• rate of discontinuations due to adverse events [ Time Frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 ] [ Designated as safety issue: Yes ]
• time-to-selected adverse events (AEs with an incidence ≥5%) [ Time Frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 ] [ Designated as safety issue: Yes ]
• asthma attacks, asthma adverse events, and expanded-definition asthma events [ Time Frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 ] [ Designated as safety issue: Yes ]
• clinical laboratory values [ Time Frame: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
• vital signs (blood pressure, heart rate, respiration rate, and body temperature) [ Time Frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
• ECG parameters [ Time Frame: Weeks -1, 0, 1, 10, 11, 26, 27, 43, 44, 52, 53 ] [ Designated as safety issue: Yes ]
• physical examinations [ Time Frame: Weeks -1, 0, 26, 27, 52, 53 ] [ Designated as safety issue: No ]
• rescue medication, and daytime asthma control days [ Time Frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 ] [ Designated as safety issue: Yes ]
• FEV1, FVC, FEF25-75%, peak expiratory flow [ Time Frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 26, 27, 34, 35, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
• Asthma Quality of Life Questionnaire (AQLQ) [ Time Frame: Weeks 0, 26, 27, 52, 53 ] [ Designated as safety issue: No ]
• subject and physician global evaluations [ Time Frame: Weeks 26, 27, 52, 53 ] [ Designated as safety issue: No ]
• (S) and (R) albuterol plasma concentrations [ Time Frame: Weeks -1, 0, 10, 11, 26, 27, 43, 44, 52, 53 ] [ Designated as safety issue: No ]
• subject assessment of study inhaler device performance [ Time Frame: Weeks -1, 0, 1, 2, 3, 10, 11, 18, 19, 22, 23, 26, 27, 30, 31, 34, 35, 38, 39, 43, 44, 47, 48, 52, 53 ] [ Designated as safety issue: No ]

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.

This was a randomized, open-label, active controlled, multicenter, parallel-group safety study in subjects 12 years of age and older with asthma. Subjects of appropriate age who completed the Phase III levalbuterol HFA MDI trials (Studies 051-353 or 051-355) were eligible to participate. Studies 051-353 and 051-355, both entitled "An Efficacy and Safety Study of Levalbuterol, Racemic Albuterol and Placebo in Subjects Twelve Years of Age and Older with Asthma" were multicenter, randomized, double-blind, placebo- and active-controlled, parallel-group studies of up to nine weeks in duration (a one-week single-blind placebo run in period followed by an eight-week double-blind treatment period). Subjects who completed Studies 051 353 and 051 355 but who were not immediately eligible to rollover into the current study could also participate but only after a 30-day washout. New subjects and subjects who participated in the Phase III trials who were not immediately eligible (ie, had a >30-day washout) were considered to be de novo subjects.

Study participation included 10 study visits over a 12 month period.

• Drug: levalbuterol tartrate HFA MDI
• Drug: racemic albuterol

• Experimental: levalbuterol 90 mcg MDI QID
• Active Comparator: racemic albuterol HFA MDI 180 mcg QID

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