Bronchial Asthma Clinical Trial
Official title:
Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma: An Observational Study
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.
Status | Recruiting |
Enrollment | 900 |
Est. completion date | December 2022 |
Est. primary completion date | July 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | The First Affiliated Hospital of Henan University of Traditional Chinese Medicine | Zhengzhou | Henan |
Lead Sponsor | Collaborator |
---|---|
Henan University of Traditional Chinese Medicine | Guangdong Provincial Hospital of Traditional Chinese Medicine, Henan Provincial Hospital |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Inflammatory Phenotype | 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%). | Each enrolled patient will be measured only once when enrollment. | |
Secondary | Biomarker | 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-a, Eotaxin-2, total IgE and specific IgE will be measured in peripheral venous serum samples will be measured. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | FeNO | Measurement of Exhaled Nitric Oxide by Swedish NIOX. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | Exhaled Breath Condensate(EBC) | EBC will be collected by EcoScreen, 8-isoprostaglandin, nitric oxide products and leukotrienes will be measured by ELISA. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | Urine Specimen | 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. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | Peripheral Venous Serum Specimens | 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 - a, eotaxin-2, etc. will be measured. All the procedures will be described according to the kit. Ming Shu operation. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | TCM Syndrome | According to the comprehensive analysis of four TCM diagnostic methods, the syndrome differentiation will be determined. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | General demographic data | General demographic data, including name, age(years), sex(male / female), BMI(kg/m2), occupation, smoking history (years)and drinking history(years), will be recorded. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | Disease Conditions | 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. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | Asthma Control Test (ACT) Scores | 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. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | ACQ-5 Scores | 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. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | Lung function and diurnal variation rate of PEF | 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. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | 6-minute walk test | 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. | Each enrolled patient will be measured only once when enrollment. | |
Secondary | Acute Exacerbations | The number, causes, treatment place, medications, costs and outcomes of acute exacerbations will be recorded. | Each enrolled patient will be measured only once when enrollment. |
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