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

Exclusion Criteria

• •Subject who is expected to require any disallowed medications
• •Female subject who is pregnant or lactating
• •Subject who has participated in an investigational drug study within 30 days prior to V1, or who is currently participating in another clinical trial
• •Schedule prevents him or her from taking the first daily dose of study medication and/or starting study visits before 9AM
• •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 45 days prior to V1, or who is scheduled for in-patient hospitalization during the trial
• •Have 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
• •Subject with clinically significant abnormalities that may interfere with the metabolism or excretion of the study drug
• •Have a history of cancer (exception: basal cell carcinoma in remission)
• •Have hyperthyroidism, diabetes, hypertension, cardiac diseases, or seizure disorders not well controlled by medication or that may interfere with the successful completion of this protocol
• •Have a history of substance or drug abuse within 12 mos. preceding V1 or a positive urine drug screening at V1
• •Have greater than 10 pack year history of cigarette smoking or use of any tobacco products within 6 mos. of V1
• •Have a 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 V1
• •Have any clinically significant abnormal laboratory values
• •Have a clinically significant abnormal 12-lead ECG that may jeopardize the subject's ability to complete study
• •Subject who is a staff member or relative of a staff member