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Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients (Trigon)
This study has been completed.
Sponsor:
Chiesi Farmaceutici S.p.A.
Information provided by (Responsible Party):
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT02189577
First received: July 2, 2014
Last updated: March 28, 2017
Last verified: March 2017
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Purpose
The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.
| Condition | Intervention | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease | Drug: CHF 5259 Drug: Placebo | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Participant, Care Provider, Investigator, Outcomes Assessor Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Chiesi Farmaceutici S.p.A.:
Primary Outcome Measures:
- Change from baseline in pre-dose morning FEV1 on Day 28 [ Time Frame: 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) [ Time Frame: Day 28 ]
| Enrollment: | 100 |
| Study Start Date: | June 2014 |
| Study Completion Date: | February 2015 |
| Primary Completion Date: | February 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: CHF 5259
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 Name: glycopyrrolate bromide
|
|
Placebo Comparator: Placebo
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.
|
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
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT02189577
Please refer to this study by its ClinicalTrials.gov identifier: NCT02189577
Locations
| Bulgaria | |
| 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, Bulgaria | |
| Germany | |
| Chiesi Clinical Trial Site 2024 | |
| Berlin, Germany | |
| Chiesi Clinical Trial Site 2028 | |
| Berlin, Germany | |
| Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf | |
| Großhansdorf, Germany, D-22927 | |
| 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 | |
| Poland | |
| Chiesi Clinical Trial Site 3039 | |
| Bydgoszcz, Poland | |
| Chiesi Clinical Trial Site 3032 | |
| Katowice, Poland | |
| Chiesi Clinical Trial Site 3035 | |
| Kraków, 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 | |
| Wrocław, Poland | |
| Chiesi Clinical Trial Site 3036 | |
| Zgierz, Poland | |
| United Kingdom | |
| Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus | |
| London, United Kingdom, SW7 2AZ | |
| Chiesi Clinical Trial Site 4042 | |
| London, United Kingdom | |
| Chiesi Clinical Trial Site 4041 | |
| Manchester, United Kingdom | |
Sponsors and Collaborators
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 |
More Information
Additional Information:
| Responsible Party: | Chiesi Farmaceutici S.p.A. |
| ClinicalTrials.gov Identifier: | NCT02189577 History of Changes |
| Other Study ID Numbers: |
CCD-05993AA1-09 2013-005268-25 ( EudraCT Number ) |
| Study First Received: | July 2, 2014 |
| Last Updated: | March 28, 2017 |
Keywords provided by Chiesi Farmaceutici S.p.A.:
|
Chronic Obstructive Pulmonary disease COPD |
Additional relevant MeSH terms:
|
Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Bromides Glycopyrrolate Anticonvulsants |
Adjuvants, Anesthesia Muscarinic Antagonists Cholinergic Antagonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on July 17, 2017