Lumry W, Noveck R, Weinstein S, Barnhart F, Vandermeer A, Murray A, Reisner C
AARA Research Center, Dallas, TX 75231, USA.
Ann Allergy Asthma Immunol. 2001 Mar;86(3):297-303. doi: 10.1016/S1081-1206(10)63302-9.
Environmental imperatives to eliminate the use of chlorofluorocarbon (CFC) propellants in metered-dose inhalers have led to the development of metered-dose inhalers with the hydrofluoroalkane (HFA-134a) propellants.
To evaluate the clinical effect of switching from Ventolin CFC to Ventolin HFA and to compare the efficacy and safety of Ventolin CFC, Ventolin HFA, and placebo in patients with asthma.
Multicenter, double-blind, randomized safety and efficacy trial comparing regular use of Ventolin CFC versus Ventolin HFA versus placebo for 12 weeks in 313 patients with asthma aged 12 years and older who received Ventolin CFC during a 3-week run-in period.
Patients who were switched from Ventolin CFC to Ventolin HFA maintained pulmonary function and other measures of asthma control at levels comparable with run-in baseline. Serial pulmonary function testing demonstrated that both Ventolin treatments had significantly greater mean improvement in FEV1 over baseline than the placebo group at treatment day 1 and weeks 6 and 12 (P < .001). Both Ventolin groups had comparable pulmonary function at every visit. Predose FEV1 values were maintained or improved over time with all treatments. Treatments were well-tolerated. The adverse event profile for both Ventolin treatments was comparable with placebo. No clinically relevant effects on ECG, vital signs, or clinical laboratory tests were noted. Asthma exacerbation rates were 4% to 5% in the Ventolin groups and slightly higher (8%) in the placebo group.
Patients who were switched from Ventolin CFC to Ventolin HFA maintained comparable asthma control with a similar safety profile.
消除定量吸入器中氯氟烃（CFC）推进剂使用的环境要求促使了含氢氟烷烃（HFA-134a）推进剂的定量吸入器的研发。
评估从万托林CFC转换为万托林HFA的临床效果，并比较万托林CFC、万托林HFA和安慰剂在哮喘患者中的疗效和安全性。
一项多中心、双盲、随机安全性和疗效试验，在313名12岁及以上且在3周导入期使用万托林CFC的哮喘患者中，比较万托林CFC、万托林HFA和安慰剂常规使用12周的情况。
从万托林CFC转换为万托林HFA的患者维持了肺功能以及哮喘控制的其他指标，使其处于与导入期基线相当的水平。系列肺功能测试表明，在治疗第1天、第6周和第12周时，两种万托林治疗组的FEV1较基线的平均改善均显著大于安慰剂组（P <.001）。两个万托林组每次访视时的肺功能相当。所有治疗随着时间推移，用药前FEV1值均得以维持或改善。治疗耐受性良好。两种万托林治疗的不良事件谱与安慰剂相当。未观察到对心电图、生命体征或临床实验室检查有临床相关影响。万托林组的哮喘加重率为4%至5%，安慰剂组略高（8%）。
从万托林CFC转换为万托林HFA的患者维持了相当的哮喘控制水平，且安全性相似。
