Overview

4-Week Study of Efficacy, Safety and PK of Albuterol-HFA Versus Proventil-HFA in Pediatric Asthma

Status:
Terminated
Trial end date:
2008-12-01
Target enrollment:
Participant gender:
Summary
This 4-week clinical study evaluates the efficacy and safety of Albuterol Sulfate HFA Inhalation Aerosol in comparison with the Active Control, Proventil-HFA (3M Pharmaceuticals, Inc) in pediatric patients (4-11 years old) with mild-to-moderate asthma. In addition, pharmacokinetic profile in this population will be evaluated using a population PK approach with sparse blood samples.
Phase:
Phase 3
Details
Lead Sponsor:
Amphastar Pharmaceuticals, Inc.
Treatments:
Albuterol