PURPOSE:Many asthma patients have difficulty coordinating inhalation with actuation when using “press-and-breathe” metered-dose inhalers (MDIs), resulting in reduced drug delivery to the lungs. A breath-actuated device may eliminate this issue. This study compared the single-dose efficacy of an albuterol-hydrofluoroalkane breath-actuated inhaler (A-HFA-BAI) with a conventional albuterol-hydrofluoroalkane MDI (A-HFA-MDI) in asthmatics with poor inhaler coordination.
METHODS:This single-center, randomized, open-label, active-controlled, 2-treatment, 2-period, single-dose crossover study compared bronchodilation with A-HFA-BAI vs A-HFA-MDI. Patients were ≥18 years old, demonstrated reversibility with albuterol (ie, ≥12% increase in forced expiratory volume in 1 second (FEV1)), and poor coordination (MDI activation >1 second after commencing inspiration). Subjects received 90 mcg albuterol via A-HFA-BAI and A-HFA-MDI at least 2 days apart. Specific airway conductance (SGaw) and FEV1 were determined at 30 minutes and immediately pre-dose, and 15, 30, 45, 60, and 120 minutes post-dose. The primary efficacy analysis was area-under-the-effect curve percent change from baseline SGaw over 0–2 hours post-dose (%SGaw AUEC0–2).
RESULTS:Of 14 patients completing the study, 12 were evaluable for efficacy. A-HFA-BAI produced a 29% greater increase in mean baseline-adjusted %SGaw AUEC0–2 compared with A-HFA-MDI (153% vs 119%, respectively), although the difference was not statistically significant (P=0.37). Mean %SGaw increase over time was also higher for A-HFA-BAI at all post-dose time points. Increase in %FEV1 AUEC0–2 similarly tended to favor A-HFA-BAI over A-HFA-MDI (35% vs 29%) (P=0.085). No adverse events or patient discontinuations occurred.
CONCLUSION:Compared with A-HFA-MDI, A-HFA-BAI demonstrated a trend for greater bronchodilation as indicated by %SGaw AUEC0–2 and %FEV1 AUEC0–2 in this small cohort of asthma patients with poor inhaler coordination.
CLINICAL IMPLICATIONS:Patients with poor coordination typically include the very young, elderly, arthritic, disabled, and those with poor learning ability. A-HFA-BAI may be an effective alternative for patients who cannot coordinate inhalation and actuation with conventional A-HFA-MDIs. Generally, A-HFA-BAI may also be an effective alternative for any patient using a conventional A-HFA-MDI.
DISCLOSURE:Harold Nelson, Grant monies (from industry related sources) Schering-PloughTEVACritical TherapeuticsWyethBehringer-IngelheimSepracorAstra/ZenecaAltanaGenentechNovartis; Consultant fee, speaker bureau, advisory committee, etc. Consultant Arrangements (2007–8):Genentech/NovartisAbbott LaboratoriesDey LaboratoriesCuralogicDynavax TechnologiesGlaxoSmithKlineMediciNovaSchering-PloughAstellasJohnson & JohnsonCeptionBoehringer-IngelheimDysonAstraZenecaVentiRx; Other This study was supported by IVAX Research Inc.; Product/procedure/technique that is considered research and is NOT yet approved for any purpose. The albuterol-HFA breath-actuated inhaler is currently under review with the FDA and has not yet been approved in the United States.