Preliminary Application and Evaluation of Exhaled Breath Condensate Biomarkers in Combined Allergic Rhinitis and Asthma Syndrome (CARAS)
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Combined Allergic Rhinitis and Asthma Syndrome
- Sponsor
- Henan University of Traditional Chinese Medicine
- Enrollment
- 270
- Locations
- 1
- Primary Endpoint
- Immunoglobulin E (IgE)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Immunoglobulin E (IgE)
Time Frame: Basline
Airway inflammation will be assessed using the IgE.
Interleukin-2、4、5、13 (IL-2、4、5、13)
Time Frame: Basline
Airway inflammation will be assessed using the IL-2、4、5、13.
Interferon-γ (IFN-γ)
Time Frame: Basline
Airway inflammation will be assessed using the IFN-γ.
Tumor necrosis factor-β (TNF-β)
Time Frame: Basline
Airway inflammation will be assessed using the TNF-β.
Eosinophil cationic proteins (ECP)
Time Frame: Basline
Airway inflammation will be assessed using the ECP.
Secondary Outcomes
- Fractional exhaled nitric oxide (FeNO)(Basline)
- Forced vital capacity (FVC)(Basline)
- Forced expiratory volume in one second (FEV1)(Basline)
- Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)(Basline)
- FVC as the percentage of the predicted value (FVC%)(Basline)