At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 416 enrolled
Drug / intervention
Indacaterol 150 μg +1 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 12-week Treatment, Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Indacaterol (150 μg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
In Brief
A Phase 3 clinical trial evaluating Indacaterol 150 μg and Placebo to indacaterol for Chronic Obstructive Pulmonary Disease. Completed, enrolled 416 participants across 120 sites in 3 countries.
Detailed Summary
This study was designed to provide 12 weeks efficacy and safety data of the 150 μg once-daily (od) dose of indacaterol in chronic obstructive pulmonary disease (COPD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesBelgium, New Zealand, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartFeb 2008
First PostedFeb 2008
Primary CompletionJul 2008
TodayJul 2026
First PostedFeb 27, 2008
Enrollment StartFeb 1, 2008
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 18.3 years ago
Interventions
Indacaterol 150 μgdrug
Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Placebo to indacateroldrug
Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.