Randomized Cross Over Study to Assess Efficacy and Safety of BDP/FF and Glycopyrrolate
Phase 2
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Drug: Comparator
- Registration Number
- NCT01476813
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- 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 BECLOMETHASONE DIPROPIONATE PLUS FORMOTEROL (FOSTER®) IN A METERED DOSE INHALER FOR THE TREATMENT OF PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 281
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Glyco 25 Glycopyrrolate BDP/FF (400/24 daily)+ Glyco 25µg daily Glyco 50 Glycopyrrolate BDP/FF (400/24 daily)+ Glyco 50 µg daily Glyco 100 Glycopyrrolate BDP/FF (400/24 daily)+ Glyco 100µg daily BDP/FF 400/24 Comparator BDP/FF 400/24
- Primary Outcome Measures
Name Time Method Aera under curve FEV1 AUC 0-12h day 1 and 7 of treatment period
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Medicines Evaluation Unit Ltd.
🇬🇧Manchester, United Kingdom