Status:
COMPLETED
Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
Lead Sponsor:
Chiesi Farmaceutici S.p.A.
Conditions:
Pulmonary Disease, Chronic Obstructive
Eligibility:
All Genders
40-80 years
Phase:
PHASE2
Brief Summary
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.
Detailed Description
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 BECLOME...
Eligibility Criteria
Inclusion
- 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
- Pregnant or lactating women
- Patients experiencing a COPD exacerbation requiring use of systemic steroids and/or antibiotics, hospitalization
- concommitant diseases impacting feasibility or safety
Key Trial Info
Start Date :
March 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT01476813
Start Date
March 1 2012
End Date
July 1 2013
Last Update
October 29 2021
Active Locations (1)
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1
Medicines Evaluation Unit Ltd.
Manchester, United Kingdom