CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 805 enrolled
Drug / intervention
Indacaterol 300 μg +3 moredrug
Likely dose
Indacaterol 300 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/NCT00529529
NCT00529529Phase 3Completed
CompareCT.gov

A 26-week Treatment, Randomized, Multicenter, Double-blind, Double-dummy, Parallel-group Study to Assess the Safety of Indacaterol (300 and 600 µg o.d.) in Patients With Moderate to Severe Persistent Asthma, Using Salmeterol (50 µg b.i.d.) as an Active Control

Novartis Pharmaceuticals·interventional·Posted Sep 14, 2007·Updated Aug 29, 2011

In Brief

A Phase 3 clinical trial evaluating Indacaterol 300 μg, Salmeterol 50 μg, and 2 other interventions for Asthma. Completed, enrolled 805 participants across 126 sites in 12 countries.

Detailed Summary

This study was designed to assess the safety of indacaterol (300 µg and 600 µg (2 x 300 μg capsules) once daily \[od\]), compared with salmeterol (50 μg twice a day \[b.i.d.\]), over 26 weeks, in patients with moderate to severe persistent asthma.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesArgentina, Canada, Czechia, France, Germany, Hungary, Italy, Peru, Slovakia, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 14, 2007
Enrollment StartSep 1, 2007
Primary CompletionAug 1, 2008
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 18.8 years ago

Interventions

Indacaterol 300 μgdrug

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

Salmeterol 50 μgdrug

Salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.

Placebo to indacateroldrug

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

Placebo to salmeteroldrug

Placebo to salmeterol was supplied as powder filled capsules together with the manufacturer's proprietary dry powder inhalation device.