Trials / Completed
CompletedNCT00393991
Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma
A Randomized, Double-blind, Placebo-controlled, Parallel, 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 Placebo or Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Mild to Moderate Asthma
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 475 (actual)
- Sponsor
- SkyePharma AG · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is 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, and with placebo in adult and adolescent patients with mild to moderate asthma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fluticasone propionate/formoterol fumarate 100/10 | FlutiForm 100/10ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation and 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks. |
| DRUG | Fluticasone propionate 100 | Fluticasone 100ug is a HFA pMDI that delivers 50ug of Fluticasone propionate per actuation. Patients will take 2 actuations BID for 12 weeks. |
| DRUG | Formoterol fumarate 10 | Formoterol 10ug is a HFA pMDI that delivers 5ug of Formoterol fumarate per actuation. Patients will take 2 actuations BID for 12 weeks. |
| DRUG | Placebo | Placebo is a HFA pMDI that delivers placebo aerosol. Patients will take 2 actuations BID for 12 weeks. |
Timeline
- Start date
- 2006-07-01
- Primary completion
- 2008-04-01
- Completion
- 2008-04-01
- First posted
- 2006-10-31
- Last updated
- 2011-06-23
Locations
57 sites across 2 countries: United States, Canada
Source: ClinicalTrials.gov record NCT00393991. Inclusion in this directory is not an endorsement.