NCT06840717

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.

Trial Health

57
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 30, 2024

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

February 21, 2025

Status Verified

February 1, 2025

Enrollment Period

1.9 years

First QC Date

October 3, 2024

Last Update Submit

February 18, 2025

Conditions

Keywords

cytokinesSingle nucleotide polymorphismtype 2 inflammationashtmaSusceptibility

Outcome Measures

Primary Outcomes (3)

  • type 2 inflammation indicators

    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

    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

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

    Outpatient visits for the first time

Study Arms (2)

Case group

Diagnosis of asthma children

Control group

Physical health of children

Eligibility Criteria

Age3 Years - 14 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsThere was no significant difference in the ratio of male to female between the case and control groups
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Children with asthma, aged 3-14 years, attending our hospital.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangzhou institute of respiratory disease

Guangzhou, Guangdong, 510120, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

For children enrolled in this study, 2ml EDTA anticoagulated whole blood was retained

MeSH Terms

Conditions

Genetic Diseases, InbornInflammationDisease Susceptibility

Condition Hierarchy (Ancestors)

Congenital, Hereditary, and Neonatal Diseases and AbnormalitiesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 3, 2024

First Posted

February 21, 2025

Study Start

January 30, 2024

Primary Completion

December 30, 2025

Study Completion

December 30, 2025

Last Updated

February 21, 2025

Record last verified: 2025-02

Locations