At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 581 enrolled
Drug / intervention
Indacaterol +1 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.
A Randomized, Double-blind, Parallel-group, 26-week Study Comparing the Efficacy and Safety of Indacaterol (Onbrez® Breezhaler® 150 mcg o.d.) With Salmeterol/Fluticasone Propionate (Seretide® Accuhaler® 50 mcg/500 mcg b.i.d.) in Patients With Moderate Chronic Obstructive Pulmonary Disease
In Brief
A Phase 4 clinical trial evaluating Indacaterol and Salmeterol for Chronic Obstructive Pulmonary Disease. Completed, enrolled 581 participants across 94 sites in 9 countries.
Detailed Summary
The purpose of this study is to compare the effectiveness and safety of indacaterol with salmeterol /fluticasone propionate treatment in patients with moderate chronic obstructive pulmonary disease who, on entry to the study are being treated with salmeterol /fluticasone propionate.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesArgentina, Colombia, Italy, Malaysia, Mexico, Netherlands, Spain, Switzerland, United Kingdom
Collaborators--
Timeline
Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartFeb 2012
First PostedMar 2012
Primary CompletionFeb 2014
TodayJul 2026
First PostedMar 15, 2012
Enrollment StartFeb 1, 2012
Primary CompletionFeb 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 14.3 years ago
Interventions
Indacateroldrug
Indacaterol is delivered via a SDDPI.
Salmeteroldrug
Salmeterol/fluticasone is delivered via a MDDPI