Research on the Characteristics of Chronic Airway Diseases (asthma, COPD)

NCT06685315 | Not Yet Recruiting DMC

• 1 other identifier: Chronic Airway Disease
• Study Type: observational
• Target: 10,545
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Asthma Bronchiale; Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Asthma; Chronic Obstructive Pulmonary Disease; Phenomics; Intelligent algorithms; Epidemiological investigation

Outcome Measures

Primary Outcomes (16)

• 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.

  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.

Interventions

Participants fill out the questionnaire OTHER

Participants fill out the questionnaire

Eligibility Criteria

• Age: 12 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• West China Hospital: collaborator
• Beijing Yikang Medical Technology Co., Ltd: collaborator
• Tongji Hospital: collaborator

Biospecimen

Retention: SAMPLES WITHOUT DNA

Collect peripheral blood, bronchoalveolar lavage fluid, urine, sputum, and feces to analyze biomarkers for different syndromes of asthma and chronic obstructive pulmonary disease

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Asthma

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bronchial Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Suyu Li Professor

  First Affiliated Hospital of Henan University of Traditional Chinese Medicine

  STUDY CHAIR

Central Study Contacts

Zhiwan Wang Professor

CONTACT

0371-66248624; zhiwan_w@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 4, 2024
• First Posted: November 12, 2024
• Study Start: December 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): July 31, 2028
• Last Updated: November 12, 2024

Record last verified: 2024-11