CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,732 enrolled
Drug / intervention
Indacaterol +3 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.

Search/NCT00393458
NCT00393458Phase 3Completed
CompareCT.gov

A 52-week Treatment, Multicenter, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of Indacaterol (300 and 600 µg Once Daily) in Patients With Chronic Obstructive Pulmonary Disease, Using Formoterol (12 µg Twice Daily) as an Active Control

Novartis·interventional·Posted Oct 27, 2006·Updated Aug 18, 2011

In Brief

A Phase 3 clinical trial evaluating Indacaterol, Formoterol, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 1,732 participants across 183 sites in 25 countries.

Detailed Summary

This study was designed to assess the efficacy and long-term safety of 300 and 600 µg doses of indacaterol when delivered via a single-dose dry-powder inhaler (SDDPI) in patients with chronic obstructive pulmonary disease (COPD). Patients were randomized to receive either indacaterol 300 µg once daily, indacaterol 600 µg once daily, formoterol 12 µg twice daily, or placebo.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesArgentina, Chile, Colombia, Czechia, Denmark, Ecuador, Egypt, Estonia, France, Germany, Hungary, Israel, Italy, Latvia, Lithuania, Netherlands, Peru, Romania, Russia, Slovakia, South Korea, Spain, Switzerland, Turkey (Türkiye), United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 27, 2006
Enrollment StartOct 1, 2006
Primary CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 19.7 years ago

Interventions

Indacateroldrug

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

Formoteroldrug

Formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).

Placebo to indacateroldrug

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

Placebo to formoteroldrug

Placebo to formoterol was supplied in powder-filled capsules with the manufacturer's proprietary inhalation device (Aerolizer®).