At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 2,144 enrolled
Drug / intervention
indacaterol and glycopyrronium (QVA149) +4 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 26-week Treatment Multi-center, Randomized, Double-blind, Parallel-group, Placebo and Active Controlled (Open Label) Study to Assess the Efficacy, Safety and Tolerability of QVA149 (110/50 μg q.d.) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
In Brief
A Phase 3 clinical trial evaluating indacaterol and glycopyrronium (QVA149), glycopyrronium (NVA237), and 3 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 2,144 participants across 166 sites in 19 countries.
Detailed Summary
The purpose of this study is to provide pivotal efficacy and safety data for QVA149 in patients with moderate to severe COPD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Bulgaria, Canada, France, Germany, Guatemala, Hungary, Japan, Philippines, Poland, Russia, Slovakia, South Africa, Spain, Switzerland, Taiwan, Turkey (Türkiye), United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartSep 2010
First PostedSep 2010
Primary CompletionFeb 2012
Study CompletionMar 2012
TodayJul 2026
First PostedSep 15, 2010
Enrollment StartSep 1, 2010
Primary CompletionFeb 1, 2012
Study CompletionMar 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 15.8 years ago
Interventions
indacaterol and glycopyrronium (QVA149)drug
Capsules for inhalation delivered via SDDPI.
glycopyrronium (NVA237)drug
Capsules for inhalation delivered via SDDPI.
indacaterol (QAB149)drug
Capsules for inhalation delivered via SDDPI.
tiotropiumdrug
Capsules for inhalation delivered via HandiHaler® device.
placebodrug
Placebo to match capsules for inhalation delivered via SDDPI.