Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2026-01-04 @ 2:08 PM
Study NCT ID:
NCT06573450
Status:
RECRUITING
Last Update Posted:
2024-08-28
First Post:
2024-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exhaled Breath Condensate Biomarkers in CARAS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 270}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-27', 'studyFirstSubmitDate': '2024-08-21', 'studyFirstSubmitQcDate': '2024-08-23', 'lastUpdatePostDateStruct': {'date': '2024-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Interleukin-2、4、5、13 (IL-2、4、5、13)', 'timeFrame': 'Basline', 'description': 'Airway inflammation will be assessed using the IL-2、4、5、13.'}, {'measure': 'Interferon-γ (IFN-γ)', 'timeFrame': 'Basline', 'description': 'Airway inflammation will be assessed using the IFN-γ.'}, {'measure': 'Tumor necrosis factor-β (TNF-β)', 'timeFrame': 'Basline', 'description': 'Airway inflammation will be assessed using the TNF-β.'}, {'measure': 'Eosinophil cationic proteins (ECP)', 'timeFrame': 'Basline', 'description': 'Airway inflammation will be assessed using the ECP.'}, {'measure': 'Immunoglobulin E (IgE)', 'timeFrame': 'Basline', 'description': 'Airway inflammation will be assessed using the IgE.'}], 'secondaryOutcomes': [{'measure': 'Fractional exhaled nitric oxide (FeNO)', 'timeFrame': 'Basline', 'description': 'Higher FeNO values indicate higher airway inflammation.'}, {'measure': 'Forced expiratory volume in one second (FEV1)', 'timeFrame': 'Basline', 'description': 'Lung function will be assessed using the FEV1.'}, {'measure': 'Forced vital capacity (FVC)', 'timeFrame': 'Basline', 'description': 'Lung function will be assessed using the FEV1.'}, {'measure': 'FVC as the percentage of the predicted value (FVC%)', 'timeFrame': 'Basline', 'description': 'Lung function will be assessed using the FVC%.'}, {'measure': 'Forced expiratory volume in one second / forced vital capacity (FEV1/FVC)', 'timeFrame': 'Basline', 'description': 'Lung function will be assessed using the FEV1/FVC.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CARAS', 'EBC', 'Biomarkers', 'Combination of disease and evidence'], 'conditions': ['Combined Allergic Rhinitis and Asthma Syndrome']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with AR, BA and CARAS who meet the Western medical diagnostic criteria;\n* Chinese medical evidence consistent with lung qi deficiency evidence, phlegm-heat congestion of the lung evidence, or wind-heat offending the lung evidence;\n* Age 18 to 80 years;\n* Voluntarily accepted the study and signed an informed consent form;\n* Not participated in other clinical studies within 1 month before enrollment.\n\nExclusion Criteria:\n\n* 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;\n* Patients who are participating in other drug trials;\n* Patients with a combination of other serious systemic diseases;\n* Pregnant or lactating women;\n* Patients with confusion, disorders of consciousness, dementia, and various psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT06573450', 'briefTitle': 'Exhaled Breath Condensate Biomarkers in CARAS', 'organization': {'class': 'OTHER', 'fullName': 'Henan University of Traditional Chinese Medicine'}, 'officialTitle': 'Preliminary Application and Evaluation of Exhaled Breath Condensate Biomarkers in Combined Allergic Rhinitis and Asthma Syndrome (CARAS)', 'orgStudyIdInfo': {'id': 'EBC biomarkers in CARAS'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute exacerbation CARAS', 'description': 'Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.', 'interventionNames': ['Other: questionnaire survey']}, {'label': 'chronic persistence CARAS', 'description': 'Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.', 'interventionNames': ['Other: questionnaire survey']}, {'label': 'clinical control CARAS', 'description': 'Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.', 'interventionNames': ['Other: questionnaire survey']}, {'label': 'acute exacerbation BA', 'description': 'Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.', 'interventionNames': ['Other: questionnaire survey']}, {'label': 'chronic persistence BA', 'description': 'Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.', 'interventionNames': ['Other: questionnaire survey']}, {'label': 'clinical control BA', 'description': 'Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.', 'interventionNames': ['Other: questionnaire survey']}, {'label': 'intermittent AR', 'description': 'Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.', 'interventionNames': ['Other: questionnaire survey']}, {'label': 'persistent AR', 'description': 'Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.', 'interventionNames': ['Other: questionnaire survey']}, {'label': 'healthy individuals', 'description': 'Thirty subjects were included. No intervention was performed and only relevant patient information, blood and exhaled breath condensate were collected.', 'interventionNames': ['Other: questionnaire survey']}], 'interventions': [{'name': 'questionnaire survey', 'type': 'OTHER', 'description': 'subjects fill out questionnaires', 'armGroupLabels': ['acute exacerbation BA', 'acute exacerbation CARAS', 'chronic persistence BA', 'chronic persistence CARAS', 'clinical control BA', 'clinical control CARAS', 'healthy individuals', 'intermittent AR', 'persistent AR']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Henan', 'state': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yang Xie, Ph.D', 'role': 'CONTACT', 'email': 'xieyanghn@163.com', 'phone': '+8613526621325'}], 'facility': 'The First Affiliated Hospital of Henan University of Chinese Medicine', 'geoPoint': {'lat': 37.92189, 'lon': 112.22494}}], 'centralContacts': [{'name': 'Yang Xie', 'role': 'CONTACT', 'email': 'xieyanghn@163.com', 'phone': '13526621325'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Henan University of Traditional Chinese Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}