Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
Study Identifier:
CCD-1106-PR-0066
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Study Contact Information:
N/A
Study Complete
Trial Documents
Clinical Study Report
Available Languages: English
Study Details
Medical Condition
- Chronic Obstructive Pulmonary Disease
Study Drug
- Drug: Glycopyrrolate
- Drug: Comparator
Date
Mar 2012 - Sep 2012
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 40 - 80 Years
Requirements Information
Inclusion and Exclusion 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
Healthy Volunteers
No
Protocol Summary
dose-finding study to assess the optimal dose of glycopyrrolate daily dose on top of BDP/FF in COPD patients.
Study Locations
Location
Status
Location
Medicines Evaluation Unit Ltd.
Manchester, United Kingdom
Status
N/A