Long Term Safety Study of Levalbuterol and Racemic Albuterol in Subjects Twelve Years of Age and Older With Asthma

Completed · Phase 3

Conditions studied: Asthma

In brief

The purpose of this study is to evaluate the safety of levalbuterol as compared to racemic albuterol based on the frequencies of adverse events reporting during a 12-month period of chronic dosing of adolescent and adult subjects with asthma.

Key facts

Study ID

NCT00064389

Run by

Sumitomo Pharma America, Inc.

People needed

746

Starts

2003-01-01

Expected to finish

2005-07-01

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 study procedures and visit schedules
• Females 12-60 yrs must have a negative serum pregnancy test at study start
• Women of child bearing potential must use acceptable method of birth control throughout study
• Confirmed diagnosis of asthma minimum of 6 mos. prior to study start
• Have stable baseline asthma and have been using B-adrenergic agonist, and/or anti-asthma anti-inflammatory meds, and/or OTC asthma meds. >6 mos. prior to study start
• In good health with exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
• Had chest X-ray w/in 12 mos. prior to randomization that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc.
• Subject rolling over from either Sepracor study 051-353 or 051-355 must have successfully completed the study
• Subject who is not immediately rolled over from Sepracor study 051-353 or 051-355 must wait >30 days and will be regarded as a de novo subject
• Able to complete daily diary cards and medical event calendars reliably, understand dosing instructions, demonstrate how to use the MiniWright PEF meter. Minor subjects must have a parent/legal guardian assist them during the study with these activities

You may not qualify if…

• Female who is pregnant or lactating
• Participated in investigational drug study w/in 30 days prior to study start, or currently participating in another clinical trial, other than Sepracor studies 051-353 or 051-355
• Subject who early terminated from Sepracor study 051-353 or 051-355
• Subject whose schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 10 AM
• Have travel commitments during the study that would interfere with trial measurements and/or compliance
• History of hospitalization for asthma w/in 45 days prior to study start, or scheduled for in-patient hospitalization, including elective surgery during 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 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 or may interfere with the successful completion of this protocol
• History of substance abuse or drug abuse within 12 months preceding V1
• Subject with >10 pack/yr 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

• Pulmonary Associates Research Division — Mobile, Alabama, United States
• Montgomery Pulmonary Consultants — Montgomery, Alabama, United States
• Center of Research Excellence, LLC — Oxford, Alabama, United States
• Lovelace Scientific Resources — Phoenix, Arizona, United States
• Alta Clinical Research, LLC — Tucson, Arizona, United States
• Integrated Research Group — Corona, California, United States
• Northern California Research Corp — Fair Oaks, California, United States
• Allergy, Asthma & Respiratory Care Center — Long Beach, California, United States
• Madera Family Medical Group — Madera, California, United States
• Clinical Trials of Orange County, Inc. — Orange, California, United States
• Institute of Healthcare Assessment, Inc. — San Diego, California, United States
• Westlake Medical Research, Inc. — Westlake Village, California, United States
• Office of Constantine Falliers, MD — Denver, Colorado, United States
• Office of Gary Richmond, MD — Fort Lauderdale, Florida, United States
• CNS Clinical Trials — Fort Myers, Florida, United States
• FPA Clinical Research — Kissimmee, Florida, United States
• Orlando Clinic for Asthma & Respiratory Diseases — Longwood, Florida, United States
• Allergy Sinus Asthma Research Institute — Miami, Florida, United States
• Florida Center for Alergy & Asthma Research — Miami, Florida, United States
• Orlando Clinical Research Center — Orlando, Florida, United States
• Family Allergy & Asthma Center, PC — Atlanta, Georgia, United States
• The Allergy & Asthma Clinic Research Center — Conyers, Georgia, United States
• Aeroallergy Research — Savannah, Georgia, United States
• Sneeze, Wheeze and Itch, LLC — Bloomington, Illinois, United States
• Jefferson Clinic PC — Birmington, Alabama, United States

Full record on ClinicalTrials.gov

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