Clareo Health | 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
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
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Teva Branded Pharmaceutical Products R&D, Inc.
Age
7–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
Allergy or sensitivity to albuterol
Exposure to investigational drugs within 30 days prior to the screening visit
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
