The purpose of this study is to compare the safety and tolerability of levalbuterol HFA
metered dose inhaler (MDI) versus racemic albuterol HFA MDI.
Inclusion Criteria:
- Subject, male or female, must be at least 12 years of age at the time of consent.
- Female subjects 12-60 years of age inclusive must have a negative serum pregnancy test
at study start.
- Women of child bearing potential must be using an acceptable method of birth control
throughout the study.
- Subject must have a documented diagnosis of asthma for a minimum of 6 months prior to
study start.
- Subject must be in good health with the exception of their reversible airways disease
and not suffering from any chronic condition that might affect their respiratory
function.
- Subject must have a chest X-ray or had one within 12 months prior to randomization.
- Subject must be able to complete the diary cards and medical event calendars reliably
on a daily basis, understand dosing instructions and be able to demonstrate good MDI
administration technique. Any minor subject who is not able to do this must have a
parent/legal guardian who can assist them during the study with these activities.
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.
