• under the FEV1 percent change from visit predose curve averaged over the double-blind period [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
• peak change and peak percent change in FEV1 from visit predose to each visit [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
• peak change in FEV1 from visit predose to each visit [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
• peak percent change in FEV1 from study baseline over the double blind period [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
• time to peak change [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
• peak percent of predicted FEV1 at each visit and over the double-blind period [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
• area under the FEV1 percent change from predose curve at each visit [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
• area under the FEV1 percent change from study baseline curve at each visit and averaged over the double-blind period [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
• percent of predicted FEV1 AUC at each visit [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
• percent change in predose FEV1 from study baseline at each visit [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
• number and percent of responders [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]
• time to onset of response and duration of response [ Time Frame: Week 0, 2, 4 ] [ Designated as safety issue: No ]

Study of Daily Dosing with Levalbuterol, Racemic Albuterol, and Placebo in Pediatric Subjects with Asthma

This was a Phase III, double-blind, randomized, placebo- and active-controlled, multicenter, parallel-group study of up to 6 weeks in duration. Seven days of QID single-blind, placebo administration (via HFA MDI) was followed by 28 days of QID, double-blind treatment. A follow-up visit was required only for subjects who had, in the opinion of the investigator, a clinically significant finding at Visit 6 /ET that would put the subject at risk. A final follow up phone evaluation was conducted 7 days after the completion of Visit 6/ET.

• Drug: Levalbuterol tartrate MDI
• Drug: racemic albuterol MDI
• Drug: Placebo

• Experimental: levalbuterol MDI 90 mcg QID
• Active Comparator: racemic albuterol MDI 190 mcg QID
• Placebo Comparator: Placebo MDI QID

Inclusion Criteria

• Subject and subject's p/l guardian must be willing and able to comply with the study procedures and visit schedules
• Subject, male or female, between the ages of 4 to 11 yrs
• Female subjects 8 yrs or older will have a negative serum pregnancy test
• Must have a documented diagnosis of asthma for a minimum of 6 months prior to study start
• Must have stable baseline asthma and have been using a B-adrenergic agonist, and/or anti-asthma anti-inflammatory medication, and/or over-the-counter asthma medication for at least 6 mos. prior to study start
• Must be in good health with the exception of reversible airways disease and not suffering from any chronic condition that might affect their respiratory function
• Must have a chest X-ray that is not diagnostic of pneumonia, atelectasis, pulmonary fibrotic disease, pneumothorax, chronic obstructive pulmonary disease etc
• Subject's p/l guardian must be able to complete the diary cards and medical event calendars reliably on a daily basis, understand dosing instructions and questionnaire completion, and demonstrate how to use the MiniWright PEF meter

Exclusion Criteria

• Female subject who is pregnant or lactating
• Have participated in an investigational drug study within 30 days prior to study start, 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 9 AM
• Have travel commitments during the study that would interfere with trial measurements or compliance or both
• Have a history of hospitalization for asthma within 60 days prior to study start, or who is scheduled for in-patient hospitalization, including elective surgery during the course of 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
• Have currently diagnosed life-threatening asthma defined as a history of asthma episodes requiring intubation, associated with hypercapnia, respiratory arrest, or hypoxic seizures within 3 mos. prior to study start
• Have a history of cancer
• Subject with hyperthyroidism, diabetes, hypertension, cardiac diseases or seizure disorders that currently are not well controlled by medication or that may interfere with the successful completion of this protocol
• Have a history of substance abuse or drug abuse within 12 months preceding V1 or a positive urine drug screening at study start
• Have a documented history of bronchopulmonary aspergillosis or any form of allergic alveolitis
• Has suffered from a clinically significant upper or lower respiratory tract infection in the 2 wks prior to study start
• Have a history of cigarette smoking or use of any tobacco products
• Subject who is a relative of a staff member