Participants fill out the questionnaire
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NCT Number: NCT06685315
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.
Trial opening soon.
Get Notified12 year–80 year
All sexes
Observational
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Participants fill out the questionnaire
Time frame: Each registered patient is measured only once at the time of registration.
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%).
Time frame: Each registered patient is measured only once at the time of registration.
Using the "Diagnostic Criteria for Traditional Chinese Medicine Syndromes of Bronchial Asthma (2016 Edition)" to assess the TCM syndromes of asthma.
Time frame: Each registered patient is measured only once at the time of registration.
Using the "Diagnostic Criteria for Traditional Chinese Medicine Syndromes of Chronic Obstructive Pulmonary Disease (2011 Edition)" to assess the TCM syndromes of COPD.
Time frame: Each registered patient is measured only once at the time of registration.
General demographic data, including name, age(years), sex(male / female), BMI(kg/m2), occupation, smoking history (years)and drinking history(years), will be recorded.
Time frame: Each registered patient is measured only once at the time of registration.
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.
Time frame: Each registered patient is measured only once at the time of registration.
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.
Time frame: Each registered patient is measured only once at the time of registration.
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.
Time frame: Each registered patient is measured only once at the time of registration.
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.
Time frame: Each registered patient is measured only once at the time of registration.
FEV1 will be applied to assess pulmonary function.
Time frame: Each registered patient is measured only once at the time of registration.
FVC will be applied to assess pulmonary function
Time frame: Each registered patient is measured only once at the time of registration.
DLCO will be applied to assess pulmonary function.
Time frame: Each registered patient is measured only once at the time of registration.
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.
Time frame: Each registered patient is measured only once at the time of registration.
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.
Time frame: Each registered patient is measured only once at the time of registration.
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.
Time frame: Each registered patient is measured only once at the time of registration.
Using ELISA technology to detect MUC5B in induced sputum.
Time frame: Each registered patient is measured only once at the time of registration.
Using ELISA technology to detect MUC5AC in induced sputum.
Contact information is provided by the study sponsor or research team.
Henan University of Traditional Chinese Medicine
Other
Research on the Syndrome Characteristics of Chronic Airway Diseases (asthma, Chronic Obstructive Pulmonary Disease) Based on Intelligent Algorithm Fusion of Phenotype Omics
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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