NCT01782326

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

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).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 3,362 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Type	Name	Description
DRUG	QVA149	QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI.
DRUG	Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)	Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.

Timeline

• Start date: 2013-07-01
• Primary completion: 2015-09-01
• Completion: 2015-09-01
• First posted: 2013-02-01
• Last updated: 2016-05-16
• Results posted: 2016-05-16

Locations

499 sites across 43 countries: Argentina, Austria, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Guatemala, Hong Kong, Hungary, Iceland, India, Italy, Japan, Latvia, Lithuania, Mexico, Netherlands, Norway, Philippines, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Thailand, Turkey (Türkiye), United Kingdom