Efficacy and Safety of Levalbuterol Versus Racemic Albuterol in Asthma
NCT00667407 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 627
Last updated 2012-02-22
Summary
To investigate the Efficacy and Safety of Levalbuterol versus Racemic Albuterol in the Treatment of Acute Asthma.
Conditions
Interventions
- DRUG
-
Levalbuterol 1.25 mg
levalbuterol 1.25 mg Period I: administered every 20 minutes for the first 3 doses, and then every 40 minutes for the next 3 doses; then as clinically indicated. Period II: TID for 3 days (same time of day), then PRN to TID for 7 days
- DRUG
-
Racemic Albuterol Sulfate
Racemic Albuterol 2.5 mg Period I: every 20 min for the first 3 doses, then every 40 min for the next 3 doses, then as clinically indicated. Period II: TID for 3 days then PRN to TID for 7 days
Sponsors & Collaborators
-
Sumitomo Pharma America, Inc.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2000-11-30
- Primary Completion
- 2002-08-31
- Completion
- 2002-08-31
Countries
- United States
Study Locations
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