Comparison of Single-Dose Efficacy of an Albuterol Breath-Actuated Inhaler (Albuterol-HFA-BAI) Versus an Albuterol Metered-Dose Inhaler (Albuterol-HFA-MDI) in Participants With Asthma
Condition: Asthma
MeSH terms: Asthma
Intervention: Albuterol-HFA-MDI; Albuterol-HFA-BAI
Intervention description: Inhalation Aerosols, 90 mcg, 1 dose per treatment period; Inhalation Aerosol (Breath-Actuated), 90 mcg, 1 dose per treatment period.
Intervention MeSH terms: Albuterol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: All
Minimum age: 7 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Asthma and Poor Coordinators of Asthma Inhalers

Summary:

      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.
    

Eligibility criteria:

        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.