Bensch G, Lapidus R J, Levine B E, Lumry W, Yegen U, Kiselev P, Della Cioppa G
Allergy, Immunology, and Asthma Medical Group, Stockton, California 95207, USA.
Ann Allergy Asthma Immunol. 2001 Jan;86(1):19-27. doi: 10.1016/s1081-1206(10)62351-4.
Formoterol is a beta2-adrenergic agent which, when inhaled, produces rapid and long-lasting bronchodilatation.
The aim of this study was to compare the efficacy, safety, and tolerability of formoterol powder for inhalation delivered via the Aerolizer device with placebo and with albuterol delivered via metered-dose inhaler in patients with mild to moderate persistent asthma.
In a multicenter, double-blind, parallel-group study, 541 patients were randomized at 26 trial sites to receive either formoterol, 12 microg twice daily; formoterol, 24 microg twice daily; albuterol, 180 microg four times daily; or a placebo for 12 weeks. The effects of each treatment on lung function, asthma symptoms, and frequency of rescue albuterol use were evaluated. Adverse effects and clinical laboratory parameters were also evaluated.
The bronchodilatory effects of formoterol were rapid in onset and persisted for 12 hours. Both formoterol doses were more effective than placebo and albuterol for objective measures of lung function. Morning and evening peak expiratory flow rates were more improved with formoterol, and formoterol provided significantly greater improvements in asthma symptom scores compared with both albuterol and placebo. Overall, patients taking formoterol used significantly less rescue medication than did those taking albuterol or placebo. Nocturnal awakenings occurred less often with formoterol than with placebo or albuterol. The therapeutic effects of formoterol were maintained over the entire 12 weeks of treatment. Adverse events were similar for all treatment groups, and clinical laboratory data were unremarkable.
Rapid-onset, long-acting formoterol, administered via the Aerolizer inhaler, is an effective and safe treatment for patients with mild to moderate persistent asthma.
福莫特罗是一种β2肾上腺素能药物，吸入后可产生快速且持久的支气管扩张作用。
本研究旨在比较使用Aerolizer装置吸入的福莫特罗粉与安慰剂以及使用定量吸入器吸入的沙丁胺醇在轻至中度持续性哮喘患者中的疗效、安全性和耐受性。
在一项多中心、双盲、平行组研究中，541例患者在26个试验地点被随机分组，分别接受每日两次、每次12微克的福莫特罗；每日两次、每次24微克的福莫特罗；每日四次、每次180微克的沙丁胺醇；或安慰剂治疗12周。评估了每种治疗对肺功能、哮喘症状以及急救沙丁胺醇使用频率的影响。还评估了不良反应和临床实验室参数。
福莫特罗的支气管扩张作用起效迅速且持续12小时。两种福莫特罗剂量在肺功能客观指标方面均比安慰剂和沙丁胺醇更有效。福莫特罗使早晚呼气峰值流速改善更明显，且与沙丁胺醇和安慰剂相比，福莫特罗在哮喘症状评分方面改善更显著。总体而言，服用福莫特罗的患者使用急救药物的量明显少于服用沙丁胺醇或安慰剂的患者。与安慰剂或沙丁胺醇相比，福莫特罗导致夜间觉醒的情况更少。福莫特罗的治疗效果在整个12周治疗期间得以维持。所有治疗组的不良事件相似，临床实验室数据无异常。
通过Aerolizer吸入器给药的起效迅速、作用持久的福莫特罗是轻至中度持续性哮喘患者的一种有效且安全的治疗方法。
