Health TrialsbyHealthPanel

The Role of Biomarkers in the Occurrence and Development of Asthma

ConditionAsthma in Children
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age4-12
SponsorChildren's Hospital of Chongqing Medical University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial population

Children with typical asthma symptoms, such as cough, wheezing, chest tightness, dyspnea and abnormal lung function tests, were diagnosed with asthma by a respiratory doctor

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • The level of biomarkers in Peripheral blood

    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.

Treatment groups

2 Participants
are divided into 2 treatment groups
Group A: Asthma group1 intervention
Group B: Control group1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
2years

Secondary outcomes

1

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.

Time frame
2 years
2

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.

Time frame
2 years
3

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.

Time frame
2 years
4

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.

Time frame
2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Children's Hospital of Chongqing Medical University

Lead sponsor

Source ClinicalTrials.gov
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