At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 415 enrolled
Drug / intervention
Indacaterol +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 26-week Extension to a 26-week Treatment, Multicenter, Randomized, Double-blind, Placebo-controlled, Adaptive, Seamless, Parallel-group Study to Assess Safety, Tolerability and Efficacy of Two Doses of Indacaterol (150 and 300 µg o.d.) in Patients With Chronic Obstructive Pulmonary Disease
In Brief
A Phase 3 clinical trial evaluating Indacaterol and Placebo for COPD. Completed, enrolled 415 participants across 190 sites in 9 countries.
Detailed Summary
This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCOPD
CountriesArgentina, Canada, Germany, India, Italy, Spain, Sweden, Turkey (Türkiye), United States
Collaborators--
Timeline
Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2008
First PostedMay 2008
Primary CompletionMar 2009
TodayJul 2026
First PostedMay 15, 2008
Enrollment StartMay 1, 2008
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 18.1 years ago
Interventions
Indacateroldrug
Indacaterol once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)
Placebodrug
Placebo once-daily (o.d.) via single-dose dry-powder inhaler (SDDPI)