The Role of Biomarkers in the Occurrence and Development of Asthma

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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 inspe

Первичные конечные точки

• The level of biomarkers [Срок оценки: 2years]

Вторичные конечные точки (7)

• Pulmonary function（FEV1%） [Срок оценки: 2 years]
• Pulmonary function（FVC%） [Срок оценки: 2 years]
• Pulmonary function（FEV1/FVC） [Срок оценки: 2 years]
• Pulmonary function（PEF%） [Срок оценки: 2 years]
• specific IgE [Срок оценки: 2 years]
• Peripheral blood eosinophil count [Срок оценки: 2 years]
• Childhood Asthma Control Test (C-ACT) [Срок оценки: 2 years]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

Китай · 1 центр

• Shaoqing Zhang — Чунцин

Идентификаторы

NCT: NCT05768399 · File No.2023.225

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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