Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT05655858
Status:
COMPLETED
Last Update Posted:
2025-10-03
First Post:
2022-12-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study of Allergic Rhinitis in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1004}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2024-03-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-30', 'studyFirstSubmitDate': '2022-12-01', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2025-10-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of children over 2 years of age with allergic rhinitis eligible for allergic immunotherapy', 'timeFrame': '1 year', 'description': 'Descriptive analysis : evaluation with data collected in the case report form about allergic rhinitis'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'Observational, cross-sectional, prospective, multicentric study in France with private paediatricians to describe the management of allergic rhinitis in children.', 'detailedDescription': 'Data collected about diagnostic, comorbidities, clinical history, management of allergic rhinitis using a patient paper case report form. There is only one visit per patient and investigators can include up to 20 patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '2 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1000 patients aged 2 to 18 years old with allergic rhinitis', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Under 18 years of age\n* With allergic rhinitis\n* Who's representative of the parental authority did not object to his child's participation after oral and written information and who agrees to participate\n\nExclusion Criteria:\n\n* Child or adolescent opposed to participate or collect his personal data"}, 'identificationModule': {'nctId': 'NCT05655858', 'acronym': 'ORACLE', 'briefTitle': 'Observational Study of Allergic Rhinitis in Children', 'organization': {'class': 'INDUSTRY', 'fullName': 'ALK-Abelló A/S'}, 'officialTitle': 'Observational Study of Allergic Rhinitis in Children', 'orgStudyIdInfo': {'id': '2022-A01596-37'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Management of allergic rhinitis', 'type': 'OTHER', 'description': 'Collection of patient data in real-life'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Necker-Enfants malades - AP-HP Service de Pneumologie et Allergologie Pédiatriques', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ALK-Abelló A/S', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}