Clinical trial NCT06573450: Exhaled Breath Condensate Biomarkers in CARAS
Official title: Preliminary Application and Evaluation of Exhaled Breath Condensate Biomarkers in Combined Allergic Rhinitis and Asthma Syndrome (CARAS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Combined Allergic Rhinitis and Asthma Syndrome
Keywords: CARAS
EBC
Biomarkers
Combination of disease and evidence
Lead sponsor: Henan University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2024-08-27
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
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).

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.


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.

Primary outcomes:
measure: Interleukin-2、4、5、13 (IL-2、4、5、13)
timeFrame: Basline
measure: Interferon-γ (IFN-γ)
timeFrame: Basline
measure: Tumor necrosis factor-β (TNF-β)
timeFrame: Basline
measure: Eosinophil cationic proteins (ECP)
timeFrame: Basline
measure: Immunoglobulin E (IgE)
timeFrame: Basline
Secondary outcomes:
measure: Fractional exhaled nitric oxide (FeNO)
timeFrame: Basline
measure: Forced expiratory volume in one second (FEV1)
timeFrame: Basline
measure: Forced vital capacity (FVC)
timeFrame: Basline
measure: FVC as the percentage of the predicted value (FVC%)
timeFrame: Basline
measure: Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)
timeFrame: Basline
Other outcomes:
Locations:
city: Henan
country: China
facility: The First Affiliated Hospital of Henan University of Chinese Medicine
state: Zhengzhou
Study officials:
References: