Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)
NCT ID: NCT00685126
Last Updated: 2012-02-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
117 participants
INTERVENTIONAL
2001-02-28
2002-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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).
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
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).
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
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).
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
Interventions
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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
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
48 Months
ALL
No
Sponsors
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Sumitomo Pharma America, Inc.
INDUSTRY
Responsible Party
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Locations
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Little Rock, Arkansas, United States
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
Denver, Colorado, United States
Washington D.C., District of Columbia, United States
Lake Worth, Florida, United States
Tampa, Florida, United States
Bloomington, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Lexington, Kentucky, United States
Louisville, Kentucky, United States
Marrero, Louisiana, United States
Shreveport, Louisiana, United States
Omaha, Nebraska, United States
New York, New York, United States
Raleigh, North Carolina, United States
Winston-Salem, North Carolina, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Oswego, Ohio, United States
Medford, Oregon, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Burke, Virginia, United States
Norfolk, Virginia, United States
Charleston, West Virginia, United States
Halifax, Nova Scotia, Canada
Saskatoon, Saskatchewan, Canada
Countries
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Other Identifiers
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051-033
Identifier Type: -
Identifier Source: org_study_id
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