CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,598 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.

Search/NCT00900731
NCT00900731Phase 3Completed
CompareCT.gov

A 12-week Treatment, Multicenter, Randomized, Parallel-group, Blinded, Double-dummy Study to Compare the Efficacy and Safety of Indacaterol (150 µg Once Daily [od]) Delivered Via a Single Dose Dry Powder Inhaler (SDDPI) With Tiotropium (18 µg od) Delivered Via a HandiHaler®, in Patients With Moderate-to-severe COPD

Novartis Pharmaceuticals·interventional·Posted May 13, 2009·Updated Aug 19, 2011

In Brief

A Phase 3 clinical trial evaluating Indacaterol 150 μg, Tiotropium 18 μg, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 1,598 participants across 212 sites in 22 countries.

Detailed Summary

This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesAustria, Belgium, Canada, Colombia, Denmark, Finland, France, Germany, Greece, Hungary, Israel, Italy, Mexico, Norway, Poland, Russia, Slovakia, Spain, Switzerland, Turkey (Türkiye), United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 13, 2009
Enrollment StartJun 1, 2009
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.1 years ago

Interventions

Indacaterol 150 μgdrug

Indacaterol 150 μg was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Tiotropium 18 μgdrug

Tiotropium 18 μg was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).

Placebo to indacateroldrug

Placebo to indacaterol was provided in powder filled capsules with a single dose dry powder inhaler (SDDPI).

Placebo to tiotropiumdrug

Placebo to tiotropium was provided in powder filled capsules with the manufacturer's proprietary inhalation device (HandiHaler®).