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COMPLETED
NCT01917331
PHASE3

Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate Versus Foster® in COPD

Sponsor: Chiesi Farmaceutici S.p.A.

View on ClinicalTrials.gov

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

DRUG

Beclometasone/Formoterol/Glycopyrrolate

Active drug tested

DRUG

Beclometasone/Formoterol

Active comparator

Locations (1)

Dr Beatrix BALINT

Szeged, Hungary