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

November 10, 2024 updated by: Henan University of Traditional Chinese Medicine

Research on the Syndrome Characteristics of Chronic Airway Diseases (asthma, Chronic Obstructive Pulmonary Disease) Based on Intelligent Algorithm Fusion of Phenotype Omics

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

10545

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Zhiwan Wang Professor
  • Phone Number: 0371-66248624
  • Email: zhiwan_w@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory Phenotype of Chronic Airway Diseases
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%).
Each registered patient is measured only once at the time of registration.
The Traditional Chinese Medicine Syndromes of Athma
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.
Each registered patient is measured only once at the time of registration.
The Traditional Chinese Medicine Syndromes of COPD
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.
Each registered patient is measured only once at the time of registration.
General Demographic Data
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.
Each registered patient is measured only once at the time of registration.
Asthma Control Test (ACT)
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.
Each registered patient is measured only once at the time of registration.
COPD Assessment Test (CAT)
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.
Each registered patient is measured only once at the time of registration.
Clinical Symptoms and Signs Questionnaire
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.
Each registered patient is measured only once at the time of registration.
modified Medical Research Council (mMRC)
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.
Each registered patient is measured only once at the time of registration.
Forced Expiratory Volume in One Second (FEV1)
Time Frame: Each registered patient is measured only once at the time of registration.
FEV1 will be applied to assess pulmonary function.
Each registered patient is measured only once at the time of registration.
Forced Vital Capacity (FVC)
Time Frame: Each registered patient is measured only once at the time of registration.
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)
Time Frame: Each registered patient is measured only once at the time of registration.
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）
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.
Each registered patient is measured only once at the time of registration.
Sputum Characteristic Score
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.
Each registered patient is measured only once at the time of registration.
Sputum Viscosity Grading
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.
Each registered patient is measured only once at the time of registration.
mucin 5B（MUC5B）
Time Frame: Each registered patient is measured only once at the time of registration.
Using ELISA technology to detect MUC5B in induced sputum.
Each registered patient is measured only once at the time of registration.
mucin 5AC（MUC5AC）
Time Frame: Each registered patient is measured only once at the time of registration.
Using ELISA technology to detect MUC5AC in induced sputum.
Each registered patient is measured only once at the time of registration.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Henan University of Traditional Chinese Medicine

Collaborators

West China Hospital
Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science & Technology, China
Beijing Yikang Medical Technology Co., Ltd

Investigators

  • Study Chair: Suyu Li Professor, First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

July 31, 2028

Study Registration Dates

First Submitted

November 4, 2024

First Submitted That Met QC Criteria

November 10, 2024

First Posted (Estimated)

November 12, 2024

Study Record Updates

Last Update Posted (Estimated)

November 12, 2024

Last Update Submitted That Met QC Criteria

November 10, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Chronic Airway Disease

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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