Clinical trial NCT04128111: Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma
Official title: Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma: An Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchial Asthma
Keywords: Bronchial Asthma
TCM Syndrome
Inflammation Phenotype
Biomarker
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Henan Provincial People's Hospital
name: Guangdong Provincial Hospital of Traditional Chinese Medicine
First posted: 2019-10-16
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The diagnosis and staging of bronchial asthma refer to"Chinese Guideline for The Prevention and Management of Bronchial Asthma (2016 edition)"and "The Chinese experts'consensus on the evaluation and management of asthma exacerbation"by Chinese Society of Respiratory Diseases and China Asthma Alliance.

Reference Standard for Healthy Population The Concept of "Health" by the United Nations World Health Organization (WHO).The investigators will only enroll subjects in whom above diagnosis is firmly established.

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Inflammatory Phenotype
timeFrame: Each enrolled patient will be measured only once when enrollment.
Secondary outcomes:
measure: Biomarker
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: FeNO
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: Exhaled Breath Condensate（EBC）
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: Urine Specimen
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: Peripheral Venous Serum Specimens
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: TCM Syndrome
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: General demographic data
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: Disease Conditions
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: Asthma Control Test (ACT) Scores
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: ACQ-5 Scores
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: Lung function and diurnal variation rate of PEF
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: 6-minute walk test
timeFrame: Each enrolled patient will be measured only once when enrollment.
measure: Acute Exacerbations
timeFrame: Each enrolled patient will be measured only once when enrollment.
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Henan University of Chinese Medicine
name: Suyun Li, Professor
role: STUDY_DIRECTOR
References: