Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients (Trigon)

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

A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease

The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

A Multinational, Multicentre, Randomised, Double Blind, Placebo-Controlled, 2-way Crossover Study to Evaluate the Efficacy and Safety of Glycopyrrolate Bromide Administered Via pMDI (CHF 5259), for the Treatment of Patients With Chronic Obstructive Pulmonary Disease

Study Type

Interventional

Enrollment (Actual)

100

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

  • Bulgaria
      • Sevlievo, Bulgaria
        • Chiesi Clinical Trial Site 1017
      • Sofia, Bulgaria
        • Chiesi Clinical Trial Site 1010
      • Sofia, Bulgaria
        • Chiesi Clinical Trial Site 1011
      • Sofia, Bulgaria
        • Chiesi Clinical Trial Site 1014
      • Sofia, Bulgaria
        • Chiesi Clinical Trial Site 1015
      • Sofia, Bulgaria
        • Chiesi Clinical Trial Site 1016
      • Stara Zagora, Bulgaria
        • Chiesi Clinical Trial Site 1012
      • Troyan, Bulgaria
        • Chiesi Clinical Trial Site 1013
  • Germany
      • Berlin, Germany
        • Chiesi Clinical Trial Site 2024
      • Berlin, Germany
        • Chiesi Clinical Trial Site 2028
      • Großhansdorf, Germany, D-22927
        • Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf
      • Hamburg, Germany
        • Chiesi Clinical Trial Site 2027
      • Leipzig, Germany
        • Chiesi Clinical Trial Site 2026
      • Magdeburg, Germany
        • Chiesi Clinical Trial Site 2023
      • Radebeul, Germany
        • Chiesi Clinical Trial Site 2021
      • Witten, Germany
        • Chiesi Clinical Trial Site 2022
  • Poland
      • Bydgoszcz, Poland
        • Chiesi Clinical Trial Site 3039
      • Katowice, Poland
        • Chiesi Clinical Trial Site 3032
      • Kraków, Poland
        • Chiesi Clinical Trial Site 3035
      • Lubin, Poland
        • Chiesi Clinical Trial Site 3037
      • Ostrowiec Świętokrzyski, Poland
        • Chiesi Clinical Trial Site 3031
      • Oświęcim, Poland
        • Chiesi Clinical Trial Site 3033
      • Rzeszów, Poland
        • Chiesi Clinical Trial Site 3038
      • Tarnów, Poland
        • Chiesi Clinical Trial Site 3034
      • Wrocław, Poland
        • Chiesi Clinical Trial Site 3030
      • Zgierz, Poland
        • Chiesi Clinical Trial Site 3036
  • United Kingdom
      • London, United Kingdom, SW7 2AZ
        • Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus
      • London, United Kingdom
        • Chiesi Clinical Trial Site 4042
      • Manchester, United Kingdom
        • Chiesi Clinical Trial Site 4041

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:

  • Male and female adults (40 ≤ age ≤ 80 years) with a diagnosis of COPD
  • Current smokers or ex-smokers
  • A post-bronchodilator FEV1 < 60% of the predicted normal value and a post-bronchodilator FEV1/FVC < 0.7
  • Positive response to the reversibility test at screening defined as change in FEV1 ≥ 5%.
  • BDI score ≤ 10
  • Patients free of exacerbations for at least 1 month

Exclusion Criteria:

  • Pregnant or lactating women
  • Diagnosis of asthma
  • 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: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Placebo
Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
Experimental: CHF 5259
Drug: CHF 5259
Comparison of CHF 5259 versus placebo over a treatment period. Allocation of 1 of the 2 possible treatments performed in sequence during a cross over design.
Other Names:
  • glycopyrrolate bromide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in pre-dose morning FEV1 on Day 28
Time Frame: Day 28
Day 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to day 28 in area under the curve for forced expiratory volume in 1 second measured at 11 timepoints between 0 to 12 hours postdose (FEV1 AUC0-12h)
Time Frame: Day 28
Day 28

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: Michael POLKEY, MD, Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus, London SW7 2AZ; 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.

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

June 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

February 1, 2015

Study Registration Dates

First Submitted

July 2, 2014

First Submitted That Met QC Criteria

July 10, 2014

First Posted (Estimate)

July 14, 2014

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-05993AA1-09
  • 2013-005268-25 (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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