A Dose Ranging Study of Arformoterol Given Once Daily Compared to Arformoterol Given Twice Daily in Subjects With Chronic Obstructive Pulmonary Disease (COPD)
NCT00691405 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 215
Last updated 2012-02-22
Summary
A dose ranging study to evaluate the safety, tolerability and efficacy of arformoterol (given once or twice a day) in subjects with COPD.
Conditions
Interventions
- DRUG
-
Arformoterol tartrate inhalation solution
Arformoterol 5 mcg BID
- DRUG
-
Arformoterol tartrate inhalation solution
Arformoterol 15 mcg BID
- DRUG
-
Arformoterol tartrate inhalation solution
Arformoterol 25 mcg BID
- DRUG
-
Placebo inhalation solution BID
- DRUG
-
Arformoterol tartrate inhalation solution
Arformoterol 15 mcg QD
- DRUG
-
Arformoterol tartrate inhalation solution
Arformoterol 25 mcg QD
- DRUG
-
Arformoterol tartrate inhalation solution
Arformoterol 50 mcg QD
- DRUG
-
Placebo inhalation solution QD
Sponsors & Collaborators
-
Sumitomo Pharma America, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2003-10-31
- Primary Completion
- 2004-05-31
- Completion
- 2004-05-31
Countries
- United States
Study Locations
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