Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.

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

Details

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

Criteria

Inclusion Criteria:

• COPD over 40 years of age (30 to 60% post-bronchodilator FEV1 predictive value)

• Patients under Double

• Patients under triple therapy (for 1 Mo prior Screening)

Exclusion Criteria:

• Pregnant or lactating women

• Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics, hospitalization

• concommitant diseases impacting feasibility or safety