Anzueto Antonio, Wise Robert, Calverley Peter, Dusser Daniel, Tang Wenbo, Metzdorf Norbert, Dahl Ronald
Pulmonary/Critical Care, University of Texas Health Science Center, and South Texas Veterans Health Care System, 111E, 7400 Merton Minter Blvd, San Antonio, TX, 78229, USA.
Johns Hopkins University School of Medicine, Baltimore, MD, USA.
Respir Res. 2015 Sep 15;16(1):107. doi: 10.1186/s12931-015-0269-4.
Tiotropium Safety and Performance in Respimat® (TIOSPIR®) compared the safety and efficacy of tiotropium Respimat® and tiotropium HandiHaler® in patients with chronic obstructive pulmonary disease (COPD). A prespecified spirometry substudy compared the lung function efficacy between treatment groups.
TIOSPIR® was a large-scale, long-term (2.3-year), event-driven, randomized, double-blind, parallel-group trial of 17,135 patients with COPD. In the spirometry substudy, trough forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) were measured at baseline and every 24 weeks for the duration of the trial.
The substudy included 1370 patients who received once-daily tiotropium Respimat® 5 μg (n = 461), 2.5 μg (n = 464), or tiotropium HandiHaler® 18 μg (n = 445). Adjusted mean trough FEV1 (average 24-120 weeks) was 1.285, 1.258, and 1.295 L in the Respimat® 5 μg, 2.5 μg, and HandiHaler® 18 μg groups (difference versus HandiHaler® [95 % CI]: -10 [-38, 18] mL for Respimat® 5 μg and, -37 [-65, -9] mL for Respimat® 2.5 μg); achieving noninferiority to tiotropium HandiHaler® 18 μg for tiotropium Respimat® 5 but not for 2.5 μg (prespecified analysis). Adjusted mean trough FVC was 2.590, 2.544, and 2.593 L in the Respimat® 5 μg, 2.5 μg, and HandiHaler® 18 μg groups. The rates of FEV1 decline over 24 to 120 weeks were similar for the three treatment arms (26, 40, and 34 mL/year for the tiotropium Respimat® 5-μg, 2.5-μg, and HandiHaler® 18-μg groups). The rate of FEV1 decline in GOLD I + II patients was greater than in GOLD III + IV patients (46 vs. 23 mL/year); as well as in current versus ex-smokers, in patients receiving combination therapies at baseline versus not, and in those experiencing an exacerbation during the study versus not.
The TIOSPIR® spirometry substudy showed that tiotropium Respimat® 5 μg was noninferior to tiotropium HandiHaler® 18 μg for trough FEV1, but Respimat® 2.5 μg was not. Tiotropium Respimat® 5 μg provides similar bronchodilator efficacy to tiotropium HandiHaler® 18 μg with comparable rates of FEV1 decline. The rate of FEV1 decline varied based on disease severity, with a steeper rate of decline observed in patients with moderate airway obstruction.
NCT01126437.
噻托溴铵Respimat®吸入装置的安全性和性能（TIOSPIR®）研究比较了噻托溴铵Respimat®吸入装置和噻托溴铵HandiHaler®吸入装置在慢性阻塞性肺疾病（COPD）患者中的安全性和疗效。一项预先设定的肺功能测定亚研究比较了各治疗组之间的肺功能疗效。
TIOSPIR®是一项针对17135例COPD患者的大规模、长期（2.3年）、事件驱动、随机、双盲、平行组试验。在肺功能测定亚研究中，在基线时以及试验期间每24周测量一次1秒用力呼气容积（FEV1）谷值和用力肺活量（FVC）。
该亚研究纳入了1370例患者，他们分别接受每日一次的噻托溴铵Respimat® 5μg（n = 461）、2.5μg（n = 464）或噻托溴铵HandiHaler® 18μg（n = 445）治疗。Respimat® 5μg组、2.5μg组和HandiHaler® 18μg组调整后的FEV1谷值均值（24至120周平均值）分别为1.285L、1.258L和1.295L（与HandiHaler®相比的差异[95%CI]：Respimat® 5μg组为-10[-38,18]mL，Respimat® 2.5μg组为-37[-65,-9]mL）；噻托溴铵Respimat® 5μg组达到了非劣效于噻托溴铵HandiHaler® 18μg组，但2.5μg组未达到（预先设定的分析）。Respimat® 5μg组、2.5μg组和HandiHaler® 18μg组调整后的FVC谷值均值分别为2.590L、2.544L和2.593L。三个治疗组在24至120周期间FEV1下降速率相似（噻托溴铵Respimat® 5μg组、2.5μg组和HandiHaler® 18μg组分别为26mL/年、40mL/年和34mL/年）。全球慢性阻塞性肺疾病倡议（GOLD）I + II级患者的FEV1下降速率大于GOLD III + IV级患者（46 vs. 23 mL/年）；当前吸烟者与既往吸烟者相比、基线时接受联合治疗的患者与未接受联合治疗的患者相比、研究期间发生病情加重的患者与未发生病情加重的患者相比，情况均如此。
TIOSPIR®肺功能测定亚研究表明，噻托溴铵Respimat® 5μg在FEV1谷值方面非劣效于噻托溴铵HandiHaler® 18μg，但Respimat® 2.5μg并非如此。噻托溴铵Respimat® 5μg与噻托溴铵HandiHaler® 18μg具有相似的支气管扩张疗效，FEV1下降速率相当。FEV1下降速率因疾病严重程度而异，中度气道阻塞患者的下降速率更为陡峭。
NCT01126437。
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