QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.
Study Type: Interventional
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A 52-week Treatment, Multi-center, Randomized, Double-blind, Double Dummy, Parallel-group, Active Controlled Study to Compare the Effect of QVA149 (Indacaterol Maleate / Glycopyrronium Bromide) With Salmeterol/Fluticasone on the Rate of Exacerbations in Subjects With Moderate to Very Severe COPD. (FLAME).
Study Start Date: July 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
- Experimental: QVA149
- Active Comparator: Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)
Related journal: Indacaterol–Glycopyrronium versus Salmeterol–Fluticasone for COPD
|Study start date||2013-07-01|