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

• Status: Completed
• Trial end date: 2005-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sunovion
• Treatments: Albuterol

Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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