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

October 28, 2021 updated by: Chiesi Farmaceutici S.p.A.

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

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 pMDI over the equivalent dose of Foster® in COPD (Chronic Obstructive Pulmonary Disease) patients after 52 weeks of treatment

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This 52-week randomised 2 parallel groups study aimed at evaluating the superiority of fixed triple therapy with ICS/LABA/LAMA compared to ICS/LABA in severe to very severe COPD patients.

Patients' eligibility was checked during the screening visit including the review of medical history, spirometry assessments, routine labs, physical examination, 12-lead ECG, vital signs measurement. This visit was followed by a 2-week open-label run-in period under Foster® (BDP/FF 400/24 µg total daily dose). Eligible patients were then randomised to either fixed triple therapy BDP/FF/GB or BDP/FF. During the 52-week treatment period, completing patients did have 5 subsequent visits post randomisation scheduled respectively after 4 (Visit 3), 12 (Visit 4), 26 (Visit 5), 40 (Visit 6) and 52 (Visit 7) weeks of treatment.

During these, pre-dose and post-dose spirometry, 12-lead ECG, vital signs, dyspnea assessments were performed. Rescue medication use, compliance with the treatment and EXACT-PRO questionnaire were recorded daily (via an electronic diary) during the run-in and randomised treatment periods.

Study Type

Interventional

Enrollment (Actual)

1368

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hungary
      • Szeged, Hungary, 6722
        • Dr Beatrix BALINT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male or female adults aged ≥ 40 years with a diagnosis of COPD
  • Current smokers or ex-smokers
  • A post-bronchodilator FEV1 < 50% of the predicted normal value and a post- bronchodilator FEV1/FVC < 0.7
  • At least one exacerbation in the 12 months preceding the screening visit

Exclusion Criteria:

  • Pregnant or lactating women
  • Diagnosis of asthma or history of allergic rhinitis or atopy
  • Patients treated with non-cardioselective β-blockers in the month preceding the screening visit
  • Patients treated for exacerbations in the 4 weeks prior to screening visit
  • Patients treated with long-acting antihistamines unless taken at stable regimen at least 2 months prior to screening and to be maintained constant during the study or if taken as PRN
  • Patients requiring long term (at least 12 hours daily) oxygen therapy for chronic hypoxemia
  • Known respiratory disorders other than COPD
  • Patients who have clinically significant cardiovascular condition

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Beclometasone/Formoterol/Glycopyrrolate
CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations bid
Drug: Beclometasone/Formoterol/Glycopyrrolate
Active drug tested
Other Names:
  • BDP/FF/GB or CHF 5993 pMDI 100/6/12.5 mcg
Active Comparator: Beclometasone/Formoterol
Foster® 100/6 mcg 2 inhalations bid
Drug: Beclometasone/Formoterol
Active comparator
Other Names:
  • Foster® or CHF 1535 pMDI 100/6 mcg

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre-dose and 2-hour post-dose morning FEV1 at week 26 and TDI score at week 26
Time Frame: week 26
  • Change from baseline in pre-dose morning FEV1 at Week 26.
  • Change from baseline to the 2-hour post-dose value of FEV1 at Week 26.
  • TDI focal score at Week 26
week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
COPD exacerbation rate
Time Frame: week 52
Moderate and severe COPD exacerbation rate over 52 weeks of treatment
week 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chiesi Farmaceutici S.p.A.

Investigators

  • Principal Investigator: Dave Singh, MD, University Hospital of South Manchester, MANCHESTER M23 9 QZ, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

August 5, 2013

First Submitted That Met QC Criteria

August 5, 2013

First Posted (Estimate)

August 6, 2013

Study Record Updates

Last Update Posted (Actual)

October 29, 2021

Last Update Submitted That Met QC Criteria

October 28, 2021

Last Verified

October 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-1207-PR-0091

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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