Study on the Correlation Between TCM Syndrome, Inflammatory Phenotype and Biomarker of Bronchial Asthma

NCT04128111 | Unknown DMC

• 1 other identifier: TCM syndrome of Asthma
• Study Type: observational
• Target: 900
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bronchial Asthma

Keywords

Bronchial Asthma; TCM Syndrome; Inflammation Phenotype; Biomarker

Outcome Measures

Primary Outcomes (1)

• 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%).

  Each enrolled patient will be measured only once when enrollment.

Secondary Outcomes (13)

• Biomarker

  Each enrolled patient will be measured only once when enrollment.

• FeNO

  Each enrolled patient will be measured only once when enrollment.

• Exhaled Breath Condensate（EBC）

  Each enrolled patient will be measured only once when enrollment.

• Urine Specimen

  Each enrolled patient will be measured only once when enrollment.

• Peripheral Venous Serum Specimens

  Each enrolled patient will be measured only once when enrollment.

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• Henan Provincial People's Hospital: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator

Study Sites (1)

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Zhengzhou, Henan, 450000, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

1.The inflammation phenotype will be determined by measuring the different proportions of eosinophils, neutrophils and mast cells in induced sputum.2.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.3.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.

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Suyun Li, Professor

  The First Affiliated Hospital of Henan University of Chinese Medicine

  STUDY DIRECTOR

Central Study Contacts

Mihang Wang, Professor

CONTACT

86-371-66248624; wmh107hn@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: September 11, 2019
• First Posted: October 16, 2019
• Study Start: October 7, 2019
• Primary Completion: July 1, 2022
• Study Completion: December 1, 2022
• Last Updated: October 23, 2019

Record last verified: 2019-10

Locations

CN (1)