At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,002 enrolled
Drug / intervention
Indacaterol 150 μg +3 moredrug
Likely dose
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 26-week Treatment, Multi-center, Randomized, Double-blind, Double- Dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, and Safety of Indacaterol (150 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease, Using Salmeterol (50 µg b.i.d.) as an Active Control
In Brief
A Phase 3 clinical trial evaluating Indacaterol 150 μg, Salmeterol 50 μg, and 2 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 1,002 participants across 128 sites in 15 countries.
Detailed Summary
This study evaluated the safety and efficacy of 26 weeks treatment with indacaterol, placebo or salmeterol in patients with chronic obstructive pulmonary disease.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada, Colombia, Czechia, Denmark, Finland, France, Germany, Hungary, Iceland, India, Italy, Peru, Russia, Slovakia, Taiwan
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartNov 2007
First PostedDec 2007
Primary CompletionJan 2009
TodayJul 2026
First PostedDec 5, 2007
Enrollment StartNov 1, 2007
Primary CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 18.6 years ago
Interventions
Indacaterol 150 μgdrug
Indacaterol 150 μg once daily (o.d) inhaled
Salmeterol 50 μgdrug
Salmeterol 50 μg twice daily (b.i.d) delivered via a proprietary dry powder inhaler
Placebo to Indacateroldrug
Placebo to Indacaterol inhaled via SDDPI.
Placebo to Salmeteroldrug
Placebo to salmeterol delivered via a proprietary dry powder inhaler