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Exhaled Breath Condensate Biomarkers in CARAS

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06573450
Enrollment
270
Registered
2024-08-27
Start date
2023-04-01
Completion date
2025-05-30
Last updated
2024-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Combined Allergic Rhinitis and Asthma Syndrome

Keywords

CARAS, EBC, Biomarkers, Combination of disease and evidence

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.

Interventions

OTHERquestionnaire survey

subjects fill out questionnaires

Sponsors

Henan University of Traditional Chinese Medicine
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Fractional exhaled nitric oxide (FeNO)BaslineHigher FeNO values indicate higher airway inflammation.
Forced expiratory volume in one second (FEV1)BaslineLung function will be assessed using the FEV1.
Forced vital capacity (FVC)BaslineLung function will be assessed using the FEV1.
FVC as the percentage of the predicted value (FVC%)BaslineLung function will be assessed using the FVC%.
Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)BaslineLung function will be assessed using the FEV1/FVC.

Countries

China

Contacts

Primary ContactYang Xie
xieyanghn@163.com13526621325

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026