CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 552 enrolled
Drug / intervention
Indacaterol +3 moredrug
Likely dose
Salmeterol 50 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/NCT01089127
NCT01089127Phase 3Completed
CompareCT.gov

A Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Different Doses of Indacaterol in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease, Using Salmeterol as an Active Control

Novartis Pharmaceuticals·interventional·Posted Mar 18, 2010·Updated Aug 19, 2011

In Brief

A Phase 3 clinical trial evaluating Indacaterol, Salmeterol 50 μg, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 552 participants across 69 sites.

Detailed Summary

This study compared the 14-day bronchodilator efficacy of indacaterol with that of placebo and salmeterol.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesUnited States
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2010
Enrollment StartMar 1, 2010
Primary CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 16.3 years ago

Interventions

Indacateroldrug

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

Salmeterol 50 μgdrug

Salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.

Placebo to indacateroldrug

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

Placebo to salmeteroldrug

Placebo to salmeterol was supplied in the manufacturer's proprietary Diskus inhaler device.