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首页> 外文期刊>European Journal of Pharmacology: An International Journal >Initial assessment of single and repeat doses of inhaled umeclidinium in patients with chronic obstructive pulmonary disease: Two randomised studies
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Initial assessment of single and repeat doses of inhaled umeclidinium in patients with chronic obstructive pulmonary disease: Two randomised studies

机译：慢性阻塞性肺疾病患者单次和重复剂量吸入乌梅林定的初步评估：两项随机研究

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To characterise the safety, tolerability, pharmacodynamics (bronchodilatory effect) and pharmacokinetics of inhaled umeclidinium in patients with chronic obstructive pulmonary disease (COPD). The first investigation was a single dose, randomised, double-blind, placebo-controlled study (clinicaltrials.gov: NCT00515502) in which ipratropium bromide-sensitive patients received umeclidinium (250 μg, 500 μg, and 1000 μg), tiotropium bromide 18 μg or placebo. Patients were randomised to receive four out of five possible treatments as an incomplete block four-way cross-over. A subsequent study (clinicaltrials.gov: NCT700732472) was focused on assessment of safety, tolerability and pharmacokinetics of umeclidinium (250 μg and 1000 μg) administered once-daily for 7 days in a randomised, double-blind, placebo-controlled, parallel-group design. Of the 24 patients randomised for the single dose study, 20 completed; 31 out of 38 patients completed the repeat dose study. Most adverse events were mild-to-moderate and transient. Examination of heart rate, QTc interval, blood pressure and clinical laboratory assessments raised no concern over the safety of umeclidinium. Evidence of pharmacology was demonstrated in first study by statistically significant increases in specific airway conductance (sGaw) for up to 24 h for all active treatments compared with placebo. Increases in forced expiratory volume in 1 s were also observed. Pharmacokinetic analysis demonstrated that maximum observed plasma umeclidinium concentration (Cmax) was reached rapidly (time to Cmax: ～5-15 min) after single and repeat doses; 1.5-1.9-fold accumulation was observed after repeat-dosing. Single and repeat doses of umeclidinium were well tolerated and produced clinically relevant lung function improvements over 24 h in patients with COPD.
机译：为了表征慢性阻塞性肺疾病（COPD）患者吸入乌草碱的安全性，耐受性，药效学（支气管扩张作用）和药代动力学。第一项研究是单剂量，随机，双盲，安慰剂对照研究（clinicaltrials.gov：NCT00515502），其中对异丙托溴铵敏感的患者分别接受了乌米草定（250μg，500μg和1000μg），噻托溴铵18μg。或安慰剂。患者被随机分配接受五种可能的治疗方法中的四种，作为不完全的四通交叉治疗。随后的研究（clinicaltrials.gov：NCT700732472）的重点是评估每天一次，随机，双盲，安慰剂对照，平行治疗，每天7天服用的umeclidinium（250μg和1000μg）的安全性，耐受性和药代动力学。小组设计。在单剂量研究中随机分组的24名患者中，有20名完成了研究。 38位患者中有31位完成了重复剂量研究。大多数不良事件为轻度至中度和短暂性。对心律，QTc间隔，血压和临床实验室评估进行的检查并未引起人们对umeclidinium安全性的担忧。与安慰剂相比，所有主动治疗在长达24小时内，比气道电导率（sGaw）在统计学上均显着增加，这在第一项研究中证明了药理学证据。还观察到在1秒内强迫呼气量增加。药代动力学分析表明，单次和重复给药后，迅速达到最大观察到的血浆plasma草素浓度（Cmax）（达到Cmax的时间：约5-15分钟）。重复给药后观察到1.5-1.9倍积累。在COPD患者中，单剂量和重复剂量的umeclidinium耐受良好，并在24小时内产生了临床相关的肺功能改善。

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