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

NCT00685126 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 117

Last updated 2012-02-22

No results posted yet for this study

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.

Conditions

  • Reactive Airways Disease (RAD)

Interventions

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

DRUG

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

DRUG

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

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Max Age
48 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2001-02-28
Primary Completion
2002-07-31
Completion
2002-07-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00685126 on ClinicalTrials.gov