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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CHF 5259
Placebo
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary disease, COPD

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Chiesi Clinical Trial Site 1017
  • Chiesi Clinical Trial Site 1010
  • Chiesi Clinical Trial Site 1011
  • Chiesi Clinical Trial Site 1014
  • Chiesi Clinical Trial Site 1015
  • Chiesi Clinical Trial Site 1016
  • Chiesi Clinical Trial Site 1012
  • Chiesi Clinical Trial Site 1013
  • Chiesi Clinical Trial Site 2024
  • Chiesi Clinical Trial Site 2028
  • Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf
  • Chiesi Clinical Trial Site 2027
  • Chiesi Clinical Trial Site 2026
  • Chiesi Clinical Trial Site 2023
  • Chiesi Clinical Trial Site 2021
  • Chiesi Clinical Trial Site 2022
  • Chiesi Clinical Trial Site 3039
  • Chiesi Clinical Trial Site 3032
  • Chiesi Clinical Trial Site 3035
  • Chiesi Clinical Trial Site 3037
  • Chiesi Clinical Trial Site 3031
  • Chiesi Clinical Trial Site 3033
  • Chiesi Clinical Trial Site 3038
  • Chiesi Clinical Trial Site 3034
  • Chiesi Clinical Trial Site 3030
  • Chiesi Clinical Trial Site 3036
  • Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus
  • Chiesi Clinical Trial Site 4042
  • Chiesi Clinical Trial Site 4041

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CHF 5259

Placebo

Arm Description

CHF 5259

Placebo

Outcomes

Primary Outcome Measures

Change from baseline in pre-dose morning FEV1 on Day 28

Secondary Outcome Measures

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)

Full Information

First Posted
July 2, 2014
Last Updated
October 28, 2021
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT02189577
Brief Title
Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
Acronym
Trigon
Official Title
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

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
June 2014 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary disease, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CHF 5259
Arm Type
Experimental
Arm Description
CHF 5259
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
CHF 5259
Other Intervention Name(s)
glycopyrrolate bromide
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change from baseline in pre-dose morning FEV1 on Day 28
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael POLKEY, MD
Organizational Affiliation
Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus, London SW7 2AZ; UK
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chiesi Clinical Trial Site 1017
City
Sevlievo
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 1010
City
Sofia
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 1011
City
Sofia
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 1014
City
Sofia
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 1015
City
Sofia
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 1016
City
Sofia
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 1012
City
Stara Zagora
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 1013
City
Troyan
Country
Bulgaria
Facility Name
Chiesi Clinical Trial Site 2024
City
Berlin
Country
Germany
Facility Name
Chiesi Clinical Trial Site 2028
City
Berlin
Country
Germany
Facility Name
Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf
City
Großhansdorf
ZIP/Postal Code
D-22927
Country
Germany
Facility Name
Chiesi Clinical Trial Site 2027
City
Hamburg
Country
Germany
Facility Name
Chiesi Clinical Trial Site 2026
City
Leipzig
Country
Germany
Facility Name
Chiesi Clinical Trial Site 2023
City
Magdeburg
Country
Germany
Facility Name
Chiesi Clinical Trial Site 2021
City
Radebeul
Country
Germany
Facility Name
Chiesi Clinical Trial Site 2022
City
Witten
Country
Germany
Facility Name
Chiesi Clinical Trial Site 3039
City
Bydgoszcz
Country
Poland
Facility Name
Chiesi Clinical Trial Site 3032
City
Katowice
Country
Poland
Facility Name
Chiesi Clinical Trial Site 3035
City
Kraków
Country
Poland
Facility Name
Chiesi Clinical Trial Site 3037
City
Lubin
Country
Poland
Facility Name
Chiesi Clinical Trial Site 3031
City
Ostrowiec Świętokrzyski
Country
Poland
Facility Name
Chiesi Clinical Trial Site 3033
City
Oświęcim
Country
Poland
Facility Name
Chiesi Clinical Trial Site 3038
City
Rzeszów
Country
Poland
Facility Name
Chiesi Clinical Trial Site 3034
City
Tarnów
Country
Poland
Facility Name
Chiesi Clinical Trial Site 3030
City
Wrocław
Country
Poland
Facility Name
Chiesi Clinical Trial Site 3036
City
Zgierz
Country
Poland
Facility Name
Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus
City
London
ZIP/Postal Code
SW7 2AZ
Country
United Kingdom
Facility Name
Chiesi Clinical Trial Site 4042
City
London
Country
United Kingdom
Facility Name
Chiesi Clinical Trial Site 4041
City
Manchester
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing URL
https://www.chiesi.com/en/chiesi-clinical-trial-data-request-portal/
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=2013-005268-25
Description
Study Record on EU Clinical Trials Register including results
URL
https://www.chiesi.com/clinic/CSR_Synopsis_CCD-05993AA1-09.pdf
Description
CSR Synopsis available in the CHIESI Clinical Study Register

Learn more about this trial

Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients

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