Study in Subjects Greater Than 40 Years of Age With COPD
NCT00507234 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 128
Last updated 2010-11-11
Summary
This is a multicenter, Phase IIIb, randomized, double-blind, active-controlled, parallel-group, comparative study.
The objectives of this study are:
1. To compare the efficacy of tiotropium 18 mcg once daily plus Formoterol Fumarate Inhalation Solution (FFIS) 20 mcg twice daily to tiotropium 18 mcg once daily.
2. To obtain safety data on the use of tiotropium 18 mcg once daily plus FFIS 20 mcg twice daily compared to tiotropium 18 mcg once daily.
Conditions
Interventions
- DRUG
-
formoterol fumarate inhalation solution
Sponsors & Collaborators
-
Dey
lead INDUSTRY
Principal Investigators
-
Nicola A Hanania, MD · Baylor College of Medicine
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-03-31
- Primary Completion
- 2007-10-31
- Completion
- 2008-04-30
Countries
- United States
Study Locations
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