One-year efficacy and safety of inhaled formoterol dry powder in children with persistent asthma
One-year efficacy and safety of inhaled formoterol dry powder in children with persistent asthma
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DOI：
10.1016/s1081-1206(10)61935-7
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发表时间：
2002-08-01
影响因子：
5.9
通讯作者：
Della Cioppa, G
中科院分区：
文献类型：
--
作者：
Bensch, G;Berger, WE;Della Cioppa, G
背景资料：长期疗效和安全性的福莫特罗干粉胶囊吸入在儿科asthen.Objective：我们检查了有效性吸入福莫特罗超过12个月的哮喘儿童仍然有症状，尽管抗炎治疗。方法：经过一段时间的磨合，518名患者（5 - 12岁）以双盲方式随机接受12或24 μ g福莫特罗干粉（Foradil，Novartis Pharma AG，巴塞尔，瑞士）或安慰剂，每日两次，持续12个月。药物通过吸入器（Aerolizer，Novartis Pharma AG）给药，并在抗炎治疗的基础上给予。主要变量是研究药物早晨给药后12小时内测量的1秒用力呼气容积曲线下面积。接受福莫特罗12 mug和24 mug治疗的患者在首次给药后1秒内以及治疗3个月和12个月后的用力呼气容积曲线下面积显著大于接受安慰剂的患者（P均小于或等于0.0062）。与安慰剂组相比，两种剂量的福莫特罗均能显著改善晨间和夜间给药前呼气峰流速（均P
Background: The long-term efficacy and safety of formoterol dry powder capsules for inhalation in pediatric asthma have not previously been evaluated.Objective: We examined the effectiveness of inhaled formoterol over a period of 12 months in asthmatic children who were still symptomatic despite anti-inflammatory treatment.Methods: After a run-in period, 518 patients (5 to 12 years old) were randomized in a double-blind manner to receive 12 or 24 mug formoterol dry powder (Foradil, Novartis Pharma AG, Basel, Switzerland) or placebo twice daily for 12 months. The drug was administered by inhaler (Aerolizer, Novartis Pharma AG) and was given in addition to their anti-inflammatory treatment. The primary variable was the area under the curve for forced expiratory volume in 1 second measured over 12 hours after the morning dose of study medication.Results: The area under the curve for forced expiratory volume in 1 second after the first dose of treatment and after 3 and 12 months of treatment was significantly greater for patients receiving formoterol 12 mug and 24 mug than for patients receiving placebo (all Pless than or equal to0.0062). Compared with placebo, both doses of formoterol significantly improved morning and evening premedication peak expiratory flow rate (all P