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临床试验/NCT06840717
NCT06840717招募中不适用

Association Between Cytokines Gene Single Nucleotide Polymorphisms and Type 2 Inflammatory Asthma in Children

Guangzhou Institute of Respiratory Disease1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2024年1月30日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
300
试验地点
1
主要终点
type 2 inflammation indicators

研究概览

简要总结

To further understand the role of gene single nucleotide polymorphism (SNP) in the occurrence of type 2 inflammation-related asthma in children by analyzing the gene single nucleotide polymorphism (SNP), lung function and type 2 inflammation indicators of children diagnosed with asthma in outpatient and inpatient. To provide a theoretical basis for the study of personalized treatment and prevention strategies for asthma.

详细描述

Type of study:

This was a prospective, randomized case-control design.To investigate the role of genetic single nucleotide polymorphisms (SNPs) in children with type 2 asthma, and the effects of SNPs on type 2 inflammatory markers and pulmonary function indicators.

Methods:

Children with asthma who were treated at our pediatric respiratory specialty clinic and who met the criteria for type 2 inflammation were included in the case group (Type 2 inflammation was considered to be present if any of the following conditions were present: Fraction of exhaled nitric oxide(FeNO)≥20ppb;Blood eosinophilcount≥350/ul;Percentage of sputum eosinophils>3%; Asthma is caused by inhaled allergens.). The control group is healthy children who underwent physical examination. To compare the differences of single nucleotide polymorphisms (SNPs) between children with type 2 asthma and healthy children, and to explore the risk factors of type 2 asthma.

The differences of indicators between different genotypes were compared, including type 2 inflammation indicators (including Fraction of exhaled nitric oxide(FeNO)、Blood eosinophil count、Percentage of sputum eosinophils and Serum total immunoglobulin E) and pulmonary function indicators(Forced expiratory volume in one second(FEV1)、Forced vital capacity(FVC)、Ratio of forced expiratory volume in one second to forced vital capacity(FEV1/FVC) and Peak expiratory flow(PEF)).

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
3 Years 至 14 Years(Child)
性别
All
接受健康志愿者

入选标准

  • All children with asthma diagnosis accord with the GINA in 2023 edition;
  • Other diseases that could cause wheezing and cough were excluded, such as acute laryngitis, diphtheria, congenital airway abnormalities, and tracheal foreign bodies;
  • In front of the hospital 2 weeks without antibiotics, systemic hormone medication history;
  • There were no other complications, such as congenital heart disease, pneumonia, gastroesophageal reflux disease, muscle dysplasia, etc.

排除标准

  • Children who had taken immunosuppressants, antibiotics and other drugs for a long time before admission;
  • Children with primary immunodeficiency disease;
  • The children and their families failed to cooperate or refused the experimental observation.

结局指标

主要结局

type 2 inflammation indicators

时间窗: Outpatient visits for the first time

Fraction of exhaled nitric oxide(FeNO)、Blood eosinophil count、Percentage of sputum eosinophils and Serum total immunoglobulin E

pulmonary function indicators

时间窗: Outpatient visits for the first time

Forced expiratory volume in one second(FEV1)、Forced vital capacity(FVC)、Ratio of forced expiratory volume in one second to forced vital capacity(FEV1/FVC) and Peak expiratory flow(PEF)

single nucleotide polymorphism

时间窗: Outpatient visits for the first time

Differences in SNPs of genes detected in children's blood samples

次要结局

未报告次要终点

研究者

发起方
Guangzhou Institute of Respiratory Disease
申办方类型
Other
责任方
Principal Investigator
主要研究者

LI-HONG SUN

Professor

Guangzhou Institute of Respiratory Disease

研究点 (1)

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