Clinical trial NCT06685315: Research on the Characteristics of Chronic Airway Diseases (asthma, COPD)
Official title: Research on the Syndrome Characteristics of Chronic Airway Diseases (asthma, Chronic Obstructive Pulmonary Disease) Based on Intelligent Algorithm Fusion of Phenotype Omics
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Asthma Bronchiale
Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Asthma
Chronic Obstructive Pulmonary Disease
Phenomics
Intelligent algorithms
Epidemiological investigation
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: West China Hospital
name: Beijing Yikang Medical Technology Co., Ltd
name: Tongji Hospital
First posted: 2024-11-12
Enrollment: 10545
Sex: ALL
Minimum age (years): 12
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 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

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Meets the diagnostic criteria for asthma or COPD.
* Age of athma range from 12 years to 80 years.Age of COPD range from 18 years to 80 years.
* The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.

Exclusion Criteria:

* Patients with respiratory diseases such as interstitial lung disease, lung malignant tumor, lung infectious diseases, pneumothorax, pleural effusion, etc., which affect the syndrome differentiation.
* Patients with combining severe cardiovascular and cerebrovascular diseases, severe liver and kidney diseases, severe hematological malignancies, etc., affecting syndrome differentiation.
* Patients with delirium, dementia, various mental illnesses.

Primary outcomes:
measure: Inflammatory Phenotype of Chronic Airway Diseases
timeFrame: Each registered patient is measured only once at the time of registration.
measure: The Traditional Chinese Medicine Syndromes of Athma
timeFrame: Each registered patient is measured only once at the time of registration.
measure: The Traditional Chinese Medicine Syndromes of COPD
timeFrame: Each registered patient is measured only once at the time of registration.
measure: General Demographic Data
timeFrame: Each registered patient is measured only once at the time of registration.
measure: Asthma Control Test (ACT)
timeFrame: Each registered patient is measured only once at the time of registration.
measure: COPD Assessment Test (CAT)
timeFrame: Each registered patient is measured only once at the time of registration.
measure: Clinical Symptoms and Signs Questionnaire
timeFrame: Each registered patient is measured only once at the time of registration.
measure: modified Medical Research Council (mMRC)
timeFrame: Each registered patient is measured only once at the time of registration.
measure: Forced Expiratory Volume in One Second (FEV1)
timeFrame: Each registered patient is measured only once at the time of registration.
measure: Forced Vital Capacity (FVC)
timeFrame: Each registered patient is measured only once at the time of registration.
measure: Diffusing capacity of the lungs for carbon monoxide (DLCO)
timeFrame: Each registered patient is measured only once at the time of registration.
measure: Cough and Sputum Assessment Questionnaire （CASA-Q）
timeFrame: Each registered patient is measured only once at the time of registration.
measure: Sputum Characteristic Score
timeFrame: Each registered patient is measured only once at the time of registration.
measure: Sputum Viscosity Grading
timeFrame: Each registered patient is measured only once at the time of registration.
measure: mucin 5B（MUC5B）
timeFrame: Each registered patient is measured only once at the time of registration.
measure: mucin 5AC（MUC5AC）
timeFrame: Each registered patient is measured only once at the time of registration.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital of Henan University of Traditional Chinese Medicine
name: Suyu Li Professor
role: STUDY_CHAIR
References: