Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients

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

The purpose of this study is to evaluate the efficacy and safety of CHF 5259 (glycopyrrolate bromide) for the treatment of COPD patients.

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

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