哮喘联盟

   摘要   
   前列腺素D2 (PGD2) 受体CRTH2在气道变应性炎症中发挥作用。BI 671800是一种CRTH2的拮抗剂。有2个独立的试验评估了BI 671800对于哮喘的疗效。在这2个试验中，哮喘患者分别接受单一BI 671800治疗或BI 671800联合吸入性皮质类固醇(ICS)治疗。在本研究中，对于未使用吸入皮质类固醇的哮喘患者，分别给予BI 671800 (50，200或400 mg) bid、丙酸氟替卡松(220 μg)bid和安慰剂bid(试验1)；对于接受吸入性氟替卡松(88 μg bid)治疗的哮喘患者，分别给予BI 671800 400 mg bid、孟鲁斯特 10 mg qd和安慰剂bid (试验2)。两项试验观察的主要终点是一秒用力呼气量(FEV1)谷值预期百分比自基线水平的变化。在试验1中，经过为期六周的治疗后，相较于安慰剂组，BI 671800 50、200、400 mg bid组和丙酸氟替卡松 220 μg bid组主要终点的校正后平均治疗差异分别是3.08% (SE=1.65%，p = 0.0311)、3.59% (SE=1.60%，p = 0.0126)、3.98% (SE=1.64%，p = 0.0078 )和8.62% (SE=1.68%，p < 0.0001)。在试验2中，相较于安慰剂组，BI 671800 400 mg bid组和孟鲁斯特组校正后的平均 FEV1 治疗差异分别为3.87%(SE=1.49%，p=0.0050)和2.37% (SE=1.57%，p = 0.0657)。这些结果表明：BI 671800与未使用/使用吸入皮质类固醇患者的FEV1的较小改善密切相关。
 

（苏欣 审校）
PulmPharmacolTher. 2015Apr8.pii:S1094-5539(15)00038-3.doi:10.1016/j.pupt.2015.03.003. [Epub ahead of print]

 

Efficacy of BI 671800, an oral CRTH2 antagonist, in poorly controlled asthma as sole controller and in the presence of inhaled corticosteroid treatment.
 

Hall IP1, Fowler AV2, Gupta A3, Tetzlaff K4, Nivens MC5, Sarno M6, Finnigan HA7, Bateman ED8, Rand Sutherland E9.
 

Abstract
The prostaglandin D2 (PGD2) 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 μg) all given twice daily (bid) were compared with bid placebo in symptomatic controller-naïve 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 μg 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 μg 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-naïve asthma patients, and in patients on ICS.
 

PulmPharmacolTher. 2015Apr8.pii:S1094-5539(15)00038-3.doi:10.1016/j.pupt.2015.03.003. [Epub ahead of print]