At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 3,439 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 Phase IIIb Multicenter, 52 Week Treatment, Randomized, Blinded, Double Dummy, Parallel Group Efficacy Study Comparing the Effect of Inhaled Indacaterol 150 µg o.d. vs Inhaled Tiotropium 18 µg o.d. on Lung Function, Rate of Exacerbations and Related Outcomes in Patients With COPD
In Brief
A Phase 3 clinical trial evaluating Indacaterol 150 µg and Tiotropium for Chronic Obstructive Pulmonary Disease. Completed, enrolled 3,439 participants across 423 sites in 40 countries.
Detailed Summary
This study compares indacaterol with tiotropium in terms of bronchodilation over 52 weeks
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Costa Rica, Czechia, Denmark, Estonia, Finland, France, Germany, Hungary, Iceland, India, Israel, Italy, Latvia, Lithuania, Mexico, Netherlands, Peru, Philippines, Poland, Portugal, Romania, Russia, Slovakia, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey (Türkiye), United Kingdom, Venezuela
Collaborators--
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2009
Enrollment StartMar 2009
Primary CompletionJul 2012
TodayJul 2026
First PostedFeb 18, 2009
Enrollment StartMar 1, 2009
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 17.4 years ago
Interventions
Indacaterol 150 µgdrug
Indacaterol 150 µg o.d. delivered via SDDPI
Tiotropiumdrug
Tiotropium 18 µg o.d. delivered via handihaler®