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NCT Number: NCT06840717

Association Between Genetic Polymorphisms and Type 2 Asthma in Children

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.

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Key information

Age range

3 year–14 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Lihong Sun, master

CONTACT

[email protected]

+86-13719240285

About this study

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)).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. type 2 inflammation indicators

    Time frame: Outpatient visits for the first time

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

  2. pulmonary function indicators

    Time frame: 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)

  3. single nucleotide polymorphism

    Time frame: Outpatient visits for the first time

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lanying Cheng

CONTACT

[email protected]

15918742726

Lihong Sun, M.D.

CONTACT

[email protected]

13719240285

Sponsors and collaborators

Lead sponsor

Guangzhou Institute of Respiratory Disease

Other

Registry information

Official study title

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

Acronym: SNP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 21, 2025
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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