OBJECTIVE:To assess the bronchodilator efficacy, safety and tolerability of indacaterol, a novel, once-daily inhaled beta(2)-agonist bronchodilator, in patients with chronic obstructive pulmonary disease (COPD). METHODS:This crossover, double-blind, double-dummy study was conducted to evaluate the 24-h bronchodilator effect of a range of single doses of indacaterol (150 microg, 300 microg and 600 microg), given in the morning via single-dose dry powder inhaler (SDDPI) in subjects with COPD, compared with placebo and with the daily therapeutic dose of formoterol (two 12 microg doses 12 h apart, via an SDDPI). Tolerability and safety were also assessed. RESULTS:Fifty-one subjects with moderate-to-severe COPD received each of the five treatments on separate study days in randomised sequence. The 24-h trough FEV(1) (primary endpoint; mean [95% CI]) was 1.46 (1.43, 1.49) L with indacaterol 600 microg (p < 0.001 vs. placebo, p < 0.01 vs. formoterol, p < 0.05 vs. indacaterol 150 microg), 1.45 (1.42, 1.48) L with indacaterol 300 microg (p < 0.001 vs. placebo, p < 0.05 vs. formoterol), 1.42 (1.39, 1.45) L with indacaterol 150 microg (p < 0.001 vs. placebo), 1.41 (1.38, 1.43) L with formoterol (p < 0.001 vs. placebo) and 1.28 (1.25, 1.31) L with placebo. All treatments were well tolerated and there was little effect on serum potassium, blood glucose or QTc interval. CONCLUSION:All doses of indacaterol were effective in providing 24-h bronchodilation and were well-tolerated in subjects with COPD. The bronchodilator efficacy of indacaterol (150, 300 and 600 microg) at 24 h post-dose was at least as efficacious as formoterol 12 microg twice daily.

译文

目的:评估每日一次吸入的β(2)-激动剂支气管扩张剂茚达特罗在慢性阻塞性肺疾病(COPD)患者中的支气管扩张剂疗效,安全性和耐受性。
方法:这项交叉,双盲,双模拟研究旨在评估早晨通过单剂量给予的茚达特罗(150微克,300微克和600微克)单剂量范围的24小时支气管扩张剂作用。与安慰剂和每日治疗剂量的福莫特罗相比,COPD患者使用干粉吸入器(SDDPI)(通过SDDPI,相隔12小时服用两次12微克剂量)。还评估了耐受性和安全性。
结果:51名中度至重度COPD受试者在随机的独立研究日中接受了五种治疗中的每一种。 24小时谷值FEV(1)(主要终点;平均[95%CI])为1.46(1.43,1.49)L,茚达特罗600微克(与安慰剂相比p <0.001,与福莫特罗相比p <0.01,p <0.05与茚达特罗150微克相比),1.45(1.42,1.48)L与茚达特罗300微克(p <0.001对安慰剂,p <0.05对福莫特罗),1.42(1.39,1.45)L与茚达特罗150微克(p <0.001 vs.安慰剂),1.41(1.38,1.43)L与福莫特罗(p <0.001 vs.安慰剂)和1.28(1.25,1.31)L与安慰剂。所有治疗均耐受良好,对血钾,血糖或QTc间隔影响不大。
结论:所有剂量的茚达特罗均能有效地提供24小时支气管扩张作用,并且在COPD患者中具有良好的耐受性。茚达特罗(150、300和600微克)在给药后24小时的支气管扩张药功效至少与每天两次两次12微克的福莫特罗一样有效。

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