At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 3 Randomised Double Blind Randomised Parallel Multinational Trial Comparing a Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate to Foster® in Patients With Chronic Obstructive Pulmonary Disease
In Brief
A Phase 3 clinical trial evaluating Beclometasone/Formoterol/Glycopyrrolate and Beclometasone/Formoterol for Chronic Obstructive Pulmonary Disease (COPD). Completed, enrolled 1,368 participants across 1 site.
Signals
Detailed Summary
Randomized,double-blind,multicenter,multinational,parallel-group,Phase III study to demonstrate the superiority of the triple fixed combination of beclometasone + formoterol + glycopyrrolate (BDP/FF/GB) administered via pressurised metered dose inhaler (pMDI) over the equivalent dose of Foster® (beclometasone dipropionate (BDP) / formoterol fumarate (FF), in patients diagnosed with chronic obstructive pulmonary disease (COPD) after 52 weeks of treatment.
Study Details
Timeline
Arms & Interventions
CHF 5993 pMDI 100/6/12.5 µg 2 inhalations bid
Foster® 100/6 µg 2 inhalations bid
Interventions
Active drug tested
Active comparator