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Delivery of Fenoterol via Respimat^®, a Novel ‘Soft Mist’ Inhaler

2000; Karger Publishers; Volume: 67; Issue: 6 Linguagem: Inglês

10.1159/000056298

1423-0356

J.A. van Noord, Joseph J. Smeets, Jacques P.H.M. Creemers, Louis P.M. Greefhorst, Helen Dewberry, Piet J.G. Cornelissen,

Advanced Chemical Sensor Technologies

<i>Background:</i> The phase-out of chlorofluorocarbons (CFCs) for metered dose inhalers (MDIs) has prompted the development of alternative propellants and the design of propellant-free devices for inhalation therapy. <i>Objective:</i> This study was carried out to determine the dose of fenoterol inhaled from Respimat^® (RMT), a new propellant-free soft mist inhaler, which is equivalent in terms of efficacy and safety to 1 puff of either 100 or 200 µg fenoterol inhaled from a conventional CFC-MDI (Berotec^®). <i>Methods:</i> Sixty-two asthmatic patients (35 male, 27 female) with a mean baseline FEV₁ of 1.7 liters, corresponding to 55% of the predicted normal value, were randomized at two study centers to 4 of a total of 8 possible treatments: placebo; 12.5, 25, 50, 100, or 200 µg fenoterol via RMT, and 100 or 200 µg fenoterol delivered via the MDI. <i>Results:</i> Fifty-nine patients completed the study as planned. Results of the therapeutic equivalence test for the primary endpoint, average FEV₁ (AUC_0–6)/6 and for the secondary endpoint, peak FEV₁, showed that the 12.5- and 25-µg fenoterol doses administered via RMT were equivalent to the 100 µg fenoterol dose from the MDI. The 50-, 100- and 200-µg fenoterol doses delivered by RMT did not meet the criterion for therapeutic equivalence with the 100-µg dose from the MDI, and if tested for a difference would have been significantly different in favor of RMT. All 5 RMT fenoterol doses were therapeutically equivalent to the MDI 200-µg fenoterol dose. Headache, reported by 4 patients on test days and 2 patients between test days in those randomized to RMT, was the most common adverse event, but the active treatments were generally well tolerated with no dose-dependent increases in incidence or severity of adverse events observed. <i>Conclusions:</i> The results from the study suggest that safe and efficacious bronchodilation can be obtained from single-dose fenoterol administered via RMT. Use of lower absolute doses to obtain a clinically significant improvement in pulmonary function may be possible because of the increased lung deposition achievable with the novel soft mist inhaler.