Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2025-12-28 @ 3:37 AM
Study NCT ID:
NCT01503957
Status:
COMPLETED
Last Update Posted:
2012-10-26
First Post:
2011-12-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Nasya in Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], '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': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000028', 'term': 'Abortion, Induced'}], 'ancestors': [{'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-25', 'studyFirstSubmitDate': '2011-12-27', 'studyFirstSubmitQcDate': '2012-01-02', 'lastUpdatePostDateStruct': {'date': '2012-10-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Total Nasal Symptom Score', 'timeFrame': '75 minutes'}], 'secondaryOutcomes': [{'measure': 'Difference in Total Nasal Symptom Score', 'timeFrame': 'Up to 240 minutes'}, {'measure': 'Difference in Total Ocular Symptom Score', 'timeFrame': 'Up to 240 minutes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Allergic rhinitis', 'Allergen', 'Allergy', 'Dustmite'], 'conditions': ['Allergic Rhinitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate safety and efficacy of Nasya in reducing symptoms of persistent allergic rhinitis when applied before allergen challenge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* History of persistent allergic rhinitis due to house dust mite allergy ≥ 2 years\n* Written informed consent\n\nExclusion Criteria:\n\n* Clinically significant disease that could interfere with the evaluation of study medication\n* Participation in other studies within the last 4 weeks / during the study'}, 'identificationModule': {'nctId': 'NCT01503957', 'briefTitle': 'Nasya in Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'InQpharm Group'}, 'officialTitle': 'Double-blind, Randomized, Placebo-controlled, Crossover Clinical Investigation to Evaluate Safety and Efficacy of Nasya in Reducing Symptoms of Allergic Rhinitis When Applied Before Allergen Challenge', 'orgStudyIdInfo': {'id': 'INQ/023411'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Saline solution', 'description': 'Nasal spray', 'interventionNames': ['Device: Saline solution']}, {'type': 'EXPERIMENTAL', 'label': 'Nasya', 'description': 'Thixotropic nasal spray suspension', 'interventionNames': ['Device: Nasya']}], 'interventions': [{'name': 'Nasya', 'type': 'DEVICE', 'description': 'Thixotropic nasal spray suspension, 2 sprays in each nostril', 'armGroupLabels': ['Nasya']}, {'name': 'Saline solution', 'type': 'DEVICE', 'description': 'Nasal spray, 2 sprays in each nostril', 'armGroupLabels': ['Saline solution']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10117', 'city': 'Berlin', 'state': 'State of Berlin', 'country': 'Germany', 'facility': 'Campus Charité Mitte Klinik und Poliklinik für Hals-, Nasen-, Ohren- heilkunde Charité - Universitätsmedizin Berlin, Charitéplatz 1', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Minoo Lenarz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Charite University, Berlin, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'InQpharm Group', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}