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

Completed · Phase 3

Conditions studied: Reactive Airways Disease (RAD)

In brief

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.

Key facts

Study ID

NCT00685126

Run by

Sumitomo Pharma America, Inc.

People needed

117

Starts

2001-02-01

Expected to finish

2002-07-01

Last updated by the study team

2012-02-22

Who can join

Age: any, up to 4. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study site — Little Rock, Arkansas, United States
• Study site — Corona, California, United States
• Study site — Englewood, California, United States
• Study site — Huntington Beach, California, United States
• Study site — Long Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — Denver, Colorado, United States
• Study site — Washington D.C., District of Columbia, United States
• Study site — Lake Worth, Florida, United States
• Study site — Tampa, Florida, United States
• Study site — Bloomington, Illinois, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lexington, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Marrero, Louisiana, United States
• Study site — Shreveport, Louisiana, United States
• Study site — Omaha, Nebraska, United States
• Study site — New York, New York, United States
• Study site — Raleigh, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Columbus, Ohio, United States
• Study site — Oswego, Ohio, United States

Full record on ClinicalTrials.gov

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