Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Drug: Placebo
- Registration Number
- NCT02189577
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 100
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description CHF 5259 CHF 5259 CHF 5259 Placebo Placebo Placebo
- Primary Outcome Measures
Name Time Method Change from baseline in pre-dose morning FEV1 on Day 28 Day 28
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (29)
Site 2020 - Pulmonary Research Institute at Hospital Grosshansdorf
🇩🇪Großhansdorf, Germany
Chiesi Clinical Trial Site 1015
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 1013
🇧🇬Troyan, Bulgaria
Chiesi Clinical Trial Site 2024
🇩🇪Berlin, Germany
Chiesi Clinical Trial Site 1014
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 2023
🇩🇪Magdeburg, Germany
Chiesi Clinical Trial Site 1017
🇧🇬Sevlievo, Bulgaria
Chiesi Clinical Trial Site 1012
🇧🇬Stara Zagora, Bulgaria
Chiesi Clinical Trial Site 1016
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 3037
🇵🇱Lubin, Poland
Chiesi Clinical Trial Site 2026
🇩🇪Leipzig, Germany
Chiesi Clinical Trial Site 1010
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 3039
🇵🇱Bydgoszcz, Poland
Chiesi Clinical Trial Site 3033
🇵🇱Oświęcim, Poland
Chiesi Clinical Trial Site 3030
🇵🇱Wrocław, Poland
Chiesi Clinical Trial Site 3038
🇵🇱Rzeszów, Poland
Site 4040 - Royal Brompton and Harefield NHS Foundation Trust; South Kensington Campus
🇬🇧London, United Kingdom
Chiesi Clinical Trial Site 1011
🇧🇬Sofia, Bulgaria
Chiesi Clinical Trial Site 2027
🇩🇪Hamburg, Germany
Chiesi Clinical Trial Site 2028
🇩🇪Berlin, Germany
Chiesi Clinical Trial Site 3035
🇵🇱Kraków, Poland
Chiesi Clinical Trial Site 3031
🇵🇱Ostrowiec Świętokrzyski, Poland
Chiesi Clinical Trial Site 2022
🇩🇪Witten, Germany
Chiesi Clinical Trial Site 2021
🇩🇪Radebeul, Germany
Chiesi Clinical Trial Site 3032
🇵🇱Katowice, Poland
Chiesi Clinical Trial Site 3034
🇵🇱Tarnów, Poland
Chiesi Clinical Trial Site 4042
🇬🇧London, United Kingdom
Chiesi Clinical Trial Site 3036
🇵🇱Zgierz, Poland
Chiesi Clinical Trial Site 4041
🇬🇧Manchester, United Kingdom