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

Study Overview
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Brief Summary
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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
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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 by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Official Title
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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

Conditions
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Reactive Airways Disease (RAD)

Intervention / Treatment
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* Drug: Levalbuterol HCl Inhalation Solution
* Drug: Levalbuterol HCl Inhalation Solution
* Drug: Albuterol HCl Inhalation Solution


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 48 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>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). | Drug: Levalbuterol HCl Inhalation Solution<br>* Nebulized unit dose vial for inhalation, low dose (0.15 mg, 0.31 mg or 0.63 mg), adjusted for body weight<br>* Other names: R-albuterol;|
| Experimental: B<br>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). | Drug: Levalbuterol HCl Inhalation Solution<br>* Nebulized unit dose vial for inhalation, high dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight<br>* Other names: R-albuterol;|
| Active Comparator: C<br>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). | Drug: Albuterol HCl Inhalation Solution<br>* Nebulized unit dose vial for inhalation, dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight<br>* Other names: RS-albuterol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum decrease in Respiratory Status Scale© total score |  | Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to meet discharge criteria or clinical decision to discharge. |  | Days 0-7 | 
| Time to maximum decrease in Respiratory Status Scale© total score. |  | Days 0-7 | 
| Individual Respiratory Status Scale© items. |  | Days 0-7 | 
| Time to hospitalization. |  | Days 0-7 | 
| Rate of hospitalization. |  | Days 0-7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Levalbuterol, RAD, Reactive Airways Disease, Racemic albuterol