Abstract: Background　The clinical control of severe asthma is poor and treatment methods are lacking，therefore more relevant clinical studies are urgently needed；the clinical trial registration can lay the foundation for clinical prevention，but the current situation of severe asthma is not clear and can not provide a new perspective for clinical trials.Objective　To study the registration characteristics of clinical trials of severe asthma based on the data of WHO international clinical trial registration platform（ICTRP）.Methods　The WHO ICTRP database was searched by computer，and the data of clinical trials with registration time from the establishment of the database to 2019-12-15 were collected.Two researchers independently screened the trial，extracted data，and then performed a descriptive analysis of the included trials.Results　A total of 235 clinical trials related to severe asthma were retrieved.The number of clinical trial registrations has been increasing year by year since the establishment of the database，and there has been a downward trend in the past 4 years.The trial application countries are unevenly distributed，the countries with high prevalence of severe asthma have few applications.Most trials in the registries come from their own country.The main sources of funds are units and enterprises.The main types of diseases in the study were severe asthma （89.36%），and the ages involved were mainly adults （90.64%）.The main type of trial was intervention （65.96%）.In the intervention trial，random trials accounted for 67.10%，and only 9 trials described their random methods；in the observational study，38.75% of the trials were the cohort study，44.26% of the trials did not indicate the blind method，and most of the other trials were double-blind （25.53%）.The mainly staging of the trial was N/A（32.77%） and phase III trial （20.00%）.The main intervention was drug intervention （77.42%）.The main outcomes were lung function，aggravation of asthma and evaluation of the life quality.Conclusion　The clinical trials of severe asthma have shown a downward trend in recent years，and the country of application for trials is unevenly distributed..The main research diseases are severe asthma，the research types are mainly interventional，and the intervention measures are mostly western medicine.

Key words: Asthma, Clinical trial, WHO international clinical trials registry platform, Research status

摘要： 背景　重症哮喘临床控制较差，且欠缺有效的治疗方法，故亟需更多相关临床研究；临床注册试验可为临床防治工作奠定基础，而目前重症哮喘临床注册现状尚不清楚，尚不能为临床试验提供新视角。目的　基于WHO国际临床试验注册平台（ICTRP）数据，了解重症哮喘临床试验注册特点。方法　计算机检索WHO ICTRP数据库，搜集建库起至2019-12-15注册的重症哮喘相关临床试验资料。由2名研究者独立筛选文献、提取资料后，对纳入试验进行描述性分析。结果　共检索到重症哮喘相关临床试验235个，临床试验注册数量自建库起逐年上升，近4年有下降趋势。试验申请国家分布不均，重症哮喘患病率较高国家试验申请极少。各注册中心试验大多来自本国家。资金主要来源于单位和企业。研究病种以重症哮喘为主（89.36%），涉及年龄以成人为主（90.64%）。试验类型以干预性为主（65.96%），干预性试验中随机试验占67.10%，仅9个试验描述其采用的随机方法；观察性研究中以队列研究居多（38.75%）；44.26%的试验未注明盲法情况，其余试验双盲占据较多（25.53%）；试验分期以N/A（32.77%）、Ⅲ期试验（20.00%）最多。干预措施以药物干预为主（77.42%）。结局指标以肺功能、哮喘加重情况、生存质量评价为主。结论　重症哮喘临床试验近几年呈下降趋势，试验申请国家分布不均，研究病种以重症哮喘为主，研究类型以干预性为主，干预措施多为西药干预。

关键词: 哮喘, 临床试验, WHO国际临床试验注册平台, 研究现状