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

Condition(s) targeted: Reactive Airways Disease (RAD)

Intervention: Levalbuterol HCl Inhalation Solution (Drug); Levalbuterol HCl Inhalation Solution (Drug); Albuterol HCl Inhalation Solution (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sepracor, Inc.

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.

Official title: A Safety, Tolerability and Efficacy Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects Birth to 48 Months Old With Reactive Airways Disease in an Acute Setting

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study

Primary outcome: Maximum decrease in Respiratory Status Scale© total score

Secondary outcome:

Time to meet discharge criteria or clinical decision to discharge.

Time to maximum decrease in Respiratory Status Scale© total score.

Individual Respiratory Status Scale© items.

Time to hospitalization.

Rate of hospitalization.

Detailed description: A double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in pediatric subjects presenting with acute reactive airways disease.

Minimum age: N/A. Maximum age: 48 Months. Gender(s): Both.

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.

Little Rock, Arkansas, United States

San Diego, California, United States

Sacramento, California, United States

Corona, California, United States

Long Beach, California, United States

Englewood, California, United States

Huntington Beach, California, United States

Denver, Colorado, United States

Washington, District of Columbia, United States

Lake Worth, Florida, United States

Tampa, Florida, United States

Bloomington, Illinois, United States

Chicago, Illinois, United States

Indianapolis, Indiana, United States

Lexington, Kentucky, United States

Louisville, Kentucky, United States

Marrero, Louisiana, United States

Shreveport, Louisiana, United States

Omaha, Nebraska, United States

New York, New York, United States

Raleigh, North Carolina, United States

Winston-Salem, North Carolina, United States

Halifax, Nova Scotia, Canada

Oswego, Ohio, United States

Columbus, Ohio, United States

Cleveland, Ohio, United States

Medford, Oregon, United States

Saskatoon, Saskatchewan, Canada

San Antonio, Texas, United States

Houston, Texas, United States

Dallas, Texas, United States

Norfolk, Virginia, United States

Burke, Virginia, United States

Charleston, West Virginia, United States

Starting date: February 2001
Ending date: July 2002
Last updated: June 19, 2008