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Recruiting NCT06840717

Association Between Genetic Polymorphisms and Type 2 Asthma in Children

Observational Asthma in Children Genetic Disease Inflammation

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Asthma in Children, Genetic Disease, Inflammation. Basic parameters: 3 years — 14 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Detailed description

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)).

Primary outcome measures

  • type 2 inflammation indicators [Time frame: Outpatient visits for the first time]
  • pulmonary function indicators [Time frame: Outpatient visits for the first time]
  • single nucleotide polymorphism [Time frame: Outpatient visits for the first time]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Guangzhou institute of respiratory disease — Guangzhou

Identifiers

NCT: NCT06840717 · GuangzhouIRD-CLY

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗