Exhaled Breath Condensate Biomarkers in CARAS

NCT06573450 | Recruiting DMC

• 1 other identifier: EBC biomarkers in CARAS
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

To explore the differences in the expression of biomarkers in different sample types between the healthy population and different subgroups of the disease, and to screen for potential biomarkers in a more simple, direct and objective way. To screen the biomarkers that can be identified by CARAS Chinese medicine symptoms and different stages, and to provide a reference basis for individualised diagnosis and treatment of the disease.

Conditions

Combined Allergic Rhinitis and Asthma Syndrome

Keywords

CARAS; EBC; Biomarkers; Combination of disease and evidence

Outcome Measures

Primary Outcomes (5)

• Interleukin-2、4、5、13 (IL-2、4、5、13)

  Airway inflammation will be assessed using the IL-2、4、5、13.

  Basline

• Interferon-γ (IFN-γ)

  Airway inflammation will be assessed using the IFN-γ.

  Basline

• Tumor necrosis factor-β (TNF-β)

  Airway inflammation will be assessed using the TNF-β.

  Basline

• Eosinophil cationic proteins (ECP)

  Airway inflammation will be assessed using the ECP.

  Basline

• Immunoglobulin E (IgE)

  Airway inflammation will be assessed using the IgE.

  Basline

Secondary Outcomes (5)

• Fractional exhaled nitric oxide (FeNO)

  Basline

• Forced expiratory volume in one second (FEV1)

  Basline

• Forced vital capacity (FVC)

  Basline

• FVC as the percentage of the predicted value (FVC%)

  Basline

• Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)

  Basline

Study Arms (9)

acute exacerbation CARAS

Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.

Other: questionnaire survey

chronic persistence CARAS

Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.

Other: questionnaire survey

clinical control CARAS

Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.

Other: questionnaire survey

acute exacerbation BA

Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.

Other: questionnaire survey

chronic persistence BA

Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.

Other: questionnaire survey

clinical control BA

Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.

Other: questionnaire survey

intermittent AR

Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.

Other: questionnaire survey

persistent AR

Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.

Other: questionnaire survey

healthy individuals

Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.

Other: questionnaire survey

Interventions

questionnaire survey OTHER

subjects fill out questionnaires

acute exacerbation BA; acute exacerbation CARAS; chronic persistence BA; chronic persistence CARAS; clinical control BA; clinical control CARAS; healthy individuals; intermittent AR; persistent AR

Eligibility Criteria

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

Study Population

Allergic rhinitis (AR) is a common chronic inflammatory disease of the upper respiratory tract with paroxysmal sneezing, nasal congestion, watery nasal discharge and nasal itching as the main clinical symptoms. Bronchial asthma (BA) is a complex heterogeneous chronic inflammatory disease of the bronchi with recurrent symptoms of wheezing, shortness of breath, chest tightness, and coughing.AR usually coexists with BA, and about 70-90% of patients with asthma develop rhinitis, and about 40% of patients with rhinitis develop asthma. When AR and BA occur together, it is called combined allergic rhinitis and asthma syndrome (CARAS).

You may qualify if:

• Patients with AR, BA and CARAS who meet the Western medical diagnostic criteria;
• Chinese medical evidence consistent with lung qi deficiency evidence, phlegm-heat congestion of the lung evidence, or wind-heat offending the lung evidence;
• Age 18 to 80 years;
• Voluntarily accepted the study and signed an informed consent form;
• Not participated in other clinical studies within 1 month before enrollment.

You may not qualify if:

• Patients with combined vasomotor rhinitis and eosinophilic non-allergic rhinitis, other non-allergic rhinitis diseases that can cause symptoms such as nasal congestion and runny nose;
• Patients who are participating in other drug trials;
• Patients with a combination of other serious systemic diseases;
• Pregnant or lactating women;
• Patients with confusion, disorders of consciousness, dementia, and various psychiatric disorders.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead

Study Sites (1)

The First Affiliated Hospital of Henan University of Chinese Medicine

Henan, Zhengzhou, China

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Central Study Contacts

Yang Xie

CONTACT

13526621325; xieyanghn@163.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 21, 2024
• First Posted: August 27, 2024
• Study Start: April 1, 2023
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: August 28, 2024

Record last verified: 2024-08

Locations

CN (1)