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”

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.

Study Type: Interventional

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

Study Primary Completion Date: July 2002

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

Intervention(s) in this Clinical Trial

• Drug: Levalbuterol HCl Inhalation Solution
  • Nebulized unit dose vial for inhalation, low dose (0.15 mg, 0.31 mg or 0.63 mg), adjusted for body weight
• Drug: Levalbuterol HCl Inhalation Solution
  • Nebulized unit dose vial for inhalation, high dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight
• Drug: Albuterol HCl Inhalation Solution
  • Nebulized unit dose vial for inhalation, dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: A
  • Low dose levalbuterol (0.15 mg, 0.31 mg or 0.63 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion. Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID).
• Experimental: B
  • High dose levalbuterol (0.31 mg, 0.63 mg or 1.25 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion. Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID).
• Active Comparator: C
  • Racemic albuterol (0.63, 1.25 mg or 2.5 mg); the first three doses will be delivered every 20 minutes for the first hour. Up to three additional doses may be given every 40 minutes thereafter. Additional doses may be administered at the investigator's discretion. Period II: Double blind, active-treatment period following discharge from the Emergency Department or Physician's Office. Subject will receive TID double-blind dosing. Period III: Double blind, active-treatment period following Visit 2. Subjects will receive double-blind dosing at the discretion of the investigator (PRN to TID).

Primary Measures

• Maximum decrease in Respiratory Status Scale© total score
  • Time Frame: Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged
    Safety Issue?: No

Secondary Measures

• Time to meet discharge criteria or clinical decision to discharge.
  • Time Frame: Days 0-7
    Safety Issue?: No
• Time to maximum decrease in Respiratory Status Scale© total score.
  • Time Frame: Days 0-7
    Safety Issue?: No
• Individual Respiratory Status Scale© items.
  • Time Frame: Days 0-7
    Safety Issue?: No
• Time to hospitalization.
  • Time Frame: Days 0-7
    Safety Issue?: No
• Rate of hospitalization.
  • Time Frame: Days 0-7
    Safety Issue?: No

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: 48 Months

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Sepracor, Inc.

Information obtained from ClinicalTrials.gov on August 21, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00685126

Study ID Number: 051-033

ClinicalTrials.gov Identifier: NCT00685126

Health Authority: United States: Food and Drug Administration