- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04128111
Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma
Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma: An Observational Study
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Mihang Wang, Professor
- Phone Number: 86-371-66248624
- Email: wmh107hn@163.com
Study Locations
-
-
Henan
-
Zhengzhou, Henan, China, 450000
- Recruiting
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
-
Contact:
- Minghang Wang, Professor
- Phone Number: 86-371-66248624
- Email: wmh107hn@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
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.
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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%).
|
Each enrolled patient will be measured only once when enrollment.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Biomarker
Time Frame: Each enrolled patient will be measured only once when enrollment.
|
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.
|
Each enrolled patient will be measured only once when enrollment.
|
FeNO
Time Frame: Each enrolled patient will be measured only once when enrollment.
|
Measurement of Exhaled Nitric Oxide by Swedish NIOX.
|
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.
|
EBC will be collected by EcoScreen, 8-isoprostaglandin, nitric oxide products and leukotrienes will be measured by ELISA.
|
Each enrolled patient will be measured only once when enrollment.
|
Urine Specimen
Time Frame: Each enrolled patient will be measured only once when enrollment.
|
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.
|
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.
|
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.
|
Each enrolled patient will be measured only once when enrollment.
|
TCM Syndrome
Time Frame: Each enrolled patient will be measured only once when enrollment.
|
According to the comprehensive analysis of four TCM diagnostic methods, the syndrome differentiation will be determined.
|
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.
|
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 enrolled patient will be measured only once when enrollment.
|
Disease Conditions
Time Frame: Each enrolled patient will be measured only once when enrollment.
|
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.
|
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.
|
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 enrolled patient will be measured only once when enrollment.
|
ACQ-5 Scores
Time Frame: Each enrolled patient will be measured only once when enrollment.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Each enrolled patient will be measured only once when enrollment.
|
Acute Exacerbations
Time Frame: Each enrolled patient will be measured only once when enrollment.
|
The number, causes, treatment place, medications, costs and outcomes of acute exacerbations will be recorded.
|
Each enrolled patient will be measured only once when enrollment.
|
Collaborators and Investigators
Collaborators
Investigators
- Study Director: Suyun Li, Professor, The First Affiliated Hospital of Henan University of Chinese Medicine
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TCM syndrome of Asthma
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Bronchial Asthma
-
Vanderbilt University Medical CenterNot yet recruitingAsthma in Children | Asthma Attack | Asthma Acute | Acute Asthma Exacerbation | Asthma; StatusUnited States
-
University of California, San FranciscoCompletedAsthma in Children | Asthma Attack | Asthma Acute | Asthma ChronicUnited States
-
SamA Pharmaceutical Co., LtdCompleted
-
Johann Wolfgang Goethe University HospitalCompleted
-
Value Outcomes Ltd.AstraZenecaCompletedAsthma, Bronchial | Bronchial Asthma | Asthma Chronic | Asthma; EosinophilicCzechia
-
AstraZenecaRecruitingBronchial Asthma (Only the Patients With Severe or Intractable Bronchial Asthma Which Could Not be Controlled With the Existing Therapy)Japan
-
Astellas Pharma IncAstellas Pharma Europe B.V.CompletedAsthma, Bronchial | Bronchial AsthmaRussian Federation, Poland, Germany, Ukraine, Czech Republic
-
Astellas Pharma IncAstellas Pharma Europe B.V.CompletedAsthma, Bronchial | Bronchial AsthmaRussian Federation, Hungary, Germany, Poland, Bulgaria, Ukraine, Czech Republic
-
Parc de Salut MarActive, not recruitingAsthma in Children | Persistent Asthma | Asthma ExacerbationSpain