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.
- 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)
- 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