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

Completed · Phase 3 · Has a placebo group

Conditions studied: Asthma

In brief

The primary purpose of this study was to investigate the efficacy of levalbuterol compared to a placebo and compared to albuterol in the treatment and prevention of bronchoconstriction in adolescent and adult subjects with asthma, with all treatments administered 4 times a day (QID).

Key facts

Study ID

NCT00073827

Run by

Sumitomo Pharma America, Inc.

People needed

445

Starts

2002-05-01

Expected to finish

2003-01-01

Last updated by the study team

2012-02-22

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Have a documented diagnosis of asthma for a minimum of 6 months prior to study start
• Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or OTC asthma medication for at least 6 months prior to study start
• 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
• Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease, etc.
• Must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions, and demonstrate how to use the MiniWright PEF meter.

You may not qualify if…

• 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
• Have a history of hospitalization for asthma within 45 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery
• Have a known sensitivity to levalbuterol or racemic albuterol, or any excipients in any of these formulations
• Subject using any prescription drug with which albuterol sulfate administration is contraindicated
• Subject with currently diagnosed life-threatening asthma
• History of cancer (exception: basal cell carcinoma in remission).
• Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication
• History of substance abuse or drug abuse within 12 months preceding study start
• Subject with greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 months of study start
• Documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
• Have suffered from a clinically significant upper or lower respiratory tract infection in the 2 weeks prior to study start
• Subject who is a staff member or relative of a staff member

Where it is running

• MDC Research — Mobile, Alabama, United States
• Integrated Research Group — Corona, California, United States
• Allergy & Asthma Medical Group of Diablo Valley, Inc. — Danville, California, United States
• Radiant Research, Inc. — Encinitas, California, United States
• Allergy & Asthma Specialists Medical Group — Huntington Beach, California, United States
• Allergy, Asthma & Respiratory Care Center — Long Beach, California, United States
• Allergy Research Foundation, Inc. — Los Angeles, California, United States
• Clinical Trials of Orange County — Orange, California, United States
• Allergy Associates Medical Group — San Diego, California, United States
• Allergy & Asthma Medical Group & Research Center — San Diego, California, United States
• Allergy & Asthma Prevention & Treatment Center — San Diego, California, United States
• Allergy & Asthma Assoc. of Santa Clara Valley Research Center — San Jose, California, United States
• Bensch Research Associates — Stockton, California, United States
• Southern California Research Center — Viejo, California, United States
• National Jewish Medical & Research Center — Denver, Colorado, United States
• Clinical Research Centers of Colorado PC — Englewood, Colorado, United States
• Asthma & Allergy Associates, PC — Pueblo, Colorado, United States
• Office of Ronald Saff — Tallahassee, Florida, United States
• Aeroallergy Research Laboratories of Savannah, Inc. — Savannah, Georgia, United States
• Radiant Research Honolulu — Honolulu, Hawaii, United States
• Clinical Research Center of Indiana — Indianapolis, Indiana, United States
• Allergy & Asthma Care Specialists — Metairie, Louisiana, United States
• Northshore Medical Research — Slidell, Louisiana, United States
• University of Maryland School of Medicine — Baltimore, Maryland, United States
• Alabama Asthma and Allergy Center — Homewood, Alabama, United States

Full record on ClinicalTrials.gov

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