Exhaled Breath Condensate Biomarkers in CARAS

Recruiting

• Conditions: Combined Allergic Rhinitis and Asthma Syndrome
• Interventions: Other: questionnaire survey

• Registration Number: NCT06573450
• Lead Sponsor: Henan University of Traditional Chinese Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-01
• Status Verified: 2024-08
• Study First Submitted: 2024-08-21
• Study First Submitted QC: 2024-08-23
• Study First Posted: 2024-08-27
• Last Update Submitted: 2024-08-27
• Last Update Posted: 2024-08-28
• Primary Completion: 2025-05-30
• Study Completion: 2025-05-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 270

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
chronic persistence CARAS	questionnaire survey	Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
clinical control BA	questionnaire survey	Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
persistent AR	questionnaire survey	Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
clinical control CARAS	questionnaire survey	Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
acute exacerbation CARAS	questionnaire survey	Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
chronic persistence BA	questionnaire survey	Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
intermittent AR	questionnaire survey	Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
acute exacerbation BA	questionnaire survey	Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.
healthy individuals	questionnaire survey	Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.

Primary Outcome Measures

Name	Time	Method
Immunoglobulin E (IgE)	Basline	Airway inflammation will be assessed using the IgE.
Interleukin-2、4、5、13 (IL-2、4、5、13)	Basline	Airway inflammation will be assessed using the IL-2、4、5、13.
Interferon-γ (IFN-γ)	Basline	Airway inflammation will be assessed using the IFN-γ.
Tumor necrosis factor-β (TNF-β)	Basline	Airway inflammation will be assessed using the TNF-β.
Eosinophil cationic proteins (ECP)	Basline	Airway inflammation will be assessed using the ECP.

Secondary Outcome Measures

Name	Time	Method
Fractional exhaled nitric oxide (FeNO)	Basline	Higher FeNO values indicate higher airway inflammation.
Forced vital capacity (FVC)	Basline	Lung function will be assessed using the FEV1.
Forced expiratory volume in one second (FEV1)	Basline	Lung function will be assessed using the FEV1.
Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)	Basline	Lung function will be assessed using the FEV1/FVC.
FVC as the percentage of the predicted value (FVC%)	Basline	Lung function will be assessed using the FVC%.

Trial Locations

Locations (1)

The First Affiliated Hospital of Henan University of Chinese Medicine; 🇨🇳 Henan, Zhengzhou, China