Bronchial AsthmaNCT04128111
Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma
An observational study of Bronchial Asthma, run by Henan University of Traditional Chinese Medicine at 1 site in China.
Trial summary
This study aims to determine the TCM syndrome pattern and the distribution of inflammation phenotype in different stages of bronchial asthma; to explore the correlation between TCM syndrome and inflammation phenotype. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bronchial Asthma
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 7 Oct 2019to Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The diagnosis and staging of bronchial asthma refer to"Chinese Guideline for The Prevention and Management of Bronchial Asthma (2016 edition)"and "The Chinese experts'consensus on the evaluation and management of asthma exacerbation"by Chinese Society of Respiratory Diseases and China Asthma Alliance. Reference Standard for Healthy Population The Concept of "Health" by the United Nations World Health Organization (WHO).The investigators will only enroll subjects in whom above diagnosis is firmly established.
Who may be able to join
- Patients with definite dignosis of bronchial asthma or healthy volunteer;
- Ages range from 18 years to 80 years old;
- Not anticipated in other clinical studies within 1 month before enrollment;
- Signed informed consent.
Who cannot join
- Acute asthma exacerbation patients with respiratory failure, mechanical ventilation;
- Patients with unconsciousness, dementia, various mental disorders;
- Complicated with hematological malignancies , heart failure(Acute myocardial infarction, cardiac function grade 3 or above), severe liver or kidney diseases;
- Complicated with neuromuscular disorders affecting respiratory and motor function, unable to complete the six-minute walk test;
- People who are participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Zhengzhou, Henan, 450000
Minghang Wang, Professor, 86-371-66248624, wmh107hn@163.com
About this study
Official title: Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma: An Observational Study
This study aims to determine the TCM syndrome pattern and the distribution of inflammation phenotype in different stages of bronchial asthma; to explore the correlation between TCM syndrome and inflammation phenotype. Secondly screening biomarkers that can be recognized by TCM syndromes and inflammatory phenotypes of bronchial asthma, and provide a basis for individualized diagnosis and treatment of diseases.
Read the detailed description
The clinical heterogeneity of bronchial asthma was strong.The TCM syndrome was complicated and mostly treated on stage, type, excess and deficiency.The phenotype was numerous and more classified from inflammation type, clinical classification, internal phenotype, etc.The flammatory phenotype was the more common type.The pathological basis of asthma was closely related to the infiltration of inflammatory mediators such as Airway eosinophil cells, so it was important to find the specific biomarker. The correlation between TCM syndrome, inflammatory phenotype and its biomarker wsa not clear. So we put forward theoretical hypothesis:There was of correlation between TCM syndrome and inflammatory phenotype of asthma.The biological target was contributes to the confirmation for TCM syndrome and inflammatory phenotype.The following research was planned to be carried out: relying on the registration system of National TCM Clinical Research Base to enroll in 900 cases patients in the acute and remission period of asthma and healthy physical examination crowd, filling in the patient's general demographic data, disease status, lung function, TCM syndrome and score and collecting the sputum, exhaled gas, urine, peripheral venous serum specimens and biomarker to be tested on the same day. Based on the clinical research database, confirming syndrome and in phenotype, clarifying the correlation between syndrome and phenotype and selecting identifiable biomarker by using correlation analysis, principal component analysis, multiple regression analysis, neural network analysis and other methods.The research provided evidence for the study of the essence of syndrome and phenotype and provided evidence for individualized diagnosis and treatment of diseases.
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial Asthma, TCM Syndrome, Inflammation Phenotype, Biomarker
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acute Exacerbation | Exacerbations of asthma are episodes characterized by a progressive increase in symptoms of shortness of breath, cough, wheezing or chest tightness and progressive decrease in lung function, i.e. they represent a change from the patient's usual status that is sufficient to require a change in treatment. | |
| Non-acute exacerbation | Non-acute exacerbation of asthma includes chronic remission and clinical delays.Clinical remission stage refers to an absence of wheezing, chest tightness, cough and other symptoms for more than 1 year.Chronic duration refers to that symptoms, such as wheezing, chest tightness, cough and so on, attack at different frequency and different degrees every week. | |
| Healthy Volunteer | Health is not only the absence of disease or infirmity, but also a state of physical, mental, and social perfection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory Phenotype
The inflammation phenotype will be determined by measuring the different proportions of eosinophils, neutrophils and mast cells in induced sputum.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 enrolled patient will be measured only once when enrollment.
Secondary outcomes (13)
Biomarker
Indicators such as 8-isoprostaglandin, nitric oxide products and leukotrienes in exhaled breath condensate, exhaled nitric oxide, urine LTE4, and serum eosinophils, eosinophilic cationic protein, periosteal protein, IL-4, IL-5, IL-8, IL-13, IL-17, TNF-α, Eotaxin-2, total IgE and specific IgE will be measured in peripheral venous serum samples will be measured.
Measured: Each enrolled patient will be measured only once when enrollment.
FeNO
Measurement of Exhaled Nitric Oxide by Swedish NIOX.
Measured: Each enrolled patient will be measured only once when enrollment.
Exhaled Breath Condensate（EBC）
EBC will be collected by EcoScreen, 8-isoprostaglandin, nitric oxide products and leukotrienes will be measured by ELISA.
Measured: Each enrolled patient will be measured only once when enrollment.
Urine Specimen
Urine will be taken from 2 to 3 mL in the morning and stored at - 70°C on ice. The level of LTE4 will be determined by ELISA.
Measured: Each enrolled patient will be measured only once when enrollment.
Peripheral Venous Serum Specimens
In the morning, 10ml of elbow vein blood will be extracted on an empty stomach, centrifuged at 3000rpm for 5min, and serum will be separated and stored at - 70 ℃. Serum eosinophils, eosinophil cationic protein, periosteal protein, total IgE , specific IgE, cytokines IL-4, IL-5, IL-8, IL-13, IL-17, TNF - α, eotaxin-2, etc. will be measured. All the procedures will be described according to the kit. Ming Shu operation.
Measured: Each enrolled patient will be measured only once when enrollment.
TCM Syndrome
According to the comprehensive analysis of four TCM diagnostic methods, the syndrome differentiation will be determined.
Measured: Each enrolled patient will be measured only once when enrollment.
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 enrolled patient will be measured only once when enrollment.
Disease Conditions
The course of disease, number of acute attack，having a cold, disease-related hospitalizatation past year and drug use situations including glucocorticoid and bronchial diastole.
Measured: Each enrolled patient will be measured only once when enrollment.
Asthma Control Test (ACT) Scores
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 enrolled patient will be measured only once when enrollment.
ACQ-5 Scores
There are seven questions, with a score of 0-6 in every question.The final ACQ score consists of the average score of the seven questions.The higher the score, the worse the symptom control. A score of 0 ~ 0.75 means ideal asthma control; 0.75 ~ 1.5 is the "gray" area;> 1.5 indicates poor control.
Measured: Each enrolled patient will be measured only once when enrollment.
Lung function and diurnal variation rate of PEF
Forced vital capacity (FVC), forced expiratory volume in one second (FEV1), the percentage of FEV1 in the estimated value, and the diurnal variation rate of PEF will be measured.
Measured: Each enrolled patient will be measured only once when enrollment.
6-minute walk test
6-minute walking distance will be measured.Reference to American Thoracic Society Six-minute walking test will be conducted on all subjects in the published Six-minute Walking Guidelines, and the six-minute walking distance will be measured.
Measured: Each enrolled patient will be measured only once when enrollment.
Acute Exacerbations
The number, causes, treatment place, medications, costs and outcomes of acute exacerbations will be recorded.
Measured: Each enrolled patient will be measured only once when enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start7 Oct 2019
- Primary completionJul 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchial AsthmaStudies 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
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Suyun Li, Professor, Study director, The First Affiliated Hospital of Henan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128111
- Sponsor's protocol ID
- TCM syndrome of Asthma
- Status last verified
- Oct 2019
- First submitted
- 11 Sep 2019
- Last updated
- 23 Oct 2019
- 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 23 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma: An Observational Study
- ClinicalTrials.gov ID
- NCT04128111
- Acronym / sponsor ID
- TCM syndrome of Asthma
- Conditions
- Bronchial Asthma
- Keywords
- Bronchial Asthma, TCM Syndrome, Inflammation Phenotype, Biomarker
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Henan Provincial People's Hospital, Guangdong Provincial Hospital of Traditional Chinese Medicine
- Study start
- 7 Oct 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 16 Oct 2019 (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 aims to determine the TCM syndrome pattern and the distribution of inflammation phenotype in different stages of bronchial asthma; to explore the correlation between TCM syndrome and inflammation phenotype. Secondly screening biomarkers that can be recognized by TCM syndromes and inflammatory phenotypes of bronchial asthma, and provide a basis for individualized diagnosis and treatment of diseases.
Detailed description
The clinical heterogeneity of bronchial asthma was strong.The TCM syndrome was complicated and mostly treated on stage, type, excess and deficiency.The phenotype was numerous and more classified from inflammation type, clinical classification, internal phenotype, etc.The flammatory phenotype was the more common type.The pathological basis of asthma was closely related to the infiltration of inflammatory mediators such as Airway eosinophil cells, so it was important to find the specific biomarker. The correlation between TCM syndrome, inflammatory phenotype and its biomarker wsa not clear. So we put forward theoretical hypothesis:There was of correlation between TCM syndrome and inflammatory phenotype of asthma.The biological target was contributes to the confirmation for TCM syndrome and inflammatory phenotype.The following research was planned to be carried out: relying on the registration system of National TCM Clinical Research Base to enroll in 900 cases patients in the acute and remission period of asthma and healthy physical examination crowd, filling in the patient's general demographic data, disease status, lung function, TCM syndrome and score and collecting the sputum, exhaled gas, urine, peripheral venous serum specimens and biomarker to be tested on the same day. Based on the clinical research database, confirming syndrome and in phenotype, clarifying the correlation between syndrome and phenotype and selecting identifiable biomarker by using correlation analysis, principal component analysis, multiple regression analysis, neural network analysis and other methods.The research provided evidence for the study of the essence of syndrome and phenotype and provided evidence for individualized diagnosis and treatment of diseases.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Acute Exacerbation | – | –Exacerbations of asthma are episodes characterized by a progressive increase in symptoms of shortness of breath, cough, wheezing or chest tightness and progressive decrease in lung function, i.e. they represent a change from the patient's usual status that is sufficient to require a change in treatment. |
| Non-acute exacerbation | – | –Non-acute exacerbation of asthma includes chronic remission and clinical delays.Clinical remission stage refers to an absence of wheezing, chest tightness, cough and other symptoms for more than 1 year.Chronic duration refers to that symptoms, such as wheezing, chest tightness, cough and so on, attack at different frequency and different degrees every week. |
| Healthy Volunteer | – | –Health is not only the absence of disease or infirmity, but also a state of physical, mental, and social perfection. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The diagnosis and staging of bronchial asthma refer to"Chinese Guideline for The Prevention and Management of Bronchial Asthma (2016 edition)"and "The Chinese experts'consensus on the evaluation and management of asthma exacerbation"by Chinese Society of Respiratory Diseases and China Asthma Alliance. Reference Standard for Healthy Population The Concept of "Health" by the United Nations World Health Organization (WHO).The investigators will only enroll subjects in whom above diagnosis is firmly established.
Key inclusion criteria (4 listed)
- Patients with definite dignosis of bronchial asthma or healthy volunteer;
- Ages range from 18 years to 80 years old;
- Not anticipated in other clinical studies within 1 month before enrollment;
- Signed informed consent.
Key exclusion criteria (5 listed)
- Acute asthma exacerbation patients with respiratory failure, mechanical ventilation;
- Patients with unconsciousness, dementia, various mental disorders;
- Complicated with hematological malignancies , heart failure(Acute myocardial infarction, cardiac function grade 3 or above), severe liver or kidney diseases;
- Complicated with neuromuscular disorders affecting respiratory and motor function, unable to complete the six-minute walk test;
- People who are participating in other clinical trials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Inflammatory Phenotype
Time frame: Each enrolled patient will be measured only once when enrollment.
The inflammation phenotype will be determined by measuring the different proportions of eosinophils, neutrophils and mast cells in induced sputum.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%).
13 secondary outcomes
Biomarker
Time frame: Each enrolled patient will be measured only once when enrollment.
FeNO
Time frame: Each enrolled patient will be measured only once when enrollment.
Exhaled Breath Condensate（EBC）
Time frame: Each enrolled patient will be measured only once when enrollment.
Urine Specimen
Time frame: Each enrolled patient will be measured only once when enrollment.
Peripheral Venous Serum Specimens
Time frame: Each enrolled patient will be measured only once when enrollment.
TCM Syndrome
Time frame: Each enrolled patient will be measured only once when enrollment.
General demographic data
Time frame: Each enrolled patient will be measured only once when enrollment.
Disease Conditions
Time frame: Each enrolled patient will be measured only once when enrollment.
Asthma Control Test (ACT) Scores
Time frame: Each enrolled patient will be measured only once when enrollment.
ACQ-5 Scores
Time frame: Each enrolled patient will be measured only once when enrollment.
Lung function and diurnal variation rate of PEF
Time frame: Each enrolled patient will be measured only once when enrollment.
6-minute walk test
Time frame: Each enrolled patient will be measured only once when enrollment.
Acute Exacerbations
Time frame: Each enrolled patient will be measured only once when enrollment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2019.
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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. This study is not recruiting at the moment.
Suyun Li, Professor study director
The First Affiliated Hospital of Henan University of Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchial Asthma, run by Henan University of Traditional Chinese Medicine at 1 site in China.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 23 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mihang Wang, Professor (86-371-66248624, wmh107hn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammatory Phenotype (time frame: Each enrolled patient will be measured only once when enrollment.). 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 23 Oct 2019.