• 主题
高级搜索  >
历史搜索 清空历史
首页> 外文期刊>Pulmonary therapy. >New Anti-Chemokine Oral Drug XC8 in the Treatment of Asthma Patients with Poor Response to Corticosteroids: Results of a Phase 2A Randomized Controlled Clinical Trial
【24h】

New Anti-Chemokine Oral Drug XC8 in the Treatment of Asthma Patients with Poor Response to Corticosteroids: Results of a Phase 2A Randomized Controlled Clinical Trial

机译：新的抗趋化因子口服药物XC8治疗哮喘患者对皮质类固醇的反应不良：2A相随机对照临床试验的结果

获取原文
           
页面导航
  • 摘要
  • 著录项
  • 相似文献
  • 相关主题

摘要

IntroductionA significant number of patients with moderate asthma remain symptomatic despite treatment with inhaled corticosteroids (ICS). These patients do not yet meet the criteria for oral corticosteroids (OCS) and monoclonal antibodies. The new anti-chemokine oral drug XC8 could represent an alternative treatment option for these patients. The objective of this trial was to evaluate the effect of different doses of the XC8 in patients with partly controlled asthma in a phase 2a clinical trial.MethodsA double-blind, parallel-group, randomized, multicenter, phase 2a trial was conducted at 12 sites in Russia. Patients with asthma were randomized into four groups ( n =?30 each) to receive XC8 at 2?mg, 10?mg, 100?mg or placebo once-daily for 12?weeks in addition to low-dose ICS with or without LABA. Efficacy and safety parameters were evaluated at weeks 0, 2, 6, and 12.ResultsNo statistically significant difference between the treatment arms in the number of patients with adverse events was observed. The primary endpoint, improvement of forced expiratory volume in 1?s (FEVsub1/sub) % predicted over 12?weeks compared to placebo, was not statistically significant. The treatment of patients with XC8?(100?mg) resulted in statistically and clinically significant improvements in FEVsub1/sub compared to baseline (7.40% predicted, p ?0.001). Patients with elevated peripheral blood eosinophil count (PBEC,??300 cells/μl) or serum interferon-γ (IFN-γ) level (?100?pg/mL) treated with XC8 (100?mg) achieved a statistically significant improvement in FEVsub1/sub (11.33% predicted or 8.69% predicted, respectively, p ?0.05) as compared to the baseline versus the placebo. The strongest effect was observed in patients with both high PBEC and IFN-γ level. Pharmacodynamic engagement was demonstrated through the reduction of serum levels of C–C motif ligand 2 (CCL2) and C–X–C motif chemokine 10 (CXCL10). Treatment with XC8?(100?mg) alleviated resistance to maintenance ICS therapy in patients with elevated IFN-γ level.ConclusionsGiven the high safety, oral route of administration, and efficacy, XC8 may provide a promising treatment option for patients with mild-to-moderate asthma.Trial Registration795–30/12/2015 (Ministry of Health Russian Federation), NCT03450434 (ClinicalTrials.gov).
机译：尽管用吸入的皮质类固醇（ICS）治疗，但仍有大量患有中度哮喘的患者仍然存在症状。这些患者尚未符合口腔皮质类固醇（OCS）和单克隆抗体的标准。新的抗趋化因子口腔药物XC8可以代表这些患者的替代治疗选择。该试验的目的是评估不同剂量的XC8在临床试验中部分控制的哮喘患者的效果。在12个位点进行多级，平行组，随机，多中心，相2a试验在俄国。哮喘患者被随机分为四组（n =Δ30），以在2℃下接收XC8，10μm，100μmg或安慰剂，除了有或没有LABA的低剂量IC 。在数周0,2,6和12.观察到不良事件的患者数量之间的疗效和安全参数评估了疗效和安全参数。初级终点，改善强制呼气量在1？S（FEV 1 ）％超过12？周数与安慰剂相比，没有统计学意义。 XC8患者的治疗（100？MG）导致FEV 1 与基线相比的统计学和临床​​显着改善（预测，P <0.001）。患有肝脏升高的患者（PBEC，α> 300个细胞/μl）或患有XC8（100μm1）处理的血清干扰素-γ（IFN-γ）水平（>α100γ）水平（> 100·pg / ml）达到统计学意义与基线与安慰剂相比，FEV 1 （预测的11.33％或8.69％）的改进分别预测，P <0.05）。在高pBEC和IFN-γ水平患者中观察到最强烈的效果。通过减少血清水平的C-C基序配体2（CCl 2）和C-X-C型趋化因子10（CXCL10）来证明药效学啮合。用XC8治疗（100？Mg）缓解IFN-γ水平升高的患者对维持ICS治疗的抵抗力。控制高安全性，口腔给药途径，XC8可为轻度至患者提供有希望的治疗选择 - 提供哮喘哮喘.TRIAL ENGINEDY795-30 / 12/2015（卫生部俄罗斯联邦），NCT03450434（Clinicaltrials.gov）。

著录项

相似文献

  • 外文文献
  • 中文文献
  • 专利
获取原文

客服邮箱：kefu@zhangqiaokeyan.com

京公网安备：11010802029741号 ICP备案号：京ICP备15016152号-6 六维联合信息科技 (北京) 有限公司©版权所有

  • 客服微信

  • 服务号