Third Department of Internal Medicine, Wakayama Medical University, Kimiidera, Wakayama, Japan.
Respir Med. 2010 Feb;104(2):228-36. doi: 10.1016/j.rmed.2009.11.011. Epub 2009 Dec 6.
To compare the efficacy and safety of tiotropium inhaled via Respimat Soft Mist Inhaler, a multidose propellant-free inhaler and HandiHaler, a single-dose dry powder inhaler, in a phase 2 study of Japanese COPD patients.
Patients with FEV(1)<or=70% predicted, FEV(1)/FVC<or=70% and a smoking history of >10 pack-years received tiotropium once daily via Respimat (5microg) and HandiHaler (18microg) for 4 weeks each in a randomised, double-blind, double-dummy, two-way crossover study. Lung function, adverse events, pharmacokinetics and safety were assessed.
Of 184 patients screened, 134 were evaluable. The trough FEV(1) response on Day 29 showed Respimat to be non-inferior to HandiHaler (mean treatment difference, 0.008L; 95% CI, -0.009 to +0.024L; p<0.001). Peak and average FEV(1) and FVC responses on Day 1 and Day 29 were very similar for the two treatments. Tiotropium plasma levels and excretion kinetics showed a similar profile of systemic exposure for the two formulations of tiotropium. Adverse events were reported by similar numbers of patients on each treatment, i.e. 27.9 and 30.6% in the Respimat and HandiHaler groups, respectively.
In Japanese patients with COPD, tiotropium Respimat 5microg and tiotropium HandiHaler 18microg showed a similar profile of efficacy, safety and pharmacokinetics.
比较噻托溴铵经 Respimat 软雾吸入器（一种多剂量无推进剂吸入器）和 HandiHaler（一种单剂量干粉吸入器）给药，在日本 COPD 患者的 2 期研究中的疗效和安全性。
FEV1<or=70%预计值、FEV1/FVC<or=70%和吸烟史>10 包年的患者接受噻托溴铵每日一次治疗，分别通过 Respimat（5μg）和 HandiHaler（18μg）给药，持续 4 周，采用随机、双盲、双模拟、两交叉设计研究。评估肺功能、不良事件、药代动力学和安全性。
在筛选的 184 例患者中，有 134 例可评估。第 29 天的谷值 FEV1 反应显示 Respimat 与 HandiHaler 相当（平均治疗差异，0.008L；95%CI，-0.009 至+0.024L；p<0.001）。第 1 天和第 29 天的峰值和平均 FEV1 和 FVC 反应在两种治疗方法中非常相似。两种噻托溴铵制剂的血浆水平和排泄动力学表现出相似的全身暴露特征。两种治疗方法报告的不良事件数量相似，即 Respimat 和 HandiHaler 组分别为 27.9%和 30.6%。
在日本 COPD 患者中，噻托溴铵 Respimat 5μg 和噻托溴铵 HandiHaler 18μg 具有相似的疗效、安全性和药代动力学特征。
