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NCT Number: NCT05768399

The Role of Biomarkers in the Occurrence and Development of Asthma

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.

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Key information

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shaoqing Zhang

Chongqing, Chongqing Municipality, 400000, China

Location status: Recruiting

Location contact

Yuehan Li, PHD student

CONTACT

[email protected]

15397618298

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: pulmonary function, blood test, specific IgE

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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. 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.

  3. 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.

  4. 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.

  5. specific IgE

    Time frame: 2 years

    The correlation of blood specific IgE and the level of biomarkers in children with asthma

  6. Peripheral blood eosinophil count

    Time frame: 2 years

    The correlation of peripheral blood eosinophil count and the level of biomarkers in children with asthma

  7. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Ding Fengxia, PhD

CONTACT

[email protected]

86-15178712548 ext. 86-18090164586

Li Yuehan, PhD student

CONTACT

[email protected]

86-15397618298

Sponsors and collaborators

Lead sponsor

Children's Hospital of Chongqing Medical University

Other

Registry information

Important dates

Study start
2023
Primary completion
2028
Study completion
2029
First posted
Mar 14, 2023
Registry last updated
Jul 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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