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Assessment of the Efficacy and Safety of FlutiForm® pMDI 125/5 µg (2 Puffs Bid) Versus Symbicort® Turbohaler® 200/6 µg (2 Puffs Bid) in Adolescent and Adult Subjects With Moderate to Severe Persistent, Reversible Asthma
A comparator study to assess safety and efficacy of Flutiform® compared with symbicort turbohaler in asthma patients with moderate to severe persistent, reversible asthma.
Details
| Lead sponsor | Mundipharma Research Limited |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 261 |
| Start date | 2010-04 |
| Completion | 2011-07 |
Conditions
- Asthma
Interventions
- Flutiform
- Symbicort Turbohaler
Primary outcomes
- non-inferiority in the efficacy of FlutiForm® — baseline to the end of the 12 week treatment
To show non-inferiority in the efficacy of FlutiForm® pMDI 125/5 µg (2 puffs bid) vs Symbicort® Turbohaler® 200/6 µg (2 puffs bid), based on the mean change in the pre morning dose value of forced expiratory volume in the first second (FEV1) from baseline (end of run-in period) to the end of the 12 week treatment period.
Countries
Bulgaria, Hungary, India, Poland, Romania