Completed

An Efficacy, Safety, and Tolerability Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects 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

From 4 to 11 Years
+23 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 3
Interventional
Study Start: December 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: December 1, 2002

Actual date on which the first participant was enrolled.

This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET. 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, Safety, and Tolerability Study of Daily Dosing With Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects With Asthma
NCT00073814
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

80 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.

From 4 to 11 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

8 inclusion criteria required to participate
Subject and subject's p/l guardian must be willing and able to comply with the study procedures and visit schedules
Subject, male or female, between the ages of 4 to 11 yrs
Female subjects 8 yrs or older will have a negative serum pregnancy test
Must have a documented diagnosis of asthma for a minimum of 6 months prior to study start
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
Schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9 AM
Have travel commitments during the study that would interfere with trial measurements or compliance or both
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 190 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 45 locations

Suspended

Adolescent & Pediatric Associates, PC

Montgomery, United StatesOpen Adolescent & Pediatric Associates, PC in Google Maps
Suspended

The Children's Clinic of Jonesboro, PA

Jonesboro, United States
Suspended

Integrated Research Group

Corona, United States
Suspended

Allergy & Asthma Specialists Medical Group

Huntington Beach, United States
Completed45 Study Centers