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

February 21, 2012 updated by: Sunovion

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Corona, California, United States
      • Englewood, California, United States
      • Huntington Beach, California, United States
      • Long Beach, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
    • Colorado
      • Denver, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Lake Worth, Florida, United States
      • Tampa, Florida, United States
    • Illinois
      • Bloomington, Illinois, United States
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Marrero, Louisiana, United States
      • Shreveport, Louisiana, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • New York, New York, United States
    • North Carolina
      • Raleigh, North Carolina, United States
      • Winston-Salem, North Carolina, United States
    • Ohio
      • Cleveland, Ohio, United States
      • Columbus, Ohio, United States
      • Oswego, Ohio, United States
    • Oregon
      • Medford, Oregon, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Virginia
      • Burke, Virginia, United States
      • Norfolk, Virginia, United States
    • West Virginia
      • Charleston, West Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
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
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, 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
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunovion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2001

Primary Completion (Actual)

July 1, 2002

Study Completion (Actual)

July 1, 2002

Study Registration Dates

First Submitted

May 23, 2008

First Submitted That Met QC Criteria

May 23, 2008

First Posted (Estimate)

May 28, 2008

Study Record Updates

Last Update Posted (Estimate)

February 22, 2012

Last Update Submitted That Met QC Criteria

February 21, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 051-033

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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