The Role of Biomarkers in the Occurrence and Development of Asthma

July 5, 2023 updated by: Fengxia Ding, Children's Hospital of Chongqing Medical University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Chongqing
      • Chongqing, Chongqing, China, 400000
        • Recruiting
        • Shaoqing Zhang
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 12 years (Child)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study 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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Asthma group
Children with asthma diagnosed by a respiratory physician
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.
Other Names:
  • pulmonary function, blood test, specific IgE
Control group
Children without respiratory disease or inflammatory diseases
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.
Other Names:
  • pulmonary function, blood test, specific IgE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of biomarkers
Time Frame: 2years
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pulmonary function（FEV1%）
Time Frame: 2 years
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
Pulmonary function（FVC%）
Time Frame: 2 years
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
Pulmonary function（FEV1/FVC）
Time Frame: 2 years
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
Pulmonary function（PEF%）
Time Frame: 2 years
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
specific IgE
Time Frame: 2 years
The correlation of blood specific IgE and the level of biomarkers in children with asthma
2 years
Peripheral blood eosinophil count
Time Frame: 2 years
The correlation of peripheral blood eosinophil count and the level of biomarkers in children with asthma
2 years
Childhood Asthma Control Test (C-ACT)
Time Frame: 2 years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Chongqing Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 4, 2023

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

February 7, 2023

First Submitted That Met QC Criteria

March 13, 2023

First Posted (Actual)

March 14, 2023

Study Record Updates

Last Update Posted (Actual)

July 7, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • File No.2023.225

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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