Status:
COMPLETED
Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)
Lead Sponsor:
Sumitomo Pharma America, Inc.
Conditions:
Reactive Airways Disease (RAD)
Eligibility:
All Genders
Up to 48 years
Phase:
PHASE3
Brief 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.
Detailed Description
A double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in pediatric subjects presenting with acute reactive airways disease. This study was previously posted ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2001
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2002
Estimated Enrollment :
117 Patients enrolled
Trial Details
Trial ID
NCT00685126
Start Date
February 1 2001
End Date
July 1 2002
Last Update
February 22 2012
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Little Rock, Arkansas, United States
2
Corona, California, United States
3
Englewood, California, United States
4
Huntington Beach, California, United States