The Role of Biomarkers in the Occurrence and Development of Asthma

NCT ID: NCT05768399

Last Updated: 2023-07-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

2 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-04

Study Completion Date

2029-12-31

Brief Summary

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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

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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.

Conditions

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Asthma in Children

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Asthma group

Children with asthma diagnosed by a respiratory physician

The level of biomarkers in Peripheral blood

Intervention Type DIAGNOSTIC_TEST

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.

Control group

Children without respiratory disease or inflammatory diseases

The level of biomarkers in Peripheral blood

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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pulmonary function, blood test, specific IgE

Eligibility Criteria

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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.
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Children's Hospital of Chongqing Medical University

OTHER

Sponsor Role lead

Responsible Party

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Fengxia Ding

Reseacher

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Shaoqing Zhang

Chongqing, Chongqing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Ding Fengxia, PhD

Role: CONTACT

86-15178712548 ext. 86-18090164586

Li Yuehan, PhD student

Role: CONTACT

86-15397618298

Facility Contacts

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Yuehan Li, PHD student

Role: primary

15397618298

Other Identifiers

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File No.2023.225

Identifier Type: -

Identifier Source: org_study_id

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