Department of Respiratory Diseases & Allergy, Aarhus University Hospital, Nørrebrogada 44, 8000 Aarhus C, Denmark.
Respir Med. 2010 Aug;104(8):1121-30. doi: 10.1016/j.rmed.2010.03.032. Epub 2010 Apr 28.
To compare the efficacy of ciclesonide (80 microg/day) with fluticasone propionate (200 microg/day) in mild to moderate persistent asthma.
Patients aged 12-75 years and previously treated with low doses of inhaled corticosteroid (fluticasone propionate 250 microg/day or equivalent) entered a 2-4 week run-in period during which only rescue medication was permitted. For inclusion into the double-blind, 24-week treatment period, patients had to show a forced expiratory volume in 1s (FEV(1)) of 61-90% predicted and a decrease in FEV(1) during run-in of >or=10%. Patients (n = 480) were randomized to ciclesonide 80 microg (ex-actuator) once daily in the evening or fluticasone propionate 100 microg (ex-valve) twice daily. The primary efficacy variable was the change from baseline in FEV(1). Secondary efficacy variables included asthma control and asthma-specific quality of life.
Both treatments significantly increased FEV(1) and other lung function variables from baseline (p < 0.0001, both groups, all variables). The least squares mean increases in FEV(1) were 0.46L (ciclesonide) and 0.52L (fluticasone propionate); non-inferiority of ciclesonide to fluticasone propionate was demonstrated (p = 0.0002, per-protocol analysis). Five patients in each group experienced asthma exacerbations. Improvements in the percent of days with asthma control (days with no asthma symptoms and no use of rescue medication) and asthma-specific quality of life were comparable between treatments.
The study confirmed similar efficacy of ciclesonide 80 microg once daily and fluticasone propionate 100 microg twice daily in mild to moderate persistent asthma. The low dose of ciclesonide was efficacious during long-term treatment. EudraCT number: 2004-001072-39.
比较环索奈德（80μg/天）与丙酸氟替卡松（200μg/天）在轻中度持续性哮喘中的疗效。
年龄在 12-75 岁之间，先前接受低剂量吸入皮质类固醇（丙酸氟替卡松 250μg/天或等效剂量）治疗的患者进入为期 2-4 周的导入期，在此期间仅允许使用急救药物。要纳入双盲、24 周治疗期，患者必须表现出用力呼气量 1 秒（FEV1）占预计值的 61-90%，并且在导入期内 FEV1 下降≥10%。患者（n=480）随机分为环索奈德 80μg（原药）每天晚上一次或丙酸氟替卡松 100μg（原药）每天两次。主要疗效变量是从基线开始的 FEV1 变化。次要疗效变量包括哮喘控制和哮喘特异性生活质量。
两种治疗方法均能显著增加 FEV1 和其他肺功能指标（p<0.0001，两组，所有变量）。FEV1 的最小二乘均值增加量分别为 0.46L（环索奈德）和 0.52L（丙酸氟替卡松）；环索奈德与丙酸氟替卡松的非劣效性得到证实（p=0.0002，按方案分析）。每组各有 5 例患者发生哮喘加重。两组之间，哮喘控制天数（无哮喘症状和无使用急救药物的天数）和哮喘特异性生活质量的改善情况相当。
该研究证实，环索奈德 80μg 每天一次和丙酸氟替卡松 100μg 每天两次在轻中度持续性哮喘中疗效相似。环索奈德的低剂量在长期治疗中有效。EudraCT 编号：2004-001072-39。
