Comparison of Single-Dose of Albuterol Breath Activated Inhaler Versus Albuterol Metered Dose Inhaler in Asthmatics

Inclusion Criteria:

- Male or females aged 7-70 years old

- Asthma of a minimum of 6 months duration

- Patients who demonstrate poor inhalation/actuation coordination when evaluated with
the AIM -Aerosol Inhalation Monitor.

- Reversible bronchoconstriction of >12% increase in FEV1 with a cumulative dose of 450
mcg of albuterol

- The reversibility (FEV1) of <70% following administration of the initial 90 mcg of
albuterol

- Ability to perform spirometry reproducibly

- Ability to self-perform PEF determinations and report scores on diaries

- Can tolerate withdrawal of applicable medications at screening

- Otherwise healthy individuals

- Non-smokers for at least two years

Exclusion Criteria:

- Allergy or sensitivity to albuterol

- Exposure to investigational drugs within 30 days prior to the screening visit

- Continuous treatment with Beta-blockers, MAO inhibitors, tricyclic antidepressants,
and/or systemic corticosteroids

- Treated with oral or injectable corticosteroids within the six weeks prior to the
screening visit

- Unstable dose regimen of any required antileukotrienes, inhaled corticosteroids and/or
inhaled cromolyn and/or nedocromil

- Inability to tolerate or unwillingness to comply with required washout periods for all
applicable medications

- Hospitalization for acute exacerbation of asthma more than twice in past year

- Treatment in an emergency room or hospitalization for asthmatic symptoms within three
months prior to the screening visit

- An upper respiratory tract infection and/or sinusitis associated with exacerbation of
asthma that is unresolved three weeks prior to the screening visit

- History and/or presence of any clinically significant non-asthmatic acute or chronic
disease

- Known or suspected substance abuse

- Previous enrollment in an IVAX Research-sponsored Albuterol HFA asthma study

- Other criteria apply