Reactive Airways Disease (RAD)
Conditions
Keywords
RAD, Reactive Airways Disease, Levalbuterol, Racemic albuterol
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.
Interventions
DRUGLevalbuterol 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
DRUGAlbuterol HCl Inhalation Solution
Nebulized unit dose vial for inhalation, dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight
Sponsors
Sumitomo Pharma America, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 48 Months
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maximum decrease in Respiratory Status Scale© total score | Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged |
Secondary
| Measure | Time frame |
|---|---|
| Time to meet discharge criteria or clinical decision to discharge. | Days 0-7 |
| Time to maximum decrease in Respiratory Status Scale© total score. | Days 0-7 |
| Individual Respiratory Status Scale© items. | Days 0-7 |
| Time to hospitalization. | Days 0-7 |
| Rate of hospitalization. | Days 0-7 |
Countries
Canada, United States
Outcome results
None listed