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Safety and Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Pediatrics Subjects With Asthma

NCT00684866 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2012-02-22

No results posted yet for this study

Summary

The purpose of this study is to compare the safety and tolerability of levalbuterol HFA metered dose inhaler (MDI) versus racemic albuterol HFA MDI in pediatric subjects 4-11 years of age with asthma

Conditions

Interventions

DRUG

Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI

(a) Subjects will receive both treatments: (a) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses); followed by (b) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses)

DRUG

Racemic Albuterol followed by levalbuterol HFA MDI

(a) Subjects will receive both treatments: (a) racemic albuterol HFA MDI; 90 micrograms (16 cumulative doses) followed by (b) levalbuterol HFA MDI; 45 micrograms (16 cumulative doses)

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
4 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-01-31
Primary Completion
2003-07-31
Completion
2003-07-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00684866 on ClinicalTrials.gov