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

A Randomized, Double-blind, Active-controlled, Cross-over Study to Assess Efficacy and Safety of 3 Free Doses of Glycopyrrolate With Beclomethasone/Formoterol pMDI for the Treatment of COPD Patients

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

A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, ACTIVE-CONTROLLED, 4-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF A FREE COMBINATION OF 3 DOSES OF GLYCOPYRROLATE WITH FIXED COMBINATION BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL (FOSTER®) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

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