Chronic Obstructive Pulmonary Disease Clinical Trial
— TrigonOfficial 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
Verified date | October 2021 |
Source | Chiesi Farmaceutici S.p.A. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.
Status | Completed |
Enrollment | 100 |
Est. completion date | February 2015 |
Est. primary completion date | February 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
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 | |
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 | 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 | |
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 Swietokrzyski | |
Poland | Chiesi Clinical Trial Site 3033 | Oswiecim | |
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 | |
United Kingdom | Chiesi Clinical Trial Site 4042 | London | |
United Kingdom | Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus | London | |
United Kingdom | Chiesi Clinical Trial Site 4041 | Manchester |
Lead Sponsor | Collaborator |
---|---|
Chiesi Farmaceutici S.p.A. |
Bulgaria, Germany, Poland, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline in pre-dose morning FEV1 on Day 28 | Day 28 | ||
Secondary | 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 |
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