Efficacy and Safety of Glycopyrrolate Bromide of COPD Patients

• Status: Completed
• Trial end date: 2015-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Chiesi Farmaceutici S.p.A.
• Treatments: Bromides; Glycopyrrolate

Criteria

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