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A Multi-center, Randomized, Double-blind, Double Dummy, Placebo and Active Controlled Crossover Study, to Investigate the 24 Hour FEV1 Profile of a Single Dose of QMF TWISTHALER Device in Adult Patients With Persistent Asthma
This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using fluticasone/salmeterol as an active control.
Details
| Lead sponsor | Novartis |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 37 |
| Start date | 2007-11 |
| Completion | 2008-04 |
Conditions
- Asthma
Interventions
- fluticasone propionate/salmeterol
- indacaterol maleate / mometasone furoate
- placebo to indacaterol/mometasone
- placebo to fluticasone propionate/salmeterol
Primary outcomes
- Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) — Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was analyzed using Analysis of Covariance (ANCOVA) adjusting for treatment, period, sequence and center with period baseline as a covariate and patient nested within sequence as a random effect.
Countries
Belgium, Germany