Exhaled Breath Condensate Biomarkers in CARAS

Preliminary Application and Evaluation of Exhaled Breath Condensate Biomarkers in Combined Allergic Rhinitis and Asthma Syndrome (CARAS)

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.

Study Overview

• Status: Recruiting
• Conditions: Combined Allergic Rhinitis and Asthma Syndrome
• Intervention / Treatment: Other: questionnaire survey

• Study Type: Observational
• Enrollment (Estimated): 270

Contacts and Locations

• Study Contact: Name: Yang Xie; Phone Number: 13526621325; Email: xieyanghn@163.com

Study Locations

• China
  • Zhengzhou
    • Henan, Zhengzhou, China
      • Recruiting
      • the First Affiliated Hospital of Henan University of Chinese Medicine
      • Contact: Yang Xie, Ph.D; Phone Number: +8613526621325; Email: xieyanghn@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• 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).

Description

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 Plan

How is the study designed?

Number of groups / cohorts

9

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; subjects fill out questionnaires
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; subjects fill out questionnaires
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; subjects fill out questionnaires
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; subjects fill out questionnaires
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; subjects fill out questionnaires
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; subjects fill out questionnaires
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; subjects fill out questionnaires
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; subjects fill out questionnaires
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; subjects fill out questionnaires

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Henan University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: August 21, 2024
• First Submitted That Met QC Criteria: August 23, 2024
• First Posted (Actual): August 27, 2024

Study Record Updates

• Last Update Posted (Actual): August 28, 2024
• Last Update Submitted That Met QC Criteria: August 27, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Biomarkers; EBC; CARAS; Combination of disease and evidence
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Disease; Bronchial Diseases; Otorhinolaryngologic Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Syndrome; Asthma; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: EBC biomarkers in CARAS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No