Viewing Study NCT01936818


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Ignite Modification Date: 2026-03-01 @ 12:17 AM
Study NCT ID: NCT01936818
Status: COMPLETED
Last Update Posted: 2015-10-22
First Post: 2013-09-03
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Study Evaluating Nasal Symptoms Induced by a Nasal Allergen Challenge (NAC) To House Dust Mite Allergen
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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-21', 'studyFirstSubmitDate': '2013-09-03', 'studyFirstSubmitQcDate': '2013-09-03', 'lastUpdatePostDateStruct': {'date': '2015-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TNSS= total nasal symptoms score', 'timeFrame': '15 minutes'}], 'secondaryOutcomes': [{'measure': 'Individual nasal symptoms', 'timeFrame': '15 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'A Multi-Center Study Evaluating the Nasal Allergic Symptomatology Induced by a Nasal Allergen Challenge (NAC) in a Dust Mite Population'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'subjects at least 18 years of age of either sex and any race', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be at least 18 years of age\n* positive ST to Dust Mite\n* history of allergic rhinitis\n\nExclusion Criteria:\n\n* no active infections\n* no disallowed medications\n* no nasal anatomical deformities or nasal surgical interventions in the past'}, 'identificationModule': {'nctId': 'NCT01936818', 'briefTitle': 'Study Evaluating Nasal Symptoms Induced by a Nasal Allergen Challenge (NAC) To House Dust Mite Allergen', 'organization': {'class': 'INDUSTRY', 'fullName': 'ORA, Inc.'}, 'orgStudyIdInfo': {'id': '13-100-0008'}}, 'contactsLocationsModule': {'locations': [{'zip': '01810', 'city': 'Andover', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ora Clinical Research Center', 'geoPoint': {'lat': 42.65843, 'lon': -71.137}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ORA, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}