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

Sponsor:	Sunovion
Information provided by:	Sunovion
ClinicalTrials.gov Identifier:	NCT00685126

Purpose

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.

Condition	Intervention	Phase
Reactive Airways Disease (RAD)	Drug: Levalbuterol HCl Inhalation Solution Drug: Albuterol HCl Inhalation Solution	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
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

Resource links provided by NLM:

Drug Information available for: Albuterol Levalbuterol hydrochloride Albuterol sulfate Levalbuterol tartrate

U.S. FDA Resources

Further study details as provided by Sunovion:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to meet discharge criteria or clinical decision to discharge. [ Time Frame: Days 0-7 ] [ Designated as safety issue: No ]
Time to maximum decrease in Respiratory Status Scale© total score. [ Time Frame: Days 0-7 ] [ Designated as safety issue: No ]
Individual Respiratory Status Scale© items. [ Time Frame: Days 0-7 ] [ Designated as safety issue: No ]
Time to hospitalization. [ Time Frame: Days 0-7 ] [ Designated as safety issue: No ]
Rate of hospitalization. [ Time Frame: Days 0-7 ] [ Designated as safety issue: No ]

Enrollment:	117
Study Start Date:	February 2001
Study Completion Date:	July 2002
Primary Completion Date:	July 2002 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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).	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 Other Names: Xopenex UDV Xopenex Inhalation Solution R-albuterol
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).	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 Other Names: Xopenex UDV Xopenex Inhalation Solution R-albuterol
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).	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 Other Names: Ventolin RS-albuterol

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 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.

Eligibility

Ages Eligible for Study:	up to 48 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00685126

Show 34 Study Locations

Sponsors and Collaborators

Sunovion

More Information

No publications provided

Responsible Party:	Xopenex Medical Director, Sunovion Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00685126 History of Changes
Other Study ID Numbers:	051-033
Study First Received:	May 23, 2008
Last Updated:	November 1, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sunovion:

RAD
Reactive Airways Disease
Levalbuterol
Racemic albuterol

Additional relevant MeSH terms:

Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases
Albuterol
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Adrenergic beta-2 Receptor Agonists

Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents

ClinicalTrials.gov processed this record on February 09, 2012