Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
NCT00073840 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 386
Last updated 2012-02-22
Summary
The primary objective of this study is to investigate the efficacy of levalbuterol 90 ug (2 actuations, 45 ug each) versus placebo (2 actuations) in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).
Conditions
Interventions
- DRUG
-
levalbuterol
* Levalbuterol 90 ųg QID (manufacturing sites A or B); * Racemic Albuterol 180 ųg QID; * Placebo QID
Sponsors & Collaborators
-
Sumitomo Pharma America, Inc.
lead INDUSTRY
Principal Investigators
-
John Hanrahan, M.D. · Sumitomo Pharma America, Inc.
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 12 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2002-12-31
- Primary Completion
- 2003-06-30
- Completion
- 2003-06-30
Countries
- United States
Study Locations
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