关键词: 哮喘, 临床试验, WHO国际临床试验注册平台, 研究现状

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