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

NCT01917331 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1368

Last updated 2026-07-20

Study results available
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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.

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Interventions

DRUG

Beclometasone/Formoterol/Glycopyrrolate

Active drug tested

DRUG

Beclometasone/Formoterol

Active comparator

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Dave SINGH, MD · University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-21
Primary Completion
2016-01-14
Completion
2016-01-14

Countries

  • Hungary

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01917331 on ClinicalTrials.gov