Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
Trigon
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
2 other identifiers
interventional
100
4 countries
29
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2 chronic-obstructive-pulmonary-disease
Started Jun 2014
Shorter than P25 for phase_2 chronic-obstructive-pulmonary-disease
29 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2014
CompletedFirst Submitted
Initial submission to the registry
July 2, 2014
CompletedFirst Posted
Study publicly available on registry
July 14, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2015
CompletedOctober 29, 2021
October 1, 2021
8 months
July 2, 2014
October 28, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in pre-dose morning FEV1 on Day 28
Day 28
Secondary Outcomes (1)
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)
Day 28
Study Arms (2)
CHF 5259
EXPERIMENTALCHF 5259
Placebo
PLACEBO COMPARATORPlacebo
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (29)
Chiesi Clinical Trial Site 1017
Sevlievo, 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
Sofia, Bulgaria
Chiesi Clinical Trial Site 1012
Stara Zagora, Bulgaria
Chiesi Clinical Trial Site 1013
Troyan Municipality, Bulgaria
Chiesi Clinical Trial Site 2024
Berlin, Germany
Chiesi Clinical Trial Site 2028
Berlin, Germany
Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf
Großhansdorf, D-22927, Germany
Chiesi Clinical Trial Site 2027
Hamburg, Germany
Chiesi Clinical Trial Site 2026
Leipzig, Germany
Chiesi Clinical Trial Site 2023
Magdeburg, Germany
Chiesi Clinical Trial Site 2021
Radebeul, Germany
Chiesi Clinical Trial Site 2022
Witten, Germany
Chiesi Clinical Trial Site 3039
Bydgoszcz, Poland
Chiesi Clinical Trial Site 3032
Katowice, Poland
Chiesi Clinical Trial Site 3035
Krakow, Poland
Chiesi Clinical Trial Site 3037
Lubin, Poland
Chiesi Clinical Trial Site 3031
Ostrowiec Świętokrzyski, Poland
Chiesi Clinical Trial Site 3033
Oświęcim, Poland
Chiesi Clinical Trial Site 3038
Rzeszów, Poland
Chiesi Clinical Trial Site 3034
Tarnów, Poland
Chiesi Clinical Trial Site 3030
Wroclaw, Poland
Chiesi Clinical Trial Site 3036
Zgierz, Poland
Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus
London, SW7 2AZ, United Kingdom
Chiesi Clinical Trial Site 4042
London, United Kingdom
Chiesi Clinical Trial Site 4041
Manchester, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael POLKEY, MD
Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus, London SW7 2AZ; UK
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2014
First Posted
July 14, 2014
Study Start
June 1, 2014
Primary Completion
February 1, 2015
Study Completion
February 1, 2015
Last Updated
October 29, 2021
Record last verified: 2021-10
Data Sharing
- IPD Sharing
- Will share
- Access Criteria
- Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.
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.