Back to resultsStudy of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)
Primary Purpose
Reactive Airways Disease (RAD)
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Levalbuterol HCl Inhalation Solution
Levalbuterol HCl Inhalation Solution
Albuterol HCl Inhalation Solution
Sponsored by
About this trial
This is an interventional treatment trial for Reactive Airways Disease (RAD) focused on measuring RAD, Reactive Airways Disease, Levalbuterol, Racemic albuterol
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
A
B
C
Arm Description
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).
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).
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).
Outcomes
Primary Outcome Measures
Maximum decrease in Respiratory Status Scale© total score
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT00685126
First Posted
May 23, 2008
Last Updated
February 21, 2012
Sponsor
Sumitomo Pharma America, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00685126
Brief Title
Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)
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 Type
Interventional
2. Study Status
Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
February 2001 (undefined)
Primary Completion Date
July 2002 (Actual)
Study Completion Date
July 2002 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sumitomo Pharma America, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Reactive Airways Disease (RAD)
Keywords
RAD, Reactive Airways Disease, Levalbuterol, Racemic albuterol
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
117 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
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).
Arm Title
B
Arm Type
Experimental
Arm Description
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).
Arm Title
C
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Levalbuterol HCl Inhalation Solution
Other Intervention Name(s)
Xopenex UDV, Xopenex Inhalation Solution, R-albuterol
Intervention Description
Nebulized unit dose vial for inhalation, low dose (0.15 mg, 0.31 mg or 0.63 mg), adjusted for body weight
Intervention Type
Drug
Intervention Name(s)
Levalbuterol HCl Inhalation Solution
Other Intervention Name(s)
Xopenex UDV, Xopenex Inhalation Solution, R-albuterol
Intervention Description
Nebulized unit dose vial for inhalation, high dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight
Intervention Type
Drug
Intervention Name(s)
Albuterol HCl Inhalation Solution
Other Intervention Name(s)
Ventolin, RS-albuterol
Intervention Description
Nebulized unit dose vial for inhalation, dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Time to meet discharge criteria or clinical decision to discharge.
Time Frame
Days 0-7
Title
Time to maximum decrease in Respiratory Status Scale© total score.
Time Frame
Days 0-7
Title
Individual Respiratory Status Scale© items.
Time Frame
Days 0-7
Title
Time to hospitalization.
Time Frame
Days 0-7
Title
Rate of hospitalization.
Time Frame
Days 0-7
10. Eligibility
Sex
All
Maximum Age & Unit of Time
48 Months
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
City
Little Rock
State/Province
Arkansas
Country
United States
City
Corona
State/Province
California
Country
United States
City
Englewood
State/Province
California
Country
United States
City
Huntington Beach
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Denver
State/Province
Colorado
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Lake Worth
State/Province
Florida
Country
United States
City
Tampa
State/Province
Florida
Country
United States
City
Bloomington
State/Province
Illinois
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Indianapolis
State/Province
Indiana
Country
United States
City
Lexington
State/Province
Kentucky
Country
United States
City
Louisville
State/Province
Kentucky
Country
United States
City
Marrero
State/Province
Louisiana
Country
United States
City
Shreveport
State/Province
Louisiana
Country
United States
City
Omaha
State/Province
Nebraska
Country
United States
City
New York
State/Province
New York
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Oswego
State/Province
Ohio
Country
United States
City
Medford
State/Province
Oregon
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Burke
State/Province
Virginia
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
City
Charleston
State/Province
West Virginia
Country
United States
City
Halifax
State/Province
Nova Scotia
Country
Canada
City
Saskatoon
State/Province
Saskatchewan
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)
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