BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)
Phase 3
Completed
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Interventions
- Registration Number
- NCT00929851
- Lead Sponsor
- Chiesi Farmaceutici S.p.A.
- Brief Summary
a 48-week, 2-arm parallel group, "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease
- Detailed Description
a 48-week, double blind, randomized, multinational, multicentre, 2-arm parallel group, reference treatment controlled clinical trial of "fixed combination" beclomethasone dipropionate plus formoterol fumarate versus formoterol in patients with severe chronic obstructive pulmonary disease
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1199
Inclusion Criteria
- Severe COPD
- At least one COPd exacerbation in previous year
Exclusion Criteria
- Asthma, allergic rhinitis or other atopic disease
- Unstable concurrent disease:
- Evidence of heart failure
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BDP/FF CHF1535 Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose inhaler Formoterol fumarate Formoterol fumarate Formoterol fumarate 12 µg per metered dose
- Primary Outcome Measures
Name Time Method Exacerbation rate Change in pre-dose FEV1 0-4-12-24-36-48 weeks
- Secondary Outcome Measures
Name Time Method Pulmonary function parameters(FEV1 - FVC) St George's Questionnaire Use of rescue medication 0-4-12-24-36-48 weeks
Trial Locations
- Locations (1)
UCL Medical School
🇬🇧London, United Kingdom