Clinical trial NCT00685126: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Reactive Airways Disease (RAD)
Keywords: RAD
Reactive Airways Disease
Levalbuterol
Racemic albuterol
Lead sponsor: Sumitomo Pharma America, Inc.
Sponsor class: INDUSTRY
First posted: 2008-05-28
Enrollment: 117
Sex: ALL
Maximum age (years): 48
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Maximum decrease in Respiratory Status Scale© total score
timeFrame: Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged
Secondary outcomes:
measure: Time to meet discharge criteria or clinical decision to discharge.
timeFrame: Days 0-7
measure: Time to maximum decrease in Respiratory Status Scale© total score.
timeFrame: Days 0-7
measure: Individual Respiratory Status Scale© items.
timeFrame: Days 0-7
measure: Time to hospitalization.
timeFrame: Days 0-7
measure: Rate of hospitalization.
timeFrame: Days 0-7
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: Corona
country: United States
state: California
city: Englewood
country: United States
state: California
city: Huntington Beach
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Denver
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Lake Worth
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Bloomington
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Lexington
country: United States
state: Kentucky
city: Louisville
country: United States
state: Kentucky
city: Marrero
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Omaha
country: United States
state: Nebraska
city: New York
country: United States
state: New York
city: Raleigh
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oswego
country: United States
state: Ohio
city: Medford
country: United States
state: Oregon
city: Dallas
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Burke
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Charleston
country: United States
state: West Virginia
city: Halifax
country: Canada
state: Nova Scotia
city: Saskatoon
country: Canada
state: Saskatchewan
Study officials:
References: