BACKGROUND:Evidence has been provided that high-dose indacaterol (300 μg) can reduce lung hyperinflation in moderate-to-severe chronic obstructive pulmonary disease (COPD). AIM:To study whether low-dose indacaterol (150 μg) also reduces lung hyperinflation in comparison with the recommended dose of tiotropium (18 μg) in moderate COPD. METHODS:This was a multicenter, randomized, blinded, 3-period cross-over, placebo-controlled study. Spirometry and lung volumes were measured before and 30, 60, 120, 180 and 240 min after the administration of single-doses of indacaterol, tiotropium, or placebo. The primary end-point was the change in peak inspiratory capacity (IC). The area under the 4-h curve (AUC(0-4)) for IC, 1-s forced expiratory volume (FEV(1)) and forced vital capacity (FVC) were secondary variables. RESULTS:49 patients completed the study. On average, peak IC and AUC(0-4) for IC were significantly greater after indacaterol than placebo by 177 mL (p = 0.007) and 142 mL (p = 0.001), respectively. Differences in peak IC and AUC(0-4) for IC between tiotropium and placebo were 120 mL (p = 0.07) and 85 mL (p = 0.052), respectively. Differences between indacaterol and tiotropium were statistically insignificant. Peak IC increased by >20% in 12 patients with indacaterol and 9 with tiotropium (p = 0.001), and by >30% in 8 patients with indacaterol and 3 with tiotropium (p = 0.001). The effects of indacaterol and tiotropium on FEV(1) and FVC were statistically significant vs placebo. CONCLUSIONS:Low-dose indacaterol has a bronchodilator effect that is similar to the recommended dose of tiotropium, but it is slightly superior in reducing lung hyperinflation. TRIAL REGISTRATION:ClinicalTrials.gov number: NCT00999908.

译文

背景:已有证据表明,大剂量茚达特罗(300μg)可以减少中重度慢性阻塞性肺疾病(COPD)中的肺过度充气。
目的:研究与中度COPD推荐剂量的噻托溴铵(18μg)相比,低剂量茚达特罗(150μg)是否还能减少肺部过度充气。
方法:这是一项多中心,随机,双盲,三期交叉,安慰剂对照的研究。在单次茚达特罗,噻托溴铵或安慰剂给药之前和之后30、60、120、180和240分钟测量肺活量和肺活量。主要终点是峰值吸气量(IC)的变化。次要变量是IC的4小时曲线下面积(AUC(0-4)),1秒强迫呼气量(FEV(1))和强迫肺活量(FVC)。
结果:49例患者完成了研究。平均而言,茚达特罗治疗后IC的峰值IC和AUC(0-4)分别比安慰剂高177 mL(p = 0.007)和142 mL(p = 0.001)。噻托溴铵和安慰剂之间IC的峰IC和AUC(0-4)的差异分别为120 mL(p = 0.07)和85 mL(p = 0.052)。茚达特罗和噻托溴铵之间的差异在统计学上不显着。在12例茚达特罗和9例噻托溴铵患者中,IC峰值增加> 20%,在8例茚达特罗和3例噻托溴铵患者中,IC增加> 30%(p = 0.001)。与安慰剂相比,茚达特罗和噻托铵对FEV(1)和FVC的影响具有统计学意义。
结论:低剂量茚达特罗具有与推荐剂量噻托溴铵相似的支气管扩张剂作用,但在减少肺过度充气方面稍有优势。
试用注册:ClinicalTrials.gov编号:NCT00999908。

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