- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06840717
Association Between Genetic Polymorphisms and Type 2 Asthma in Children (SNP)
Association Between Cytokines Gene Single Nucleotide Polymorphisms and Type 2 Inflammatory Asthma in Children
Study Overview
Status
Conditions
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)).
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Lihong Sun, M.D.
- Phone Number: 13719240285
- Email: sunlihong9797@126.com
Study Contact Backup
- Name: Lanying Cheng
- Phone Number: 15918742726
- Email: chenglanyingmed@163.com
Study Locations
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Guangdong
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Guangzhou, Guangdong, China, 510120
- Recruiting
- Guangzhou Institute of Respiratory Disease
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Contact:
- Lihong Sun, master
- Phone Number: +86-13719240285
- Email: sunlihong9797@126.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Case group
Diagnosis of asthma children
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Control group
Physical health of children
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
Outpatient visits for the first time
|
|
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)
|
Outpatient visits for the first time
|
|
single nucleotide polymorphism
Time Frame: Outpatient visits for the first time
|
Differences in SNPs of genes detected in children's blood samples
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Outpatient visits for the first time
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- GuangzhouIRD-CLY
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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