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临床试验/NCT06837584
NCT06837584尚未招募不适用

A Multicenter Observational Study on the Current Status of Control and Treatment of Outpatient Children With Asthma and the Types of Airway Inflammation

Beijing Children's Hospital0 个研究点目标入组 42,000 人开始时间: 2026年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
42,000
主要终点
Asthma control level

研究概览

简要总结

The aim of this study is to comprehensively understand the disease control and management status of children with asthma in China, as well as the types of airway inflammation. The findings of this survey will help improve the asthma control level in Chinese children, facilitate future patient education, and guide rational medication use. Moreover, it will provide important evidence for health decision-making departments to better allocate and utilize medical resources.

详细描述

Bronchial asthma (hereinafter referred to as asthma) is the most common chronic respiratory disease in children. It severely affects the physical and mental health of children and imposes a huge economic burden on families and society, consuming a large amount of medical and health resources. In recent years, the prevalence of asthma in children worldwide has generally continued to rise. Data from the Global Burden of Disease database in 2019 showed that the prevalence of asthma in children aged 0-9 years was 4.21%, in children aged 10-14 years was 4.10%, and in adolescents aged 15-19 years was 3.00%. In China, over the past 20 years, the prevalence of asthma in children has also shown an overall upward trend, increasing from 0.91% in 1990 to 1.54% in 2000, and then to 3.02% in 2010. Thanks to the continuous efforts of several generations of pediatricians, the level of standardized diagnosis and treatment of childhood asthma has significantly improved. However, the control of asthma in children still faces many challenges.

The purpose of this study is to comprehensively understand the disease control and management status of children with asthma in China, as well as the types of airway inflammation. The findings of this survey will help improve the asthma control level in Chinese children, facilitate future patient education, guide rational medication use, and provide important evidence for health decision-making departments to better allocate and utilize medical resources.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
2 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age between 2 and 18 years old
  • •Diagnosed with asthma for more than 3 months
  • •Had asthma symptoms or asthma treatment within the past 12 months.

排除标准

  • •With other respiratory diseases such as bronchiectasis, bronchiolitis, cystic fibrosis, and pneumonia
  • •Have participated in any interventional clinical studies related to asthma within the 3 months prior to enrollment in this study
  • •Parents, legal representatives, or guardians do not agree to participate in this study.

结局指标

主要结局

Asthma control level

时间窗: 3 months before and at the time of enrollment

The Asthma Control Test (ACT) will be employed for assessment, with the following interpretation criteria: a total score of 20-25 indicates well-controlled asthma, where symptoms are satisfactorily managed and the current treatment regimen should be continued; a score of 16-19 suggests poorly controlled asthma, indicating suboptimal symptom management that requires treatment adjustment or enhanced disease management; and a score of 5-15 reflects very poorly controlled asthma, with severe uncontrolled symptoms necessitating immediate medical attention and treatment modification.

The proportion of type 2 inflammation

时间窗: 3 months before and at the time of enrollment

Blood EOS and IgE were used to judge. The T2 inflammatory phenotypes were classified based on blood eosinophil count and total specific IgE levels: Only-atopy was defined as blood eosinophils \<300/μL with sum of all specific IgE ≥0.7 kU/L; Only-EOS as blood eosinophils ≥300/μL with sum of all specific IgE \<0.7 kU/L; T2-high as blood eosinophils ≥300/μL with sum of all specific IgE ≥0.7 kU/L; and T2-low as blood eosinophils \<300/μL with sum of all specific IgE \<0.7 kU/L.

次要结局

未报告次要终点

研究者

发起方
Beijing Children's Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Kunling Shen

Professior

Shenzhen Children's Hospital

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