CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,142 enrolled
Drug / intervention
Indacaterol 150 μg +2 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.

Search/NCT00877383
NCT00877383Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

Novartis Pharmaceuticals·interventional·Posted Apr 7, 2009·Updated Aug 25, 2011

In Brief

A Phase 3 clinical trial evaluating Indacaterol 150 μg, Tiotropium 18 μg, and 1 other intervention for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 1,142 participants across 176 sites in 9 countries.

Detailed Summary

This study assessed the efficacy and safety of indacaterol (150 µg once daily \[od\]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesCanada, Colombia, Czechia, Hungary, India, Netherlands, Slovakia, Spain, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 7, 2009
Enrollment StartApr 1, 2009
Primary CompletionFeb 1, 2010
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 17.2 years ago

Interventions

Indacaterol 150 μgdrug

Indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Tiotropium 18 μgdrug

Tiotropium was supplied in powder filled capsules together with the manufacturer's proprietary inhalation device (HandiHaler®).

Placebo to indacateroldrug

Placebo to indacaterol was supplied in powder filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.