Study of Levalbuterol and Racemic Albuterol in Pediatric Subjects With Reactive Airways Disease (RAD)

Reactive Airways Disease (RAD) Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00685126
• Other study ID #: 051-033
• Status: Completed
• Phase: Phase 3
• First received: May 23, 2008
• Last updated: February 21, 2012
• Start date: February 2001
• Est. completion date: July 2002

Study information

• Verified date: February 2012
• Source: Sunovion
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: July 2002
• Est. primary completion date: July 2002
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 48 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchial Hyperreactivity
• Reactive Airways Disease (RAD)

Intervention

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
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunovion

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum decrease in Respiratory Status Scale© total score		Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged	No
Secondary	Time to meet discharge criteria or clinical decision to discharge.		Days 0-7	No
Secondary	Time to maximum decrease in Respiratory Status Scale© total score.		Days 0-7	No
Secondary	Individual Respiratory Status Scale© items.		Days 0-7	No
Secondary	Time to hospitalization.		Days 0-7	No
Secondary	Rate of hospitalization.		Days 0-7	No