Chronic Obstructive Pulmonary Disease
Conditions
Keywords
Chronic Obstructive Pulmonary disease, COPD
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
Interventions
DRUGCHF 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.
DRUGPlacebo
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.
Sponsors
Chiesi Farmaceutici S.p.A.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in pre-dose morning FEV1 on Day 28 | Day 28 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Bulgaria, Germany, Poland, United Kingdom
Outcome results
None listed