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

Sumitomo Pharma

Status and phase: Completed; Phase 3

Conditions: Reactive Airways Disease (RAD)

Treatments: Drug: Levalbuterol HCl Inhalation Solution; Drug: Albuterol HCl Inhalation Solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT00685126

051-033

Details and patient eligibility

About

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.

Full 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.

Enrollment: 117 patients

Sex: All

Ages: Under 48 months old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

117 participants in 3 patient groups

A

Experimental group

Description:

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).

Treatment:

Drug: Levalbuterol HCl Inhalation Solution

Drug: Levalbuterol HCl Inhalation Solution

B

Experimental group

Description:

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).

Treatment:

Drug: Levalbuterol HCl Inhalation Solution

Drug: Levalbuterol HCl Inhalation Solution

C

Active Comparator group

Description:

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).

Treatment:

Drug: Albuterol HCl Inhalation Solution