The Role of Biomarkers in the Occurrence and Development of Asthma

Asthma in Children Clinical Trial

Official title:

The Role of Biomarkers in the Occurrence and Development of Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05768399
• Other study ID #: File No.2023.225
• Status: Recruiting
• Start date: July 4, 2023
• Est. completion date: December 31, 2029

Study information

• Verified date: July 2023
• Source: Children's Hospital of Chongqing Medical University
• Contact: Ding Fengxia, PhD
• Phone: 86-15178712548
• Email: dingfengxia305[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: December 31, 2029
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Diagnostic Test:
• The 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.

Locations

Country	Name	City	State
China	Shaoqing Zhang	Chongqing	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital of Chongqing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The level of biomarkers	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 using RT-qPCR? ELISA? Flow cytometry and other methods.	2years
Secondary	Pulmonary function(FEV1%)	The 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.	2 years
Secondary	Pulmonary function(FVC%)	The 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.	2 years
Secondary	Pulmonary function(FEV1/FVC)	The 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.	2 years
Secondary	Pulmonary function(PEF%)	The 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.	2 years
Secondary	specific IgE	The correlation of blood specific IgE and the level of biomarkers in children with asthma	2 years
Secondary	Peripheral blood eosinophil count	The correlation of peripheral blood eosinophil count and the level of biomarkers in children with asthma	2 years
Secondary	Childhood Asthma Control Test (C-ACT)	The 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.	2 years