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| Name | Class |
|---|---|
| West China Hospital | OTHER |
| Beijing Yikang Medical Technology Co., Ltd | UNKNOWN |
| Tongji Hospital | OTHER |
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This study will to investigate the correlation between the characteristics of the population with chronic airway diseases (asthma, chronic obstructive pulmonary disease) and syndromes, in order to reveal the disease and syndrome features of the population; Secondly, screening and identifying biomarkers for asthma and chronic obstructive pulmonary disease to provide a basis for precise prevention and treatment of the disease.
Chronic airway diseases are a group of non-specific chronic airway inflammatory diseases, with a heavy disease burden and serious harm to public health. Bronchial asthma and chronic obstructive pulmonary disease are the most common and representative chronic airway diseases, with significant clinical heterogeneity and unclear disease syndrome relationships. Clarifying the characteristics of asthma and chronic obstructive pulmonary disease populations, disease features, syndrome features, and their interrelationships is an important prerequisite for achieving personalized treatment and improving efficacy. Therefore, this study adopted a stratified random sampling clinical epidemiological survey method, selecting more than 10000 asthma and chronic obstructive pulmonary disease patients nationwide, and applying an optimized respiratory disease intelligent clinical research platform to collect patient population data (age, respiratory disease history, etc.), disease information (staging, grading, typing), and syndrome information (empirical, deficiency, and mixed syndrome). Using intelligent algorithms such as high-dimensional Bayesian optimization MCC-BO, T-distribution random nearest neighbor embedding, multidimensional correlation analysis, etc. to analyze the correlation between population characteristics and diseases and syndromes; Elucidate the correlation points between different stages, grades, types, and syndromes of asthma and chronic obstructive pulmonary disease. Using phenomics and adaptive multi omics global similarity fusion method to identify their biomarkers, further revealing the disease characteristics of asthma and chronic obstructive pulmonary disease populations, and guiding the precise treatment of traditional Chinese and Western medicine.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Participants fill out the questionnaire | Other | Participants fill out the questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammatory Phenotype of Chronic Airway Diseases | The inflammation phenotype will be determined by measuring the different proportions of eosinophils, neutrophils and mast cells in induced sputum and peripheral blood.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 registered patient is measured only once at the time of registration. |
| The Traditional Chinese Medicine Syndromes of Athma | Using the "Diagnostic Criteria for Traditional Chinese Medicine Syndromes of Bronchial Asthma (2016 Edition)" to assess the TCM syndromes of asthma. | Each registered patient is measured only once at the time of registration. |
| The Traditional Chinese Medicine Syndromes of COPD | Using the "Diagnostic Criteria for Traditional Chinese Medicine Syndromes of Chronic Obstructive Pulmonary Disease (2011 Edition)" to assess the TCM syndromes of COPD. | Each registered patient is measured only once at the time of registration. |
| 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 registered patient is measured only once at the time of registration. |
| Asthma Control Test (ACT) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Chronic airway disease is a group of non-specific chronic airway inflammatory diseases, among which bronchial asthma and chronic obstructive pulmonary disease are the most common and representative. There are approximately 45.7 million asthma patients aged 20 and above in China; Nearly 100 million patients with chronic obstructive pulmonary disease are over 40 years old. Traditional Chinese and Western medicine have certain advantages in preventing and treating chronic airway diseases, but there are still key issues that restrict the improvement of therapeutic effects: the complex characteristics of chronic airway diseases, unclear disease syndrome relationships, and clear disease syndrome characteristics provide a basis for precise prevention and treatment of diseases
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiwan Wang Professor | Contact | 0371-66248624 | zhiwan_w@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Suyu Li Professor | First Affiliated Hospital of Henan University of Traditional Chinese Medicine | Study Chair |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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Collect peripheral blood, bronchoalveolar lavage fluid, urine, sputum, and feces to analyze biomarkers for different syndromes of asthma and chronic obstructive pulmonary disease
| Each registered patient is measured only once at the time of registration. |
| COPD Assessment Test (CAT) | 0-40 scores. Scores for each questionnaire item were tallied based on the participant's responses, and if the total score was >10, the participant needed to be seen by a physician for further testing to determine if they had COPD. | Each registered patient is measured only once at the time of registration. |
| Clinical Symptoms and Signs Questionnaire | Assessment will be performed by clinical symptoms and signs questionnaire. The clinical symptoms to be evaluated in this study include cough, expectoration, chest tightness, shortness of breath, wheezing and cyanosis. A score of 0-3 will be given to every symptom or sign with a higher score indicating a worse conditoin. | Each registered patient is measured only once at the time of registration. |
| modified Medical Research Council (mMRC) | The modified Medical Research Council (mMRC) scale is a 5-point (0-4) scale based on the severity of dyspnoea. "0" means no dyspnea perception, "4" means severe dyspnea perception. | Each registered patient is measured only once at the time of registration. |
| Forced Expiratory Volume in One Second (FEV1) | FEV1 will be applied to assess pulmonary function. | Each registered patient is measured only once at the time of registration. |
| Forced Vital Capacity (FVC) | FVC will be applied to assess pulmonary function | Each registered patient is measured only once at the time of registration. |
| Diffusing capacity of the lungs for carbon monoxide (DLCO) | DLCO will be applied to assess pulmonary function. | Each registered patient is measured only once at the time of registration. |
| Cough and Sputum Assessment Questionnaire （CASA-Q） | Using the CASA-Q to assess the impact of cough and sputum on the quality of life of patients with chronic airway diseases.The questionnaire covers four domains: cough symptoms (3 items), impact of cough (8 items), sputum symptoms (3 items), and impact of sputum (6 items). Each item is scored based on frequency from "never" to "always" and intensity from "not at all" to "a lot/extremely". For each domain, the items are aggregated and rescaled to obtain a score from 0 to 100, with higher scores indicating less respiratory impairment. | Each registered patient is measured only once at the time of registration. |
| Sputum Characteristic Score | Using sputum characteristics scoring to assess the impact of airway mucus hypersecretion in patients with chronic airway diseases, which mainly includes the amount of sputum, the color of sputum, the viscosity of sputum, odor, composition of sputum, and the degree of sputum expectoration. A comprehensive scoring scale from 1 to 5 is used, where 1 indicates normal sputum characteristics, and 5 indicates severely abnormal sputum characteristics. | Each registered patient is measured only once at the time of registration. |
| Sputum Viscosity Grading | Using sputum viscosity grading to assess airway mucus hypersecretion in chronic airway diseases. Grade 0 - No sputum, Grade 1 - Thin sputum, Grade 2 - Moderately viscous sputum, Grade 3 - Highly viscous sputum. | Each registered patient is measured only once at the time of registration. |
| mucin 5B（MUC5B） | Using ELISA technology to detect MUC5B in induced sputum. | Each registered patient is measured only once at the time of registration. |
| mucin 5AC（MUC5AC） | Using ELISA technology to detect MUC5AC in induced sputum. | Each registered patient is measured only once at the time of registration. |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001982 | Bronchial Diseases |
| D012130 | Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |