Pearlman D S, Rees William, Schaefer Kendyl, Huang Holly, Andrews William T
Colorado Allergy and Asthma Centers, PC, Denver, Colorado 80230, USA.
J Asthma. 2007 Nov;44(9):729-33. doi: 10.1080/02770900701595667.
Exercise-induced bronchospasm (EIB) affects up to 90% of all patients with asthma. Objective. This study evaluated the ability of levalbuterol hydrofluoroalkane (HFA) 90 mug (two actuations of 45 microg) administered via metered dose inhaler (MDI) to protect against EIB in mild-to-moderate asthmatics.
This was a randomized, double-blind, placebo-controlled, two-way cross-over study. Patients with asthma (n = 15) were > or =18 years, had a > or =6-month history of EIB, > or = 70% baseline predicted forced expiratory volume in 1 second (FEV1), and a 20% to 50% decrease in FEV(1) after treadmill exercise challenge using single-blind placebo MDI. Levalbuterol or placebo was self-administered 30 minutes before exercise. Treatment sequences were separated by a 3-to 7-day washout period. Spirometry was performed predose, 20 minutes postdose/pre-exercise, and 5, 10, 15, 30, and 60 minutes post-exercise. The primary endpoint was the maximum percent decrease in FEV1 from baseline (postdose/pre-exercise). The percentage of protected (< or = 20% decrease in post-exercise FEV1) patients was also assessed.
Levalbuterol had significantly smaller maximum percent post-exercise decrease in FEV1 compared with placebo (LS mean +/- SE; -4.8% +/- 2.8% versus -22.5% +/- 2.8%, respectively). For levalbuterol, 14/15 (93.3%) patients had < 20% decrease in post-exercise FEV1 compared with 8/15 (53.3%) for placebo (p = 0.0143). Treatment was well tolerated.
Levalbuterol HFA MDI (90 microg) administered 30 minutes before exercise was significantly more effective than placebo in protecting against EIB after a single exercise challenge and was well tolerated.
Levalbuterol HFA MDI when administered before exercise was effective in protecting adults with asthma from EIB.
运动诱发性支气管痉挛（EIB）影响高达90%的哮喘患者。目的：本研究评估通过定量吸入器（MDI）给予90微克（两次按压，每次45微克）氢氟烷烃（HFA）左沙丁胺醇预防轻至中度哮喘患者发生EIB的能力。
这是一项随机、双盲、安慰剂对照、双向交叉研究。哮喘患者（n = 15）年龄≥18岁，有≥6个月的EIB病史，基线第1秒用力呼气量（FEV1）≥预计值的70%，且在使用单盲安慰剂MDI进行跑步机运动激发后FEV1下降20%至50%。左沙丁胺醇或安慰剂在运动前30分钟自行给药。治疗序列之间有3至7天的洗脱期。在给药前、给药后20分钟/运动前以及运动后5、10、15、30和60分钟进行肺功能测定。主要终点是FEV1相对于基线（给药后/运动前）的最大下降百分比。还评估了得到保护（运动后FEV1下降≤20%）的患者百分比。
与安慰剂相比，左沙丁胺醇运动后FEV下降最大百分比显著更小（最小二乘均值±标准误；分别为-4.8%±2.8%和-22.5%±2.8%）。对于左沙丁胺醇，14/15（93.3%）的患者运动后FEV1下降<20%，而安慰剂组为8/15（53.3%）（p = 0.0143）。治疗耐受性良好。
运动前30分钟给予90微克HFA左沙丁胺醇MDI在单次运动激发后预防EIB方面显著比安慰剂更有效，且耐受性良好。
运动前给予HFA左沙丁胺醇MDI可有效保护成年哮喘患者免受EIB影响。
