Abstract
背景和目标Gefapixant先前已经在每日高剂量下表现出在治疗难治性慢性咳嗽的功效。当前的研究探索了使用剂量降低方法治疗慢性咳嗽的P2X3受体拮抗剂Gefapixant的功效和耐受性。
材料和方法两项随机,双盲,安慰剂对照,跨界,剂量降低研究招募了患有难治性慢性咳嗽的参与者。分配患者接受升剂剂量的吉法利剂量(研究1:50-200 mg,研究2:7.5–50 mg)或安慰剂16天,然后在冲洗后越过。主要的终点是使用基线和每次剂量第4天的24小时内科咳嗽监测仪评估的咳嗽频率。患者报告的结果包括咳嗽严重性的视觉模拟量表和咳嗽严重性日记。
Results在临床研究中,与安慰剂相比,Gefapixant剂量≥30毫克咳嗽频率最大改善(P <0.05);报告的咳嗽严重程度措施以类似剂量改善。味道障碍与剂量表现出不同的关系,显然以≥150mg的剂量最大。
结论P2X3 antagonism with gefapixant demonstrates anti-tussive efficacy and improved tolerability at lower doses than previously investigated. Studies of longer duration are warranted.
Abstract
耐火性慢性咳嗽的患者在咳嗽中与先前评估的咳嗽相比,咳嗽的咳嗽显着降低。http://bit.ly/2Rg3q2t
Footnotes
This article has supplementary material available fromwww.qdcxjkg.com
This study is registered atwww.clinicaltrials.gov具有标识符号NCT02349425and on the EU Clinical Trials Register (EudraCT Number: 2015-000474-35) Data availability: the data sharing policy of Merck Sharp and Dohme Corp. (a subsidiary of Merck and Co., Inc., Kenilworth, NJ, USA), including restrictions, is available athttp://engagezone.msd.com/ds_documentation.php。Requests for access to the clinical study data can be submitted through the EngageZone site or通过电子邮件至dataaccess@merck.com。
作者的贡献:史密斯j:概念、德西gn or planning of the study, analysis of data, interpretation of results, drafting of the manuscript, critical review and revision of the manuscript. M.M. Kitt: conception, design or planning of the study, analysis of data, interpretation of results, critical review and revision of the manuscript. P. Butera: conception, design or planning of the study, acquisition of data, critical review and revision of the manuscript. S.A. Smith: analysis of data, critical review and revision of the manuscript. Y. Li: analysis of data, interpretation of results, critical review and revision of the manuscript. Z.J. Xu: analysis of data, critical review and revision of the manuscript. K. Holt: analysis of data, critical review and revision of the manuscript. S. Sen: analysis of data, drafting of the manuscript. M.R. Sher: acquisition of data, interpretation of results, critical review and revision of the manuscript. A.P. Ford: conception, design or planning of the study, interpretation of results, drafting of the manuscript, critical review and revision of the manuscript.
Conflict of interest: J.A. Smith reports research grants and personal fees for consultancy and advisory board work from Merck Inc., during the conduct of the study; research grants and personal fees for consultancy and advisory board work from GlaxoSmithKline, research grants and personal fees for consultancy from NeRRe Pharmaceuticals, Menlo, Bayer and Axalbion, personal fees for consultancy from Boehringer Ingleheim, Genentech, Neomed, Chiesi, Bellus and AstraZeneca, non-financial support (equipment provision) from Vitalograph, research grants from Afferent, outside the submitted work; in addition, has a patent “A method for generating output data” licensed.
Conflict of interest: M.M. Kitt was an employee of Merck/Afferent, during the conduct of the study.
Conflict of interest: P. Butera was an employee of Afferent Pharmaceuticals, Inc., during the conduct of the study.
利益冲突:S.A. Smith在进行研究期间报告了传入药品的咨询咨询费用。
利益冲突:Y. Li在进行研究期间从Adserent/Merck and Co.,Inc.的统计工作中报告了个人费用。
利益冲突:Z.J XU无需透露。
Conflict of interest: K. Holt has nothing to disclose.
Conflict of interest: S. Sen has nothing to disclose.
利益冲突:M.R. Sher在进行研究期间报告了传入和默克的个人费用;并且是Bellus,Bayer,Nerre的顾问,并与Menlo和Nerre进行了临床研究。
利益冲突:A.P.福特在进行研究期间是默克/传入的雇员。
支持声明:这项研究得到了Actrerent Pharmaceuticals Inc.的资助,该公司由美国新泽西州Kenilworth的Merck Sharp and Dohme Corp.收购。J.A.史密斯是由惠康研究员奖曼彻斯特生物医学研究中心资助的,是NIHR高级研究员。本文的资金信息已存入CrossRef资助人注册表。
- Received2019年8月13日。
- 公认2019年12月19日。
- 版权所有©ERS 2020
个人
登录using your username and password
库用户
通过您的机构登录
Purchase access
CONTACT US
If you have any questions about the ERS publications website, please contactjournals@ersnet.org