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

A Cumulative Dose Tolerability Study of Levalbuterol HFA and Racemic Albuterol HFA in Subjects Twelve Years of Age and Older With Asthma

NCT00685022•Sumitomo Pharma America, Inc.

View on ClinicalTrials.gov

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.

Detailed Description

A randomized, modified-blind active-controlled multicenter, two-way crossover study of HFA levalbuterol (without using a spacer) in subjects 12 years of age and older with asthma. 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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Subject, male or female, must be at least 12 years of age at the time of consent.
•Female subjects 12-60 years of age inclusive must have a negative serum pregnancy test at study start.
•Women of child bearing potential must be using an acceptable method of birth control throughout the study.
•Subject must have a documented diagnosis of asthma for a minimum of 6 months prior to study start.
•Subject must be in good health with the exception of their reversible airways disease and not suffering from any chronic condition that might affect their respiratory function.
•Subject must have a chest X-ray or had one within 12 months prior to randomization.
•Subject must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions and be able to demonstrate good MDI administration technique. Any minor subject who is not able to do this must have a parent/legal guardian who can assist them during the study with these activities.

Exclusion Criteria

•Female subject who is pregnant or lactating.
•Subject who has 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 starting study visits before 9 AM.
•Subject who has travel commitments during the study that would interfere with trial measurements or compliance or both.
•Subject who has a history of hospitalization for asthma within 4 weeks prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of the trial
•Subject with a known sensitivity to levalbuterol or racemic albuterol, or any of the excipients contained in any of these formulations.
•Subject using any prescription drug with which albuterol sulfate administration is contraindicated.
•Subject with currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to study start.
•Subject with a history of cancer (exception: basal cell carcinoma in remission).
•Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
+6 more criteria

Locations (3)

Encinitas, California, United States

North Dartmouth, Massachusetts, United States

St Louis, Missouri, United States

Key Dates

Start Date

June 1, 2003

Primary Completion Date

August 1, 2003

Completion Date

August 1, 2003

Last Updated

February 22, 2012

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

Levalbuterol HFA MDI followed by Racemic albuterol HFA MDI

DRUG

Racemic Albuterol followed by levalbuterol HFA MDI

DRUG

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NCT07219173

Asthma

View study

RECRUITINGNA

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NCT07486401

Asthma ExacerbationsBiomarkers / Blood+1 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 22, 2012Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma