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Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD
Sponsor: Chiesi Farmaceutici S.p.A.
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.
Official title: 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
Key Details
Gender
All
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1368
Start Date
2014-03-21
Completion Date
2016-01-14
Last Updated
2026-07-20
Healthy Volunteers
No
Interventions
Beclometasone/Formoterol/Glycopyrrolate
Active drug tested
Beclometasone/Formoterol
Active comparator
Locations (1)
Dr Beatrix BALINT
Szeged, Hungary