At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 222 enrolled
Drug / intervention
Budesonide +3 moredrug
Likely dose
Budesonide 400 mcgfrom 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.
24-week Study to Evaluate Efficacy and Safety of the Combination Budesonide / Indacaterol vs Fluticasone / Salmeterol in Patients With COPD
In Brief
A Phase 4 clinical trial evaluating Budesonide, Fluticasone, and 2 other interventions for Chronic Obstructive Pulmonary Disease. Completed, enrolled 222 participants across 25 sites in 8 countries.
Detailed Summary
To demonstrate the free combination of budesonide and indacaterol is as efficacious as fluticasone and salmeterol in patients with COPD
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Obstructive Pulmonary Disease
CountriesArgentina, Brazil, Chile, Dominican Republic, Ecuador, Honduras, Mexico, Panama
Collaborators--
Timeline
Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedFeb 2014
Enrollment StartMay 2014
Primary CompletionJan 2016
TodayJul 2026
First PostedFeb 5, 2014
Enrollment StartMay 30, 2014
Primary CompletionJan 26, 2016
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 12.4 years ago
Interventions
Budesonidedrug
Budesonide 400 mcg twice a day via Breezhaler® device
Fluticasonedrug
Fluticasone 250 mcg twice daily via Accuhaler® device
Indacateroldrug
Indacaterol 150 mcg once daily via Breezhaler® device
Salmeteroldrug
Salmeterol 50 mcg twice daily via Diskus® device