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

NCT00685022 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

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.

Conditions

Interventions

DRUG

Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI

1. 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) 2. Arm #A 3. Xopenex HFA MDI, albuterol HFA MDI

DRUG

Racemic Albuterol followed by levalbuterol HFA MDI

1. 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) 2. Arm #B 3. albuterol HFA MDI, Xopenex HFA MDI

Sponsors & Collaborators

  • Sumitomo Pharma America, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-06-30
Primary Completion
2003-08-31
Completion
2003-08-31

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 NCT00685022 on ClinicalTrials.gov