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Sponsored by: |
Sepracor, Inc. |
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Information provided by: | Sepracor, Inc. |
ClinicalTrials.gov Identifier: | NCT00685126 |
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: | Treatment, Randomized, Double Blind (Subject, Investigator), Parallel Assignment, Safety/Efficacy Study |
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 |
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 |
---|---|
A: Experimental
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
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B: Experimental
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
|
C: Active Comparator
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
|
A double-blind, randomized, active-controlled, multicenter, parallel-group trial of levalbuterol in pediatric subjects presenting with acute reactive airways disease.
Ages Eligible for Study: | up to 48 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Sepracor Inc. ( Xopenex Medical Director ) |
Study ID Numbers: | 051-033 |
Study First Received: | May 23, 2008 |
Last Updated: | June 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00685126 History of Changes |
Health Authority: | United States: Food and Drug Administration |
RAD Reactive Airways Disease Levalbuterol Racemic albuterol |
Neurotransmitter Agents Adrenergic beta-Agonists Adrenergic Agents Respiratory Tract Diseases Bronchial Diseases Albuterol |
Anti-Asthmatic Agents Bronchial Hyperreactivity Peripheral Nervous System Agents Bronchodilator Agents Adrenergic Agonists |
Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic Agents Adrenergic beta-Agonists Bronchial Diseases Albuterol Physiological Effects of Drugs Anti-Asthmatic Agents Reproductive Control Agents |
Adrenergic Agonists Pharmacologic Actions Respiratory Tract Diseases Tocolytic Agents Autonomic Agents Therapeutic Uses Bronchial Hyperreactivity Peripheral Nervous System Agents Bronchodilator Agents |