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

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