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The Role of Biomarkers in the Occurrence and Development of Asthma

The Role of Biomarkers in the Occurrence and Development of Asthma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05768399
Enrollment
2
Registered
2023-03-14
Start date
2023-07-04
Completion date
2029-12-31
Last updated
2023-07-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma in Children

Keywords

asthma, children, biomarkers

Brief summary

To study the expression level of biomarkers such as GITRL in peripheral blood of children with asthma and analyze their correlation with the severity of asthma. To study the predictive value of biomarkers level for the occurrence and development of asthma. And to provide supplementary detection means and predictive indicators for the diagnosis of asthma and the severity of asthma.

Detailed description

Recruit 30 children with asthma and 30 healthy children based on the consent of the children and their parents or their guardian. Collect and record general information such as name, age, time of first diagnosis, allergens or triggers, daily dosage and frequency of asthma control drugs, home address and contact information. Collect 5 ml of blood sample for the detect of the biomarkers. Asthma severity was assessed using pulmonary function by spirometry and score of C-CAT. Finally study the correlation between the level of biomarkers and asthma severity and the role of biomarkers in the occurrence and development of asthma.

Interventions

DIAGNOSTIC_TESTThe level of biomarkers in Peripheral blood

All participants will be extracted 5ml peripheral blood into the anticoagulant tube by nurses and the peripheral blood will be detected for biomarkers of asthma. Children with asthma will take pulmonary function, blood test and specific IgE test etc. The lung function test will be performed by professional technicians and the results will be interpreted by specialists. The blood test and specific IgE test will be collected by specialist nurses and the results will be issued by professional inspectors. Children with asthma and their guardians will be asked for filling the questionnaire of Childhood Asthma Control Test (C-ACT). And then the doctor will check and calculate the scores after completion.

Sponsors

Children's Hospital of Chongqing Medical University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
4 Years to 12 Years
Healthy volunteers
Yes

Inclusion criteria

* In line with the diagnostic criteria in the Guidelines for the Diagnosis and Prevention of Bronchial Asthma in Children (2016 Edition) * Age: 4-12 years old for new diagnosis or recurrent episodes * Typical clinical manifestations and complete clinical data * Family members or guardians of children with informed research and signed consent * All healthy control subjects had no history of lung disease, allergic rhinitis or any other atopic disease

Exclusion criteria

* Suffering from other respiratory diseases (such as bronchiectasis, allergic rhinitis, respiratory failure, tuberculosis, obstructive airway disease) or other inflammatory diseases. * Abnormal development of congenital airway and lung tissue * History of immunosuppressant or glucocorticoid use in the first 4 weeks * Suffering from other endocrine system and immune system diseases * Incomplete clinical data or examinations.

Design outcomes

Primary

MeasureTime frameDescription
The level of biomarkers2yearsAll participants will be extracted 5ml peripheral blood into the anticoagulant tube by nurses and the peripheral blood will be detected for biomarkers of asthma using RT-qPCR、 ELISA、 Flow cytometry and other methods.

Secondary

MeasureTime frameDescription
Pulmonary function(FEV1%)2 yearsThe correlation of pulmonary function (FEV1) and the level of biomarkers in children with asthma.The lung function test will be performed by professional technicians and the results will be interpreted by specialists.
Pulmonary function(FVC%)2 yearsThe correlation of pulmonary function (FVC%) and the level of biomarkers in children with asthma.The lung function test will be performed by professional technicians and the results will be interpreted by specialists.
Pulmonary function(FEV1/FVC)2 yearsThe correlation of pulmonary function (FEV1/FVC) and the level of biomarkers in children with asthma.The lung function test will be performed by professional technicians and the results will be interpreted by specialists.
Pulmonary function(PEF%)2 yearsThe correlation of pulmonary function (PEF%) and the level of biomarkers in children with asthma.The lung function test will be performed by professional technicians and the results will be interpreted by specialists.
specific IgE2 yearsThe correlation of blood specific IgE and the level of biomarkers in children with asthma
Peripheral blood eosinophil count2 yearsThe correlation of peripheral blood eosinophil count and the level of biomarkers in children with asthma
Childhood Asthma Control Test (C-ACT)2 yearsThe correlation of the score of C-ACT and the level of biomarkers in children with asthma. Children with asthma and their guardians will be asked for filling the questionnaire of Childhood Asthma Control Test (C-ACT). And then the doctor will check and calculate the scores after completion.

Countries

China

Contacts

Primary ContactDing Fengxia, PhD
dingfengxia305@163.com86-15178712548
Backup ContactLi Yuehan, PhD student
1214987864@qq.com86-15397618298

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026