The First Affiliated Hospital of Henan University of Chinese Medicine
Henan, Zhengzhou, China
Location status: Recruiting
Recruiting
NCT Number: NCT06573450
Exhaled Breath Condensate Biomarkers in 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.
Recruiting
Interested in participating?
Request InfoKey information
Age range
18 year–80 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
questionnaire survey
Othersubjects fill out questionnaires
Primary outcomes
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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.
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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.
-
Immunoglobulin E (IgE)
Time frame: Basline
Airway inflammation will be assessed using the IgE.
Secondary outcomes
-
Fractional exhaled nitric oxide (FeNO)
Time frame: Basline
Higher FeNO values indicate higher airway inflammation.
-
Forced expiratory volume in one second (FEV1)
Time frame: Basline
Lung function will be assessed using the FEV1.
-
Forced vital capacity (FVC)
Time frame: Basline
Lung function will be assessed using the FEV1.
-
FVC as the percentage of the predicted value (FVC%)
Time frame: Basline
Lung function will be assessed using the FVC%.
-
Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)
Time frame: Basline
Lung function will be assessed using the FEV1/FVC.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Henan University of Traditional Chinese Medicine
Other
Registry information
Official study title
Preliminary Application and Evaluation of Exhaled Breath Condensate Biomarkers in Combined Allergic Rhinitis and Asthma Syndrome (CARAS)
Important dates
- Study start
- 2023
- Primary completion
- 2025
- Study completion
- 2025
- First posted
- Aug 27, 2024
- Registry last updated
- Aug 28, 2024
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.