Efficacy of BI 671800, an oral CRTH2 antagonist, in poorly controlled asthma as sole controller and in the presence of inhaled corticosteroid treatment
Efficacy of BI 671800, an oral CRTH2 antagonist, in poorly controlled asthma as sole controller and in the presence of inhaled corticosteroid treatment
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DOI：
10.1016/j.pupt.2015.03.003
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发表时间：
2015-06-01
影响因子：
3.2
通讯作者：
Sutherland, E. Rand
中科院分区：
文献类型：
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作者：
Hall, Ian P.;Fowler, Andrew V.;Sutherland, E. Rand
前列腺素D-2(PGD(2))受体CRTH2在过敏性呼吸道炎症中发挥作用。BI 671800，一种CRTH2拮抗剂，在两个单独的试验中对哮喘患者的疗效进行了评估，无论是在没有或存在吸入皮质类固醇治疗的情况下。在这项研究中，在有症状的成人哮喘患者中，BI 671800(50,200或400 mg)和丙酸氟替卡松(220mgBid)均每日两次服用(试验1)与BID安慰剂进行比较(试验1)，在吸入氟替卡松(88mgBid)的哮喘患者中，BI 671800 400 mg Bid与孟鲁司特10 mg每日1次(Qd)进行比较，并与其匹配的安慰剂Bid进行比较(试验2)。两个试验的主要终点都是谷底用力呼气量(FEV1%)预测较基线的改变。治疗6周后，在试验1中，与安慰剂相比，BI 671800 50、200和400mgBid的主要终点的调整后平均治疗差异(SE)分别为3.08%(1.65%)、3.59%(1.60%)和3.98%(1.64%)，而氟替卡松220mgBID的调整后平均治疗差异(SE)为8.62%(1.68%)(p=0.0311、p=0.0126、p=0.0078和p<；0.0001)。在试验2中，调整后的FEV1(SE)治疗与安慰剂相比，BI 671800 400 mg BID组和孟鲁司特组的平均差异分别为3.87%(1.49%)和2.37%(1.57%)(p=0.0050和p=0.0657)。这些发现表明，BI 671800与有症状的控制性哮喘患者和接受ICS治疗的患者的FEV1略有改善有关。(C)2015年提交人。爱思唯尔有限公司出版。
The prostaglandin D-2 (PGD(2)) receptor, CRTH2, plays a role in allergic airway inflammation. The efficacy of BI 671800, a CRTH2 antagonist, was assessed in 2 separate trials in patients with asthma, in either the absence or the presence of inhaled corticosteroid (ICS) therapy. In this study, BI 671800 (50, 200 or 400 mg) and fluticasone propionate (220 mu g) all given twice daily (bid) were compared with bid placebo in symptomatic controller-nave adults with asthma (Trial 1), and BI 671800 400 mg bid compared with montelukast 10 mg once daily (qd), and matching placebo bid, in patients with asthma receiving inhaled fluticasone (88 mu g bid) (Trial 2). The primary endpoint in both trials was change from baseline in trough forced expiratory volume in 1 s (FEV1) percent predicted. After 6 weeks' treatment, adjusted mean treatment differences (SE) for the primary endpoint compared with placebo in Trial 1 were 3.08% (1.65%), 3.59% (1.60%) and 3.98% (1.64%) for BI 671800 50, 200 and 400 mg bid, respectively, and 8.62% (1.68%) for fluticasone 220 mu g bid (p = 0.0311, p = 0.0126, p = 0.0078 and p < 0.0001, respectively). In Trial 2, adjusted mean FEV1 (SE) treatment differences compared with placebo were 3.87% (1.49%) for BI 671800 400 mg bid and 2.37% (1.57%) for montelukast (p = 0.0050 and p = 0.0657, respectively). These findings suggest that BI 671800 is associated with a small improvement in FEV1 in symptomatic controller-naive asthma patients, and in patients on ICS. (C) 2015 The Authors. Published by Elsevier Ltd.