Flutiform® Compared With Seretide® in the Treatment of COPD
Phase 2
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT02195375
- Lead Sponsor
- Mundipharma Research Limited
- Brief Summary
The purpose of this study is to investigate whether flutiform® is effective and safe in the treatment of chronic obstructive pulmonary disease (COPD).
- Detailed Description
A multi-centre, randomised, double-blind, double dummy, active-controlled, parallel-group study in male and female subjects conducted to assess the efficacy and safety of flutiform in the treatment of COPD. Subjects will be randomised to one of three treatment groups in a 1:1:1 ratio. Throughout the study subjects will be assessed on a mixture of symptom based and lung function measurements to monitor their progress in the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 923
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Flutiform 250/10 µg BID Flutiform 250/10 µg BID Flutiform 125/5 (2 puffs BID) Seretide Accuhaler 50/500 µg BID Seretide Accuhaler 50/500 µg BID Seretide Accuhaler 50/500 (BID) Flutiform 500/20 µg BID Flutiform 500/20 µg BID Flutiform 250/10 (2 puffs BID)
- Primary Outcome Measures
Name Time Method Average pre-dose FEV1 26 weeks
- Secondary Outcome Measures
Name Time Method Average 1 hour Post dose FEV1, FVC, FEV6 26 Weeks