Status:
COMPLETED
Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
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 th...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2015
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT02189577
Start Date
June 1 2014
End Date
February 1 2015
Last Update
October 29 2021
Active Locations (29)
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1
Chiesi Clinical Trial Site 1017
Sevlievo, Bulgaria
2
Chiesi Clinical Trial Site 1010
Sofia, Bulgaria
3
Chiesi Clinical Trial Site 1011
Sofia, Bulgaria
4
Chiesi Clinical Trial Site 1014
Sofia, Bulgaria