Comparative Effectiveness of a Breath-operated Albuterol Inhaler in Asthma Patients With Poor Inhaler Technique

Comparison of Single-dose Efficacy of Albuterol-HFA-BOI and Albuterol-HFA-MDI in Asthmatics With Poor Inhaler Coordinating Ability

This study was designed to examine the effectiveness of a breath-operated albuterol inhaler in asthma patients who have difficulty using their standard "press-and-breathe" inhaler.

This was a single-center, randomized, open-label, active-controlled, 2-period, 2-sequence, single dose-dose, crossover comparison of the ability of Albuterol BOI-HFA to produce bronchodilation relative to that produced by to albuterol MDI-HFA in at least 12 asthmatics with poor inhaler coordinating ability.

Inclusion Criteria:

• Asthma diagnosed ≥6 months prior and stable for 4 weeks prior to screening
• Poor inhaler coordination as assessed at screening
• Reversible bronchoconstriction (≥ 12% increase in FEV1)

Exclusion Criteria:

• Albuterol allergy
• Investigational drug within 30 days
• Injected corticosteroid within 6 weeks
• Requires beta-blockers, MAO inhibitors, tricyclic antidepressants, long-acting beta-blockers, steroids other than those inhaled
• Other criterial apply