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Clinical trial

QVA vs. Salmeterol/Fluticasone, 52-week Exacerbation Study, FLAME (EFfect of Indacaterol Glycopyronium Vs Fluticasone Salmeterol on COPD Exacerbations)

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Last updated:1st Jul 2013

This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.


Study Type: Interventional
Allocation: Randomized
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).
Enrollment: 3362
Study Start Date: July 2013
Study Completion Date: September 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
QVA149
- Active Comparator: Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)


Related journal: Indacaterol–Glycopyrronium versus Salmeterol–Fluticasone for COPD

Category Value
Study start date 2013-07-01

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