CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,123 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/NCT00821093
NCT00821093Phase 3Completed
CompareCT.gov

A 12 Week Treatment, Multi-center, Randomized, Parallel Group, Double Blind, Double Dummy Study to Assess the Superiority of Indacaterol (150 µg o.d.) Via a SDDPI in Patients With Moderate to Severe COPD, Using Salmeterol (50 µg b.i.d.) as an Active Comparator Delivered Via a DISKUS Inhaler

Novartis Pharmaceuticals·interventional·Posted Jan 13, 2009·Updated Aug 18, 2011

In Brief

A Phase 3 clinical trial evaluating Indacaterol 150 µg, Salmeterol 50 µg, and 2 other interventions for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 1,123 participants across 144 sites in 8 countries.

Detailed Summary

This study compared the safety and efficacy of indacaterol 150 µg taken once daily (o.d.) versus salmeterol 50 µg taken twice daily (b.i.d) in patients 40 years old or older with chronic obstructive pulmonary disease.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease (COPD)
CountriesCzechia, Germany, Hungary, India, Slovakia, Spain, Turkey (Türkiye), United States
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2009
Enrollment StartJan 1, 2009
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.5 years ago

Interventions

Indacaterol 150 µgdrug

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

Salmeterol 50 µgdrug

Salmeterol 50 μg was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]).

Placebo to indacateroldrug

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

Placebo to salmeteroldrug

Placebo to salmeterol was provided in the manufacturer's proprietary multi-dose dry-powder inhaler (MDDPI, \[DISKUS\]).