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Completed

NCT Number: NCT00685126

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

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.

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Key information

Conditions

Reactive Airways Disease (RAD) Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

Up to 48 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Halifax, Nova Scotia, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levalbuterol HCl Inhalation Solution

Drug

Nebulized unit dose vial for inhalation, low dose (0.15 mg, 0.31 mg or 0.63 mg), adjusted for body weight

Other names: Xopenex UDV, Xopenex Inhalation Solution, R-albuterol

Albuterol HCl Inhalation Solution

Drug

Nebulized unit dose vial for inhalation, dose (0.31 mg, 0.63 mg or 1.25 mg), adjusted for body weight

Other names: Ventolin, RS-albuterol

Primary outcomes

  1. Maximum decrease in Respiratory Status Scale© total score

    Time frame: Day 0: Approximately 5-10 minutes after each dose until subject is admitted or discharged

Secondary outcomes

  1. Time to meet discharge criteria or clinical decision to discharge.

    Time frame: Days 0-7

  2. Time to maximum decrease in Respiratory Status Scale© total score.

    Time frame: Days 0-7

  3. Individual Respiratory Status Scale© items.

    Time frame: Days 0-7

  4. Time to hospitalization.

    Time frame: Days 0-7

  5. Rate of hospitalization.

    Time frame: Days 0-7

Sponsors and collaborators

Lead sponsor

Sumitomo Pharma America, Inc.

Industry

Registry information

Official study 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

Important dates

Study start
2001
Primary completion
2002
Study completion
2002
First posted
May 28, 2008
Registry last updated
Feb 22, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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