BACKGROUND:The combination of inhaled corticosteroids (ICS) and long-acting beta2-agonists (LABA) is recommended by treatment guidelines for the treatment of persistent asthma. Two such combination products, salmeterol/fluticasone propionate (SFC, Seretide GSK, UK) and formoterol/budesonide (FBC, Symbicort, AstraZeneca, UK) are commercially available. OBJECTIVES:The purpose of these studies was to evaluate and compare the duration of bronchodilation of both combination products up to 24 hours after a single dose. METHODS:Two randomised, double blind, placebo-controlled, crossover studies were performed. Study A was conducted in 33 asthmatic adults receiving 400-1200 mcg of budesonide or equivalent. Serial forced expiratory volume in one second (FEV1) was measured over 24 hours to determine the duration of effect of both SFC (50/100 mcg) and FBC (4.5/160 mcg). Study B was conducted in 75 asthmatic adults receiving 800-1200 mcg of budesonide or equivalent and comprised a 4 week run-in of 400 mcg bd Becotide followed by 4 weeks treatment with either SFC 50/100 mcg bd or FBC 4.5/160 mcg bd taken in a cross-over manner. Serial 24-hour FEV1 was measured after the first dose and the last dose after each 4-weeks treatment period to determine the offset of action of each treatment. RESULTS:In study A, a single inhalation of SFC and FBC produced a sustained bronchodilation at 16 hours with an adjusted mean increase in FEV1 from pre-dose of 0.22 L (95% CI 0.19, 0.35 L) for SFC and 0.25 L (95% CI 0.21, 0.37 L) for FBC, which was significantly greater than placebo for both treatments (-0.05 L; p < 0.001). In study B, the slope of decline in FEV1 from 2-24 hours post dose was -16.0 ml/hr for SFC and -14.2 ml/hr for FBC. The weighted mean AUC over 24 hours was 0.21 Lxmin and 0.22 Lxmin and mean change from pre-dose FEV1 at 12 hours was 0.21 L for SFC and 0.20 L for FBC respectively CONCLUSION:Both SFC and FBC produced a similar sustained bronchodilator effect which was prolonged beyond 12 hours post dose and was clearly measurable at 24 h.

译文

摘要背景:吸入性糖皮质激素(ICS)和长效β2-激动剂(LABA)的结合被治疗指南推荐用于持续性哮喘的治疗。两种这样的组合产品,沙美特罗/丙酸氟替卡松(SFC,英国Seretide GSK)和福莫特罗/布地奈德(FBC,Symbicort,阿斯利康,英国)可商购。
目的:这些研究的目的是评估和比较两种组合产品在单剂给药后直至24小时的支气管扩张持续时间。
方法:进行了两项随机,双盲,安慰剂对照,交叉研究。研究A在接受400-1200 mcg布地奈德或同等剂量的33位哮喘成人中进行。在24小时内测量一秒钟的连续呼气量(FEV1),以确定SFC(50/100 mcg)和FBC(4.5 / 160 mcg)的作用持续时间。研究B在75位接受800-1200 mcg布地奈德或同等水平的哮喘成年人中进行,包括4周400 mcg bd的Becotide磨合,然后用SFC 50/100 mcg bd或FBC 4.5 / 160 mcg bd进行4周治疗以交叉方式拍摄。在每4周治疗期后的第一剂和最后一剂之后,测量连续的24小时FEV1,以确定每种治疗的作用抵消。
结果:在研究A中,单次吸入SFC和FBC在16小时产生了持续的支气管扩张,FEC1的平均调整值从给药前的0.22 L(95%CI 0.19,0.35 L)和0.25 L(95 FBC的%CI 0.21,0.37 L),均显着高于两种治疗的安慰剂(-0.05 L; p <0.001)。在研究B中,从剂量后2-24小时开始,FEV1的下降斜率对于SFC为-16.0 ml / hr,对于FBC为-14.2 ml / hr。在24小时内,加权平均AUC为0.21 Lxmin和0.22 Lxmin,对于SFC,从剂量前FEV1在12小时的平均变化分别为0.21 Lx和FBC 0.20 L
结论:SFC和FBC均产生相似的持续支气管扩张药作用,给药后延长至12小时以上,并且在24 h时明显可测量。

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