Fluticasone propionate/Formoterol Fumarate 100/10
- Fluticasone propionate 100
- Formoterol fumarate 10
Primary outcomes
- Change in Forced Expiratory volume in 1 s (FEV-1) from morning predose at Baseline (Week 0) to predose at Week 12 — Week 0 and 12
Countries
United States, Canada