Vincken Walter, Dewberry Helen, Moonen Diane
Respiratory Division, Academic Hospital, University of Brussels, Brussels, Belgium.
J Asthma. 2003 Sep;40(6):721-30. doi: 10.1081/jas-120023495.
Respimat (RMT) soft mist inhaler (SMI) is a novel, propellant-free alternative to chlorofluorocarbon metered-dose inhalers (CFC-MDIs). The aim of this study was to evaluate the safety and establish the equipotent dose of fenoterol delivered by RMT SMI vs. a conventional MDI.
Double-blind, randomized, crossover, comparative study between fenoterol inhaled via RMT (either 50 microg/actuation, RMT50; or 100 microg/actuation. RMT100) and MDI (100 microg/actuation; MDI100).
A total of 41 asthma patients received cumulative doses of fenoterol 600 microg (RMT50) or 1200 microg (RMT100 and MDI100) on 3 test days.
The bronchodilator response (forced expiratory volume in 1 second [FEV1]) was considered therapeutically equivalent (i.e., noninferior) if the 95% confidence intervals for the difference in their mean changes from baseline were within limits of +/- 0.15L. Systemic exposure was evaluated from plasma fenoterol levels. Adverse events (AEs) were recorded. RMT50 and RMT100 produced noninferior bronchodilatation to MDI100 from 30minutes after the first dose. RMT50 showed equivalent safety and tolerability to MDI100, whereas RMT100 produced a higher incidence of AEs, a significantly greater plasma potassium reduction and a significant increase in pulse rate. Fenoterol plasma levels were twice as high with RMT100 as with RMT50 or MDI100. CONCLUSIONS; The nominal dose of fenoterol administered via RMT SMI can be at least halved to achieve equivalent efficacy, safety, and tolerability to a MDI.
Respimat（RMT）软雾吸入器（SMI）是一种新型的、不含推进剂的氯氟烃定量吸入器（CFC-MDI）替代品。本研究的目的是评估RMT SMI与传统MDI递送的非诺特罗的安全性并确定等效剂量。
通过RMT（每次喷雾50微克，RMT50；或每次喷雾100微克，RMT100）和MDI（每次喷雾100微克；MDI100）吸入非诺特罗的双盲、随机、交叉、对照研究。
总共41名哮喘患者在3个测试日接受了累积剂量的非诺特罗600微克（RMT50）或1200微克（RMT100和MDI100）。
如果从基线开始其平均变化差异的95%置信区间在±0.15L范围内，则支气管扩张反应（一秒用力呼气量[FEV1]）被认为具有治疗等效性（即非劣效性）。从血浆非诺特罗水平评估全身暴露情况。记录不良事件（AE）。RMT50和RMT100在首次给药后30分钟产生的支气管扩张作用不劣于MDI100。RMT50显示出与MDI100相当的安全性和耐受性，而RMT100产生的不良事件发生率更高，血浆钾降低幅度明显更大，脉搏率显著增加。RMT100的非诺特罗血浆水平是RMT50或MDI100的两倍。结论：通过RMT SMI给药的非诺特罗的标称剂量至少可以减半，以实现与MDI相当的疗效、安全性和耐受性。
