This is a research study designed to compare the single-dose efficacy of albuterol-hydrofluoroalkane-breath-actuated inhaler (HFA-BAI) and albuterol-HFA-metered-dose inhaler (MDI) in asthmatics with poor inhaler coordinating abilities.

Inclusion Criteria:

• Asthma of a minimum of 6 months duration
• Participants who demonstrate poor inhalation/actuation coordination when evaluated at screening utilizing the Aerosol Inhalation Monitor (AIM, Vitalograph) prior to any training and following training in 3 consecutive attempts
• 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 peak expiratory flow (PEF) determinations and report scores on diaries
• Can tolerate withdrawal of applicable medications for qualification at screening
• Otherwise healthy individuals
• Non-smokers for at least 2 years prior to the screening visit

Exclusion Criteria:

• Allergy or sensitivity to albuterol
• Exposure to investigational drugs within 30 days prior to the screening visit
• Continuous treatment with beta-blockers, monoamine oxidase (MAO) inhibitors, tricyclic antidepressants, and/or systemic corticosteroids
• Treated with oral or injectable corticosteroids within the 6 weeks prior to the screening visit
• The prescribed dose regimen of any required antileukotrienes, inhaled corticosteroids and/or inhaled cromolyn and/or nedocromil had not been stable for at least 4 weeks prior to the screening visit
• 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 3 months prior to the screening visit
• An upper respiratory tract infection and/or sinusitis associated with exacerbation of asthma that is unresolved 3 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 Note: Other inclusion and exclusion criteria may apply.

Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.