The oral CRTh2 antagonist QAW039 (fevipiprant): A phase II study in uncontrolled allergic asthma
The oral CRTh2 antagonist QAW039 (fevipiprant): A phase II study in uncontrolled allergic asthma
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DOI：
10.1016/j.pupt.2016.06.005
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发表时间：
2016-08-01
影响因子：
3.2
通讯作者：
Beier, Jutta
中科院分区：
文献类型：
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作者：
Erpenbeck, Veit J.;Popov, Todor A.;Beier, Jutta
背景：对于常规治疗无法控制的过敏性哮喘患者，存在未满足的医疗需求。本研究的目的是收集QAW039，一种口服的趋化因子受体同源分子表达的Th2细胞（CRTh2）受体拮抗剂，用于治疗asthma.Methods的有效性和安全性数据：这是一项探索性II期，双盲，随机，安慰剂对照的多中心研究。轻度至中度不受控制的过敏性哮喘患者（N = 170）没有或停用吸入性皮质类固醇（ICS）和长效β受体激动剂（LABA），并随机（1：1）接受QAW039（500 mg每日一次）或安慰剂治疗28 day.Results：总体而言，157例患者完成了研究。在总人群中，QAW039与安慰剂之间的1秒用力呼气量谷值（FEV1）或哮喘控制问卷（ACQ）无显著差异。亚组分析表明，FEV1
Background: There is an unmet medical need for allergic asthma patients who are uncontrolled on conventional therapies. The aim of this study was to collect efficacy and safety data for QAW039, an oral chemoattractant receptor-homologous molecule expressed on Th2 cells (CRTh2) receptor antagonist, for the treatment of asthma.Methods: This was an exploratory phase II, double-blind, randomized, placebo-controlled multi-center study. Patients with mild-to-moderate uncontrolled allergic asthma (N = 170) were either without or weaned off inhaled corticosteroids (ICS) and long-acting beta-agonists (LABA) and randomized (1:1) to QAW039 (500 mg once daily) or to placebo for 28 days.Results: Overall, 157 patients completed the study. There were no significant differences between QAW039 and placebo for trough forced expiratory volume in 1 s (FEV1) or Asthma control questionnaire (ACQ) in the total population. Subgroup analyses demonstrated that patients with a FEV1