Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)

• Status: Completed
• Trial end date: 2002-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to compare the efficacy of two dose levels of levalbuterol compared with one dose level of racemic albuterol in pediatric subjects aged birth to 48 months old.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Albuterol; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Subject, male or female, must be between the ages of birth to 48 months inclusive at the time of consent.

• Subject must have experienced at least one previous episode or have a history of reactive airways disease.

• Subject must have an Oxygen saturation ≥ 90% at room air or with no more than 2 L/min supplemental Oxygen.

Exclusion Criteria:

• Subject who has participated in an investigational drug study within 30 days prior to study start, or who has previously participated in this study.

• Subject with a known sensitivity to levalbuterol or racemic albuterol, including Ventolin® or any of the excipients contained in any of these formulations.

• Subject using any prescription drug with which levalbuterol or racemic albuterol sulfate administration is contraindicated.