At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,362 enrolled
Drug / intervention
QVA149 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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).
In Brief
A Phase 3 clinical trial evaluating QVA149 and Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS) for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 3,362 participants across 499 sites in 43 countries.
Detailed Summary
This study will assess the efficacy, safety and tolerability of QVA149 in patients with moderate to very severe COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, 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
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartJul 2013
Primary CompletionSep 2015
TodayJul 2026
First PostedFeb 1, 2013
Enrollment StartJul 1, 2013
Primary CompletionSep 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 13.4 years ago
Interventions
QVA149drug
QVA149 will be supplied in a capsule form in blister packs for use in the Novartis Concept 1 SDDPI.
Long acting B2 agonist (LABA) and inhaled corticosteroid (ICS)drug
Salmeterol/fluticasone dry inhalation powder delivered via the Accuhaler device.