Ignite Creation Date:
2025-12-24 @ 11:07 PM
Ignite Modification Date:
2026-02-20 @ 4:45 AM
Study NCT ID:
NCT02295969
Status:
COMPLETED
Last Update Posted:
2017-07-26
First Post:
2014-11-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observational Study of Oralair® in Children 5-9 Years With Grass-pollen-induced Allergic Rhinitis With/Without Conjunctivitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D003231', 'term': 'Conjunctivitis'}], 'ancestors': [{'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D003229', 'term': 'Conjunctival Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C587552', 'term': 'Sweet Vernal, orchard, Perennial Rye, Timothy and Kentucky Blue Grass Mixed Pollens Allergen Extract'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 307}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-07', 'completionDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-07-25', 'studyFirstSubmitDate': '2014-11-18', 'studyFirstSubmitQcDate': '2014-11-18', 'lastUpdatePostDateStruct': {'date': '2017-07-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-11-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All adverse events that started on or after the day the first dose of Oralair', 'timeFrame': 'During 30 days after the date of the first dose'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Rhinitis', 'Conjunctivitis', 'Grass pollen', 'Sublingual tablet', 'Allergen immunotherapy', 'Safety'], 'conditions': ['Allergy']}, 'referencesModule': {'references': [{'pmid': '31009701', 'type': 'DERIVED', 'citation': 'Gerstlauer M, Szepfalusi Z, Golden D, Geng B, de Blic J. Real-life safety of 5-grass pollen tablet in 5-to-9-year-old children with allergic rhinoconjunctivitis. Ann Allergy Asthma Immunol. 2019 Jul;123(1):70-80. doi: 10.1016/j.anai.2019.04.011. Epub 2019 Apr 19.'}]}, 'descriptionModule': {'briefSummary': 'Safety and tolerability of ORALAIR in children 5 to 9 years of age during the first 30 days of treatment.', 'detailedDescription': 'The purpose of this study is to further describe the safety and tolerability of ORALAIR tablets in children 5 to 9 years of age with grass-pollen-induced allergic rhinitis with or without conjunctivitis.\n\nPatients are followed for safety and tolerability during the first 30 treatment days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '9 Years', 'minimumAge': '5 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Outpatients, children 5 to 9 years of age prescribed ORALAIR for the treatment of grass-pollen-induced allergic rhinitis with or without conjunctivitis.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAllergen immunotherapy naive male or female outpatients aged 5 to 9 years (inclusive) prescribed ORALAIR.\n\nExclusion Criteria:\n\nPatients already participating in a clinical trial.'}, 'identificationModule': {'nctId': 'NCT02295969', 'briefTitle': 'Observational Study of Oralair® in Children 5-9 Years With Grass-pollen-induced Allergic Rhinitis With/Without Conjunctivitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Stallergenes Greer'}, 'officialTitle': 'An Observational Study of ORALAIR® (Grass Pollen Allergen Extract From: Cocksfoot, Sweet Vernal, Rye Grass, Meadow Grass, Timothy) Tablet for Sublingual Use in Children 5 to 9 Years of Age With Grass-pollen-induced Allergic Rhinitis With or Without Conjunctivitis', 'orgStudyIdInfo': {'id': 'SL74.14'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Oralair', 'type': 'DRUG', 'description': 'Observational study, Oralair is used as prescribed by the prescriber phycisian.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '86156', 'city': 'Augsburg', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Klinikum Augsburg, Klinik für Kinder und Jugendliche', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stallergenes Greer', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Venn Life Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}