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首页> 外文期刊>Clinical and experimental allergy : >Phase 2a, randomized, double‐blind, placebo‐controlled, multicentre, parallel‐group study of an H 4 4 R‐antagonist ( JNJ JNJ ‐39758979) in adults with uncontrolled asthma
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Phase 2a, randomized, double‐blind, placebo‐controlled, multicentre, parallel‐group study of an H 4 4 R‐antagonist ( JNJ JNJ ‐39758979) in adults with uncontrolled asthma

机译：2A相，随机，双盲，安慰剂控制，多期，并在具有不受控制的哮喘的成人中的H 4 4 R-拮抗剂（JNJ JNJ -39758979）的平行群体研究

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Summary Background The effects of H 4 R antagonists in preclinical asthma models support the study of antagonists of the H 4 R in the treatment of asthma in humans. JNJ ‐39758979 is a potent and highly selective oral H 4 R antagonist. Objective We sought to evaluate the safety and efficacy of the H 4 R‐antagonist JNJ ‐39758979 in adult patients with uncontrolled asthma. Methods One hundred and fifteen eligible patients were randomly assigned to JNJ ‐39758979 300?mg or placebo once daily for 12?weeks in this phase 2a, double‐blind, multicenter, placebo‐controlled study. Primary efficacy was assessed via week‐12 change from baseline in pre‐bronchodilator forced expiratory volume in 1?second ( FEV 1 ). Secondary efficacy assessments included patient‐reported outcome ( PRO ) asthma assessments (Asthma Daily Diary data [ AM and PM peak expiratory flow rate, number of puffs of albuterol/salbutamol, the presence of nocturnal awakenings and asthma symptom score]). Results The study did not meet the primary end‐point. However, nominally significant improvements in pre‐bronchodilator FEV 1 were observed with JNJ ‐39758979 versus placebo at week 12 in pre‐specified subgroups with elevated exhaled nitric oxide, sputum eosinophils or blood eosinophils at baseline. Nominally significant improvements across PRO assessments were consistently observed in the overall population, as well as in eosinophilic subgroups. Safety, such as adverse event rates, was comparable between JNJ ‐39758979 and placebo. No serious adverse events were reported. No clinically relevant changes in laboratory values were observed. Conclusions and Clinical Relevance The findings suggest potential benefit of H 4 R antagonists on lung function and asthma control in eosinophilic asthma patients and warrant further evaluation of this mechanism in asthma with eosinophilic inflammation. NCT 00946569.
机译：发明内容背景H 4 R拮抗剂在临床前哮喘模型的影响支持H 4 R在人类哮喘治疗中的拮抗剂的研究。 JNJ -39758979是一种有效且高度选择性的口服H 4 R拮抗剂。目的我们试图评估H 4 R-拮抗剂JNJ -39758979在成人患者中的不受控制哮喘的安全性和有效性。方法将一百十五名符号患者随机分配给JNJ -39758979 300？Mg或安慰剂每日一次，在这一相2A，双盲，多中心，安慰剂对照研究中。通过第12周的第12周评估初级疗效在1？第二（FEV 1）中从支气管扩张剂强制呼气量的基线进行评估。二次疗效评估包括患者报告的结果（Pro）哮喘评估（哮喘日日记数据[AM和PM峰值呼气流量，氨基甲酚/萨尔丁胺醇的数量，夜间唤醒的存在和哮喘症状评分]）。结果研究没有符合主要终点。然而，在预先指定的亚组中，在第12周观察到前支气管扩张剂FEV 1的标称显着改善，在预先指定的亚组中，在基线下升高的次氧化氮，痰嗜酸盐粒细胞或血液嗜酸性粒细胞。在整体人群中始终如一地观察到专业人群以及嗜酸性亚群的标称显着改善。诸如不良事件率的安全性，在JNJ -39758979和安慰剂之间是可比的。没有报道严重的不良事件。观察到实验室值的临床相关变化。结论和临床相关性研究结果表明H 4 R拮抗剂对嗜酸性哮喘患者肺功能和哮喘控制的潜在益处，并在嗜酸性炎症中进一步评价该机制的哮喘。 NCT 00946569。

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