At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 449 enrolled
Drug / intervention
NVA237 50 µg and indacaterol 150 µg +1 moredrug
Likely dose
NVA237 50 µg and indacaterol 150 µgfrom 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 12-week Multi-center, Randomized, Double-blind, Parallel Group Study to Assess the Efficacy, Safety and Tolerability of the Co-administration of NVA237 + Indacaterol Once Daily vs. Indacaterol Once Daily in Patients With Moderate to Severe COPD
In Brief
A Phase 3 clinical trial evaluating NVA237 50 µg and indacaterol 150 µg and Placebo to NVA237 and indacaterol 150 µg for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 449 participants across 80 sites in 10 countries.
Detailed Summary
This study assessed the efficacy, safety and tolerability of the co-administration of NVA237 plus indacaterol taken once daily versus indacaterol taken once daily in patients with moderate to severe Chronic Obstructive Pulmonary Disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesBelgium, Bulgaria, Greece, Hungary, Ireland, Russia, Slovakia, Spain, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartMay 2012
First PostedMay 2012
Primary CompletionJan 2013
TodayJul 2026
First PostedMay 23, 2012
Enrollment StartMay 1, 2012
Primary CompletionJan 1, 2013
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.1 years ago
Interventions
NVA237 50 µg and indacaterol 150 µgdrug
NVA237 50 µg and indacaterol 150 µg supplied as blistered capsules for inhalation.
Placebo to NVA237 and indacaterol 150 µgdrug
Placebo to NVA237 and indacaterol 150 µg supplied as blistered capsules for inhalation.