Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate

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

A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess Efficacy and Safety of 3 Free Doses of Glycopyrrolate With Beclomethasone/Formoterol pMDI for the Treatment of COPD Patients

dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 4-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF GLYCOPYRROLATE WITH FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL (FOSTER®) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Study Type

Interventional

Enrollment (Actual)

281

Phase

  • Phase 2

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

  • United Kingdom
      • Manchester, United Kingdom
        • Medicines Evaluation Unit Ltd.

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 to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • COPD over 40 years of age (30 to 60% post-bronchodilator FEV1 predictive value)
  • Patients under Double
  • Patients under triple therapy (for 1 Mo prior Screening)

Exclusion Criteria:

  • Pregnant or lactating women
  • Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics, hospitalization
  • concommitant diseases impacting feasibility or safety

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: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Glyco 25
BDP/FF (400/24 daily)+ Glyco 25µg daily
Drug: Glycopyrrolate
comparison of different dosages of drug
Other Names:
  • Foster+GLyco 100
EXPERIMENTAL: Glyco 50
BDP/FF (400/24 daily)+ Glyco 50 µg daily
Drug: Glycopyrrolate
comparison of different dosages of drug
Other Names:
  • Foster+GLyco 100
EXPERIMENTAL: Glyco 100
BDP/FF (400/24 daily)+ Glyco 100µg daily
Drug: Glycopyrrolate
comparison of different dosages of drug
Other Names:
  • Foster+GLyco 100
ACTIVE_COMPARATOR: BDP/FF 400/24
Drug: Comparator
comparison of different dosages of drug versus comparator
Other Names:
  • Foster

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Aera under curve FEV1 AUC 0-12h
Time Frame: day 1 and 7 of treatment period
day 1 and 7 of treatment period

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, Clinical Pharmacology and Respiratory Medicine, Medicines Evaluation Unit Ltd, Manchester University

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, 2012

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

November 18, 2011

First Submitted That Met QC Criteria

November 18, 2011

First Posted (ESTIMATE)

November 22, 2011

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

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCD-1106-PR-0066

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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