Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) Patients
NCT00972140 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 457
Last updated 2011-12-13
Summary
The purpose of this study is to demonstrate the clinical equivalence of formoterol-HFA pMDI 12µg/actuation administered twice daily to formoterol DPI 12µg/capsule delivered by the Aerolizer inhaler and administered twice daily in patients with COPD.
Conditions
Interventions
- DRUG
-
Formoterol
Formoterol-HFA pMDI 12µg twice daily
- DRUG
-
Formoterol
Formoterol-DPI 12 µg twice daily
Sponsors & Collaborators
-
Chiesi Farmaceutici S.p.A.
lead INDUSTRY
Principal Investigators
-
Iwona Graelewska Rzymowska, Prof · Clinic Pneumology and Allergology Lodz Poland
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2005-08-31
- Primary Completion
- 2006-04-30
- Completion
- 2006-10-31
Countries
- Poland
Study Locations
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