Clinical trial NCT06840717: Association Between Genetic Polymorphisms and Type 2 Asthma in Children
Official title: Association Between Cytokines Gene Single Nucleotide Polymorphisms and Type 2 Inflammatory Asthma in Children
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Asthma in Children
Genetic Disease
Inflammation
Keywords: cytokines
Single nucleotide polymorphism
type 2 inflammation
ashtma
Susceptibility
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2025-02-21
Enrollment: 300
Sex: ALL
Minimum age (years): 3
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children with asthma, aged 3-14 years, attending our hospital.

Brief summary: 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)).

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: type 2 inflammation indicators
timeFrame: Outpatient visits for the first time
measure: pulmonary function indicators
timeFrame: Outpatient visits for the first time
measure: single nucleotide polymorphism
timeFrame: Outpatient visits for the first time
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou institute of respiratory disease
state: Guangdong
Study officials:
References: