Safety and Tolerability Study of Levalbuterol HFA Compared to Racemic Albuterol HFA in Subjects With Asthma

Exclusion Criteria

• •Female subject who is pregnant or lactating.
• •Subject who has 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 starting study visits before 9 AM.
• •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 4 weeks prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of 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 administration is contraindicated.
• •Subject with currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 12 months prior to study start.
• •Subject with a history of cancer (exception: basal cell carcinoma in remission).
• •Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders.
• •Subject with a 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.
• •Subject with a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis.
• •Subject who has suffered from a clinically significant upper or lower respiratory tract infection in the 3 weeks prior to study start.
• •Subject with unstable asthma; or who have had a change in asthma therapy; or a visit to the Emergency Department or hospital for worsening asthma within 4 weeks.
• •Subject who is a staff member or relative of a staff member.