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

Chiesi commits to sharing with qualified scientific and medical Researchers, conducting legitimate research, Patient-level Data, Study-level Data, the Clinical Protocol and the full CSR, providing access to clinical trial information consistently with the principle of safeguarding commercially confidential information and patient privacy. Any shared Patient-level Data is anonymized to protect personally identifiable information.

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.

Chiesi access criteria and complete process for clinical data sharing is available on the Chiesi Group website.