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Efficacy of Fixed Combination of Beclometasone + Formoterol + Glycopyrrolate in Chronic Obstructive Pulmonary Disease

NCT01911364 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3686

Last updated 2021-10-29

No results posted yet for this study

Summary

The purpose of this study is to determine the triple combination of beclometasone dipropionate+Formoterol fumarate+Glycopyrrolate bromide is effective for the treatment of severe COPD patients (chronic obstructive pulmonary disease)

Conditions

Interventions

DRUG

BDP/FF/GB

Superiority over Tiotropium

DRUG

Tiotropium

Superiority of CHF5993 over Tiotropium

DRUG

BDP/FF + Tiotropium

non inferiority vs CHF5993

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Jorgen Vestbo, MD · Respiratory Research Group, Wythenshawe Hospital, MANCHESTER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-03-31
Completion
2016-03-31

Countries

  • Germany
  • Hungary
  • Italy

Study Locations

More Related Trials

Entities

Diseases

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 NCT01911364 on ClinicalTrials.gov