Bronchial Asthma
Conditions
Keywords
Bronchial Asthma, TCM Syndrome, Inflammation Phenotype, Biomarker
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.
Interventions
None listed
Sponsors
Henan Provincial People's Hospital
Guangdong Provincial Hospital of Traditional Chinese Medicine
Henan University of Traditional Chinese Medicine
Study design
Observational model
OTHER
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammatory Phenotype | Each enrolled patient will be measured only once when enrollment. | The inflammation phenotype will be determined by measuring the different proportions of eosinophils, neutrophils and mast cells in induced sputum.The inflammatory phenotypes of asthma can be divided into eosinophil asthma(eosinophil \> 1.01%) ， neutrophil asthma(neutrophil \> 61%)， Oligocellular asthma (eosinophil \> 61%)and mixed cell asthma(eosinophil \> 1.01%, neutrophil \> 61%). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| FeNO | Each enrolled patient will be measured only once when enrollment. | Measurement of Exhaled Nitric Oxide by Swedish NIOX. |
| Exhaled Breath Condensate（EBC） | Each enrolled patient will be measured only once when enrollment. | EBC will be collected by EcoScreen, 8-isoprostaglandin, nitric oxide products and leukotrienes will be measured by ELISA. |
| Urine Specimen | Each enrolled patient will be measured only once when enrollment. | Urine will be taken from 2 to 3 mL in the morning and stored at - 70°C on ice. The level of LTE4 will be determined by ELISA. |
| Peripheral Venous Serum Specimens | Each enrolled patient will be measured only once when enrollment. | In the morning, 10ml of elbow vein blood will be extracted on an empty stomach, centrifuged at 3000rpm for 5min, and serum will be separated and stored at - 70 ℃. Serum eosinophils, eosinophil cationic protein, periosteal protein, total IgE , specific IgE, cytokines IL-4, IL-5, IL-8, IL-13, IL-17, TNF - α, eotaxin-2, etc. will be measured. All the procedures will be described according to the kit. Ming Shu operation. |
| TCM Syndrome | Each enrolled patient will be measured only once when enrollment. | According to the comprehensive analysis of four TCM diagnostic methods, the syndrome differentiation will be determined. |
| General demographic data | Each enrolled patient will be measured only once when enrollment. | General demographic data, including name, age（years）, sex(male / female), BMI(kg/m2), occupation, smoking history (years)and drinking history(years), will be recorded. |
| Biomarker | Each enrolled patient will be measured only once when enrollment. | Indicators such as 8-isoprostaglandin, nitric oxide products and leukotrienes in exhaled breath condensate, exhaled nitric oxide, urine LTE4, and serum eosinophils, eosinophilic cationic protein, periosteal protein, IL-4, IL-5, IL-8, IL-13, IL-17, TNF-α, Eotaxin-2, total IgE and specific IgE will be measured in peripheral venous serum samples will be measured. |
| Asthma Control Test (ACT) Scores | Each enrolled patient will be measured only once when enrollment. | ACT includes five questions. Every question will be assessed using a 5-point scale with scores ranging from 5 to 25. The higher the score, the better the symptom control.25 is considered complete control level, 20 \ 24 is considered good control level, and \<20 is considered non-control level. |
| ACQ-5 Scores | Each enrolled patient will be measured only once when enrollment. | There are seven questions, with a score of 0-6 in every question.The final ACQ score consists of the average score of the seven questions.The higher the score, the worse the symptom control. A score of 0 \ 0.75 means ideal asthma control; 0.75 \ 1.5 is the gray area;\> 1.5 indicates poor control. |
| Lung function and diurnal variation rate of PEF | Each enrolled patient will be measured only once when enrollment. | Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), the percentage of FEV1 in the estimated value, and the diurnal variation rate of PEF will be measured. |
| 6-minute walk test | Each enrolled patient will be measured only once when enrollment. | 6-minute walking distance will be measured.Reference to American Thoracic Society Six-minute walking test will be conducted on all subjects in the published Six-minute Walking Guidelines, and the six-minute walking distance will be measured. |
| Acute Exacerbations | Each enrolled patient will be measured only once when enrollment. | The number, causes, treatment place, medications, costs and outcomes of acute exacerbations will be recorded. |
| Disease Conditions | Each enrolled patient will be measured only once when enrollment. | The course of disease, number of acute attack，having a cold, disease-related hospitalizatation past year and drug use situations including glucocorticoid and bronchial diastole. |
Countries
China
Contacts
Primary ContactMihang Wang, Professor
Outcome results
None listed