Ignite Creation Date:
2025-12-25 @ 2:40 AM
Ignite Modification Date:
2025-12-30 @ 11:25 PM
Study NCT ID:
NCT05101733
Status:
UNKNOWN
Last Update Posted:
2022-04-12
First Post:
2021-09-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D009299', 'term': 'Nasal Provocation Tests'}, {'id': 'D010328', 'term': 'Patch Tests'}, {'id': 'D001800', 'term': 'Blood Specimen Collection'}], 'ancestors': [{'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012882', 'term': 'Skin Tests'}, {'id': 'D007159', 'term': 'Immunologic Tests'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-09', 'studyFirstSubmitDate': '2021-09-30', 'studyFirstSubmitQcDate': '2021-10-19', 'lastUpdatePostDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence, Immunoglobulin-E (IgE)-antibodies to selected Alternaria species', 'timeFrame': '12 months', 'description': 'Determine the prevalence of sensitization to multiple Alternaria species in the Austrian population'}], 'secondaryOutcomes': [{'measure': 'Cytokine-profile (e.g. Interleukin-13, Interleukin-5, Interleukin-10, TNFalpha, IFNgamma) upon Alt a 1 incubation', 'timeFrame': '12 months', 'description': 'Changes in the immun response when ligand-binding mononuclear cells from the blood to Alt a 1, characterized by the cytokine profile (Th1/Th2/regulatory) and the cell population (B- and T-cells, macrophages/monocytes)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allergy', 'Fungal allergy', 'Alternaria alternata'], 'conditions': ['Fungal Allergy', 'Allergy']}, 'descriptionModule': {'briefSummary': 'Mold allergies are becoming increasingly important among the population. Increasing amounts of fungal spores are analyzed in air-samples because of urbanization, industrialization of food products and climate change. Mold also grows indoor and hence lead to additional health complaints.\n\nAlternaria alternata, and its only major allergen Alt a 1, is the most important fungus for allergy sufferers. Alternaria alternata can not only cause allergic symptoms but can also cause intensified asthmatic symptoms.\n\nBesides Alternaria alternata, there are over 700 other species of the genus Alternaria. The influence of these other species on allergic symptoms is poorly understood.\n\nFurthermore, prevalence and incidence of an allergy to Alternaria alternata among the Austrian population is not known. Estimates range between 1-5% among the Austrian population.\n\nThis study aims to further investigate the incidence and characteristics of an allergy to Alternaria in Austria. This will be investigated with the help of participants (50 Alternaria allergy sufferers and 20 non allergic participants), spore counts in Austria and crowd-sourced symptom data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Participants are recruited with the help of advertisements on the social media pages of the Austrian Pollen Information Service and on the pollen diary app', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants will be healthy people over 18 years of age. Allergic participants should have an allergic reaction against Alternaria, visible in the Skin-Prick-Test. Furthermore symptom data in the pollen diary of the Austrian Pollen Information Service should be existing\n\nExclusion Criteria:\n\n* Subjects participating in a pharmacological study, pregnant subjects and subjects with an existing infectious- and/or autoimmune disease'}, 'identificationModule': {'nctId': 'NCT05101733', 'briefTitle': 'Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Vienna'}, 'officialTitle': 'Pilot Study Regarding Mold Allergy in Austria: Clinical Relevance of Alternaria Alternata and Related Species', 'orgStudyIdInfo': {'id': '1318/2021'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Alternaria allergy sufferers', 'description': '50 people suffering from an allergy to Alternaria. These participants receive a questionnaire, a Skin-Prick-Test, a blood draw and nasal provocation with collection of nasal secretion', 'interventionNames': ['Diagnostic Test: Nasal provocation', 'Diagnostic Test: Skin-Prick Test', 'Diagnostic Test: Blood draw', 'Diagnostic Test: Collection of nasal secretion']}, {'label': 'Non-allergic participants', 'description': 'Non allergic participants (20) receive a questionnaire, a blood draw and collection of nasal secretion', 'interventionNames': ['Diagnostic Test: Blood draw', 'Diagnostic Test: Collection of nasal secretion']}], 'interventions': [{'name': 'Nasal provocation', 'type': 'DIAGNOSTIC_TEST', 'description': 'Nasal provocation with Alternaria alternata extract. Changes in nasal mucosa are measured with a rhinomanometry device', 'armGroupLabels': ['Alternaria allergy sufferers']}, {'name': 'Skin-Prick Test', 'type': 'DIAGNOSTIC_TEST', 'description': 'Skin-Prick-Test is administered to determine an allergy against Alternaria', 'armGroupLabels': ['Alternaria allergy sufferers']}, {'name': 'Blood draw', 'type': 'DIAGNOSTIC_TEST', 'description': 'For further analysis', 'armGroupLabels': ['Alternaria allergy sufferers', 'Non-allergic participants']}, {'name': 'Collection of nasal secretion', 'type': 'DIAGNOSTIC_TEST', 'description': 'Allergy sufferers: After nasal provocation Non-allergics: After administration of isotonic nasal spray', 'armGroupLabels': ['Alternaria allergy sufferers', 'Non-allergic participants']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'facility': 'Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Markus Berger, Dr.', 'role': 'CONTACT', 'email': 'markus.berger@meduniwien.ac.at', 'phone': '+4369918939871'}], 'overallOfficials': [{'name': 'Erika Jensen-Jarolim, Univ.-Prof. Dr.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Department of Pathophysiology and Allergy Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Vienna', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. med. univ.', 'investigatorFullName': 'Dr. Markus Berger', 'investigatorAffiliation': 'Medical University of Vienna'}}}}