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

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

A 52-wk Randomized Double Blind Parallel Trial: Combination of Beclometasone+Formoterol+Glycopyrrolate vs Tiotropium and vs Combination of Beclometasone+Formoterol and Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A 52-WEEK, DOUBLE BLIND, DOUBLE DUMMY, RANDOMIZED, 3-ARM PARALLEL GROUP, ACTIVE CONTROLLED CLINICAL TRIAL OF FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE PLUS GLYCOPYRROLATE BROMIDE ADMINISTERED VIA PMDI (CHF 5993) VERSUS TIOTROPIUM BROMIDE AND VERSUS FIXED COMBINATION OF BECLOMETASONE DIPROPIONATE PLUS FORMOTEROL FUMARATE ADMINISTERED VIA PMDI AND TIOTROPIUM BROMIDE IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE

A total of 8 clinic visits (V0 to V7) will be performed during the study, as follows:

  • A pre-screening visit (V0) to obtain the written informed consent from the patient
  • A screening visit (V1) to establish the eligibility of patients, followed by a 2-week open-label run-in under Tiotropium
  • After the randomisation (V2), patients will be assessed after 4, 12, 26, 40 and 52 weeks of treatment (V3 to V7) The assessments performed at visits include routine haematology and blood chemistry, medical history, physical examination, a 12-lead ECG, spirometric parameters, vital signs).

During the run-in and the randomised treatment periods, patients use an e-diary to record symptoms, rescue medication use and compliance to the study medications daily.

AEs/SAEs and COPD exacerbations will be monitored.

Study Type

Interventional

Enrollment (Actual)

3686

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

  • Germany
      • Hessen, Germany
        • Institut für klinische Forschung
  • Hungary
      • Szeged, Hungary
        • Csongrad Megyei Mellkasi Betegsegek Szakkorhaza
  • Italy
      • Perugia, Italy
        • Azienda Ospedaliera Perugia

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 and female COPD patients aged ≥ 40 years
  • Current smokers or ex-smokers
  • FEV1<50% predicted (FEV1/FVC <0,7)
  • at least 1 documented exacerbations in the last 12 Mo

Exclusion Criteria:

  • Pregnant or lactating women and all women physiologically capable of becoming pregnant
  • Diagnosis of asthma, history of allergic rhinitis or atopy
  • Patients treated for exacerbations 1 Mo prior to screening
  • Patients treated with non-cardioselective β-blockers
  • Patients treated with long-acting antihistamines
  • 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
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: BDP/FF/GB
CHF 5993 pMDI 100/6/12.5 mcg 2 inhalations b.i.d
Drug: BDP/FF/GB
Superiority over Tiotropium
Other Names:
  • CHF 5993 pMDI 100/6/12.5 mcg
ACTIVE_COMPARATOR: Tiotropium
Tiotropium bromide 18 mcg
Drug: Tiotropium
Superiority of CHF5993 over Tiotropium
Other Names:
  • Spiriva 18 mcg 1 capsule o.d
ACTIVE_COMPARATOR: BDP/FF + Tiotropium

BDP/FF pMDI 100/6/12.5 mcg 2 inhalations b.i.d and Tiotropium 18 mcg daily

BDP/FF/GB versus BDP/FF + Tiotropium
Drug: BDP/FF + Tiotropium
non inferiority vs CHF5993
Other Names:
  • Foster 100/6 mcg 2 inhalations bid + Spiriva 18 mcg o.d.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pre-dose morning FEV1
Time Frame: 52 weeks
Change from baseline in pre-dose morning FEV1 at Week 52.
52 weeks

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: Jorgen Vestbo, MD, Respiratory Research Group, Wythenshawe Hospital, MANCHESTER

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

January 1, 2014

Primary Completion (ACTUAL)

March 1, 2016

Study Completion (ACTUAL)

March 1, 2016

Study Registration Dates

First Submitted

July 26, 2013

First Submitted That Met QC Criteria

July 26, 2013

First Posted (ESTIMATE)

July 30, 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-1208-PR-0090
  • 2013-000063-91 (EUDRACT_NUMBER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

IPD Sharing Access Criteria

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

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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