Completed

An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma

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What is being tested

levalbuterol tartrate MDI

+ racemic albuterol MDI

+ Placebo

Drug
Who is being recruted

Asthma+6

+ Bronchial Diseases

+ Hypersensitivity

Over 12 Years
+24 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: May 2002
See protocol details

Summary

Principal SponsorSumitomo Pharma America, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2002

Actual date on which the first participant was enrolled.

This was a Phase III, multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group study of up to 9 weeks in duration. Seven days of QID single-blind placebo administration (via MDI) was followed by 56 days of QID double-blind active treatment. Following the run-in period, each subject was randomized to one of the following three treatments: levalbuterol HFA MDI 90 mcg (2 actuations of 45 mcg), racemic albuterol HFA MDI 180 mcg (2 actuations of 90 mcg), or placebo (2 actuations). Subjects were randomized in a 2:1:1 ratio of levalbuterol to racemic albuterol to placebo. In order to maintain blinding of the device, a placebo dose was administered with each treatment. 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.

Official TitleAn Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older With Asthma
NCT00073827
Principal SponsorSumitomo Pharma America, Inc.
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

445 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 12 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AsthmaBronchial DiseasesHypersensitivityHypersensitivity, ImmediateImmune System DiseasesLung DiseasesLung Diseases, ObstructiveRespiratory HypersensitivityRespiratory Tract Diseases

Criteria

9 inclusion criteria required to participate
Willing and able to comply with the study procedures and visit schedules
Male or female, at least 12 years of age
Female subjects 12-60 years of age must have a negative serum pregnancy test at study start.
Women of child bearing potential must be using an acceptable method of birth control
Show More Criteria
15 exclusion criteria prevent from participating
Female subject who is pregnant or lactating
Have participated in an investigational drug study within 30 days prior to study start, or who is currently participating in another clinical trial
Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM
Subject who has travel commitments during the study that would interfere with trial measurements or compliance
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
levalbuterol MDI 90 mcg QID

Group II

Active Comparator
racemic albuterol MDI 180 mcg QID

Group III

Placebo
Placebo MDI QID

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 63 locations

Suspended

Alabama Asthma and Allergy Center

Homewood, United StatesOpen Alabama Asthma and Allergy Center in Google Maps
Suspended

MDC Research

Mobile, United States
Suspended

Integrated Research Group

Corona, United States
Suspended

Allergy & Asthma Medical Group of Diablo Valley, Inc.

Danville, United States
Completed63 Study Centers