BDP/FF Versus Formoterol Fumarate (FF) in Patients With Severe COPD (Lung Function and Exacerbation Rate)
NCT00929851 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1199
Last updated 2021-10-29
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
Conditions
- Pulmonary Disease, Chronic Obstructive
Interventions
- DRUG
-
CHF1535
Beclomethasone dipropionate 100 µg plus formoterol fumarate 6 µg/per metered dose
- DRUG
-
Formoterol fumarate
Formoterol fumarate 12 µg per metered dose
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
lead INDUSTRY
Principal Investigators
-
Jadwiga A Wedzicha, MD, Prof · UCL MEDICAL SCHOOL
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-10-31
- Primary Completion
- 2012-03-31
- Completion
- 2012-07-31
Countries
- United Kingdom
Study Locations
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