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随机对照试验
. 2012年9月27日； 367（13）：1198-207。
doi：10.1056/nejmoa1208606。 Epub 2012 Sep 2.

Tiotropium in asthma poorly controlled with standard combination therapy

Huib A M Kerstjens1, 迈克尔·恩格尔, Ronald Dahl, Pierluigi Paggiaro, Ekkehard Beck, Mark Vandewalker, Ralf Sigmund, Wolfgang Seibold, Petra Moroni-Zentgraf, Eric D Bateman
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随机对照试验

Tiotropium in asthma poorly controlled with standard combination therapy

Huib A M Kerstjenset al. N Engl J Med. .
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Background:Some patients with asthma have frequent exacerbations and persistent airflow obstruction despite treatment with inhaled glucocorticoids and long-acting beta-agonists (LABAs).

方法：In two replicate, randomized, controlled trials involving 912 patients with asthma who were receiving inhaled glucocorticoids and LABAs, we compared the effect on lung function and exacerbations of adding tiotropium (a total dose of 5 μg) or placebo, both delivered by a soft-mist inhaler once daily for 48 weeks. All the patients were symptomatic, had a post-bronchodilator forced expiratory volume in 1 second (FEV(1)) of 80% or less of the predicted value, and had a history of at least one severe exacerbation in the previous year.

Results:患者的平均基线FEV（1）为预测值的62％。平均年龄为53岁。在24周时，在两项试验中，tiotopium的峰值FEV（1）的平均变化比安慰剂大于安慰剂：试验1中的差异为86±34 ml（p = 0.01）和154±试验2中的32毫升（p <0.001）。与安慰剂相比，在试验1和2的试验1和2中，predose（槽）FEV（1）分别改善了1和2：分别为88±31 ml（P = 0.01）和111±30 mL（P <0.001）。tiotopium的加入增加了第一次严重加重的时间（282天比226天），总体上降低了21％，在严重加重的风险下（危险比，0.79； p = 0.03）。没有死亡；两组的不良事件相似。

Conclusions:In patients with poorly controlled asthma despite the use of inhaled glucocorticoids and LABAs, the addition of tiotropium significantly increased the time to the first severe exacerbation and provided modest sustained bronchodilation. (Funded by Boehringer Ingelheim and Pfizer; ClinicalTrials.gov numbers,NCT00772538和NCT00776984.).

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