Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma

Henan University of Traditional Chinese Medicine

Status: Unknown

Conditions: Bronchial Asthma

Study type: Observational

Funder types: Other

Identifiers

NCT04128111

TCM syndrome of Asthma

Details and patient eligibility

About

This study aims to determine the TCM syndrome pattern and the distribution of inflammation phenotype in different stages of bronchial asthma; to explore the correlation between TCM syndrome and inflammation phenotype. Secondly screening biomarkers that can be recognized by TCM syndromes and inflammatory phenotypes of bronchial asthma, and provide a basis for individualized diagnosis and treatment of diseases.

Full description

The clinical heterogeneity of bronchial asthma was strong.The TCM syndrome was complicated and mostly treated on stage, type, excess and deficiency.The phenotype was numerous and more classified from inflammation type, clinical classification, internal phenotype, etc.The flammatory phenotype was the more common type.The pathological basis of asthma was closely related to the infiltration of inflammatory mediators such as Airway eosinophil cells, so it was important to find the specific biomarker. The correlation between TCM syndrome, inflammatory phenotype and its biomarker wsa not clear. So we put forward theoretical hypothesis:There was of correlation between TCM syndrome and inflammatory phenotype of asthma.The biological target was contributes to the confirmation for TCM syndrome and inflammatory phenotype.The following research was planned to be carried out: relying on the registration system of National TCM Clinical Research Base to enroll in 900 cases patients in the acute and remission period of asthma and healthy physical examination crowd, filling in the patient's general demographic data, disease status, lung function, TCM syndrome and score and collecting the sputum, exhaled gas, urine, peripheral venous serum specimens and biomarker to be tested on the same day. Based on the clinical research database, confirming syndrome and in phenotype, clarifying the correlation between syndrome and phenotype and selecting identifiable biomarker by using correlation analysis, principal component analysis, multiple regression analysis, neural network analysis and other methods.The research provided evidence for the study of the essence of syndrome and phenotype and provided evidence for individualized diagnosis and treatment of diseases.

Enrollment: 900 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Patients with definite dignosis of bronchial asthma or healthy volunteer;
2. Ages range from 18 years to 80 years old;
3. Not anticipated in other clinical studies within 1 month before enrollment;
4. Signed informed consent.

Exclusion criteria

1. Acute asthma exacerbation patients with respiratory failure, mechanical ventilation;
2. Patients with unconsciousness, dementia, various mental disorders;
3. Complicated with hematological malignancies , heart failure(Acute myocardial infarction, cardiac function grade 3 or above), severe liver or kidney diseases;
4. Complicated with neuromuscular disorders affecting respiratory and motor function, unable to complete the six-minute walk test;
5. People who are participating in other clinical trials.

Trial design

900 participants in 3 patient groups

Acute Exacerbation

Description:

Exacerbations of asthma are episodes characterized by a progressive increase in symptoms of shortness of breath, cough, wheezing or chest tightness and progressive decrease in lung function, i.e. they represent a change from the patient's usual status that is sufficient to require a change in treatment.

Non-acute exacerbation

Description:

Non-acute exacerbation of asthma includes chronic remission and clinical delays.Clinical remission stage refers to an absence of wheezing, chest tightness, cough and other symptoms for more than 1 year.Chronic duration refers to that symptoms, such as wheezing, chest tightness, cough and so on, attack at different frequency and different degrees every week.

Healthy Volunteer

Description:

Health is not only the absence of disease or infirmity, but also a state of physical, mental, and social perfection.