Corren J, Nelson H, Greos L S, Bensch G, Goldstein M, Wu J, Wang S, Newman K
Allergy Research Foundation, Inc., Los Angeles, California 90023, USA.
Ann Allergy Asthma Immunol. 2001 Nov;87(5):405-11. doi: 10.1016/S1081-1206(10)62922-5.
Inhaled corticosteroids are established as maintenance therapy for persistent asthma. A new aerosol formulation of flunisolide delivers a small particle size by using a hydrofluoroalkane (HFA) propellant with a built-in spacer.
To compare efficacy and safety of two different flunisolide formulations, HFA and chlorofluorocarbon (CFC), with placebo treatment over a range of doses.
The multicenter, randomized, double-blind, placebo-controlled trial consisted of a 2-week, active run-in phase with CFC flunisolide 500 microg, twice daily, followed by 12 weeks of double-blind treatment with placebo, HFA flunisolide (85, 170, or 340 microg, twice daily), or CFC flunisolide (250, 500, or 1,000 microg, twice daily). Patients (N = 669) were nonsmokers, at least 12 years of age, with mild to moderate asthma who were being treated with inhaled corticosteroids. Outcome measures were change from baseline in forced expiratory volume in 1 second (FEV1), peak expiratory flow rate, as needed albuterol use, nocturnal awakenings, and asthma symptoms.
After 12 weeks of treatment, patients receiving 170 microg, twice daily, and 340 microg, twice daily, of HFA flunisolide showed a significant (P < 0.01) improvement in percentage increase in FEV1 (12.22% at 170 microg, twice daily, and 14.69% at 340 microg, twice daily) compared with the placebo group (5.35%). At one-third the dose of CFC flunisolide, HFA flunisolide provided similar improvement in pulmonary function versus placebo. Both formulations demonstrated comparable linear dose dependency for the change from baseline in FEV1 without any evidence of cortisol suppression. Outcome values for all seven secondary efficacy measures were numerically superior in patients receiving HFA flunisolide compared with the CFC formulation. Both formulations seemed to be safe and well tolerated.
HFA flunisolide provides comparable efficacy and safety at one-third the dose of CFC flunisolide.
吸入性糖皮质激素已被确立为持续性哮喘的维持治疗药物。一种新的氟尼缩松气雾剂制剂通过使用带有内置储雾罐的氢氟烷烃（HFA）推进剂来产生小粒径颗粒。
比较两种不同剂型的氟尼缩松（HFA和氯氟烃（CFC））与安慰剂在一系列剂量下的疗效和安全性。
这项多中心、随机、双盲、安慰剂对照试验包括一个为期2周的活性导入期，期间每日两次使用500微克的CFC氟尼缩松，随后是为期12周的双盲治疗，治疗药物为安慰剂、HFA氟尼缩松（每日两次，85微克、170微克或340微克）或CFC氟尼缩松（每日两次，250微克、500微克或1000微克）。患者（N = 669）为非吸烟者，年龄至少12岁，患有轻至中度哮喘，正在接受吸入性糖皮质激素治疗。疗效指标包括第1秒用力呼气量（FEV1）相对于基线的变化、呼气峰值流速、按需使用沙丁胺醇的情况、夜间觉醒次数和哮喘症状。
治疗12周后，每日两次接受170微克和每日两次接受340微克HFA氟尼缩松治疗的患者，其FEV1增加百分比相比安慰剂组（5.35%）有显著改善（P < 0.01）（每日两次170微克时为12.22%，每日两次340微克时为14.69%）。在CFC氟尼缩松剂量为三分之一时，HFA氟尼缩松与安慰剂相比在肺功能改善方面相似。两种制剂在FEV1相对于基线的变化方面均显示出可比的线性剂量依赖性，且无任何皮质醇抑制的证据。接受HFA氟尼缩松治疗的患者在所有七项次要疗效指标的数值上均优于接受CFC制剂治疗的患者。两种制剂似乎均安全且耐受性良好。
HFA氟尼缩松在剂量为CFC氟尼缩松三分之一时具有相当的疗效和安全性。
