Exhaled Breath Condensate Biomarkers in CARAS
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-80
SponsorHenan University of Traditional Chinese Medicine
About this trial
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
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial 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).
Trial design
Design model
Other
Time perspective
Cross-sectional
Treatments tested in this trial
questionnaire survey
Other interventionsubjects fill out questionnaires
Treatment groups
270 Participants
are divided into 9 treatment groups9
Treatment groupsSee each treatment group below.
Group A: acute exacerbation CARAS1 intervention
Group B: chronic persistence CARAS1 intervention
Group C: clinical control CARAS1 intervention
Group D: acute exacerbation BA1 intervention
Group E: chronic persistence BA1 intervention
Group F: clinical control BA1 intervention
Group G: intermittent AR1 intervention
Group H: persistent AR1 intervention
Group I: healthy individuals1 intervention
Trial outcomes
Primary outcomes
1
Interleukin-2、4、5、13 (IL-2、4、5、13)
Airway inflammation will be assessed using the IL-2、4、5、13.
Time frame
Basline2
Interferon-γ (IFN-γ)
Airway inflammation will be assessed using the IFN-γ.
Time frame
Basline3
Tumor necrosis factor-β (TNF-β)
Airway inflammation will be assessed using the TNF-β.
Time frame
Basline4
Eosinophil cationic proteins (ECP)
Airway inflammation will be assessed using the ECP.
Time frame
BaslineSecondary outcomes
1
Fractional exhaled nitric oxide (FeNO)
Higher FeNO values indicate higher airway inflammation.
Time frame
Basline2
Forced expiratory volume in one second (FEV1)
Lung function will be assessed using the FEV1.
Time frame
Basline3
Forced vital capacity (FVC)
Lung function will be assessed using the FEV1.
Time frame
Basline4
FVC as the percentage of the predicted value (FVC%)
Lung function will be assessed using the FVC%.
Time frame
BaslineSponsors and contacts
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Source ClinicalTrials.gov