Asthma BronchialeNCT06685315
Research on the Characteristics of Chronic Airway Diseases (asthma, COPD)
An observational study of Asthma Bronchiale and Chronic Obstructive Pulmonary Disease (COPD), run by Henan University of Traditional Chinese Medicine.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 to 80 years
- Conditions the study is for
- Asthma Bronchiale, Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Participants fill out the questionnaire
- How many people
- 10,545 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to 31 Jul 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Being tested
- Participants fill out the questionnaire
- Keywords
- Asthma, Chronic Obstructive Pulmonary Disease, Phenomics, Intelligent algorithms, Epidemiological investigation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants fill out the questionnaireOther
Participants fill out the questionnaire
What is being measured
The primary outcome is the main question the study is designed to answer.
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%).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Each registered patient is measured only once at the time of registration.
Forced Vital Capacity (FVC)
FVC will be applied to assess pulmonary function
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Each registered patient is measured only once at the time of registration.
mucin 5B（MUC5B）
Using ELISA technology to detect MUC5B in induced sputum.
Measured: Each registered patient is measured only once at the time of registration.
mucin 5AC（MUC5AC）
Using ELISA technology to detect MUC5AC in induced sputum.
Measured: Each registered patient is measured only once at the time of registration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2024 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma BronchialeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 10,545 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, Beijing Yikang Medical Technology Co., Ltd, Tongji Hospital
- Responsible party
- Sponsor
- Investigators
- Suyu Li Professor, Study chair, First Affiliated Hospital of Henan University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06685315
- Sponsor's protocol ID
- Chronic Airway Disease
- Status last verified
- Nov 2024
- First submitted
- 4 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research on the Syndrome Characteristics of Chronic Airway Diseases (asthma, Chronic Obstructive Pulmonary Disease) Based on Intelligent Algorithm Fusion of Phenotype Omics
- ClinicalTrials.gov ID
- NCT06685315
- Acronym / sponsor ID
- Chronic Airway Disease
- Keywords
- Asthma, Chronic Obstructive Pulmonary Disease, Phenomics, Intelligent algorithms, Epidemiological investigation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 10,545 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- West China Hospital, Beijing Yikang Medical Technology Co., Ltd, Tongji Hospital
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 12 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Participants fill out the questionnaireParticipants fill out the questionnaire | Other | – |
Primary outcome
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%).
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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Suyu Li Professor study chair
First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Bronchiale and Chronic Obstructive Pulmonary Disease (COPD), run by Henan University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhiwan Wang Professor (0371-66248624, zhiwan_w@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Phenotype of Chronic Airway Diseases (time frame: Each registered patient is measured only once at the time of registration.). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.