Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-09 @ 3:24 AM
Study NCT ID:
NCT02377895
Status:
COMPLETED
Last Update Posted:
2017-01-26
First Post:
2015-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Allergen Biocube Study Evaluating Efficacy and Safety of Nasapaque Nasal Solution in Adult Subjects With Allergic Rhinitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006255', 'term': 'Rhinitis, Allergic, Seasonal'}], 'ancestors': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}, {'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': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 73}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'dispFirstSubmitDate': '2017-01-25', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2015-02-27', 'dispFirstSubmitQcDate': '2017-01-25', 'studyFirstSubmitQcDate': '2015-03-03', 'dispFirstPostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-01-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'TNSS Total Nasal Symptom Score', 'timeFrame': 'Day 1 and Day 8'}], 'secondaryOutcomes': [{'measure': 'Nasal Inspiratory Flow', 'timeFrame': 'Day 1 and Day 8'}, {'measure': 'Nasal Inflammation Score', 'timeFrame': 'Day 1 and Day 8'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Seasonal Allergic Rhinitis']}, 'referencesModule': {'references': [{'pmid': '30881050', 'type': 'DERIVED', 'citation': 'Gomes PJ, Abelson MB, Stein L, Viirre E, Villafranca JE, Lasser EC. Iodixanol nasal solution reduces allergic rhinoconjunctivitis signs and symptoms in Allergen BioCube(R): a randomized clinical trial. J Asthma Allergy. 2019 Mar 1;12:71-81. doi: 10.2147/JAA.S150251. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': 'Single-center, double-masked, randomized, placebo-controlled, parallel-group, efficacy and safety study using the Allergen BioCube (ABC).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Must be 18 years of age and provide written informed consent and sign the HIPAA form\n* Must have history of allergic rhinitis\n* Must have positive response to Allergen BioCube\n\nKey Exclusion Criteria:\n\n* Must not have a significant illness such as moderate to severe allergic asthmatic reactions\n* Must not have compromised lung function\n* Must not use any disallowed medications\n* Must not have been in an investigational study in the last 30 days'}, 'identificationModule': {'nctId': 'NCT02377895', 'briefTitle': 'Allergen Biocube Study Evaluating Efficacy and Safety of Nasapaque Nasal Solution in Adult Subjects With Allergic Rhinitis', 'organization': {'class': 'INDUSTRY', 'fullName': '3E Therapeutics Corporation'}, 'officialTitle': 'A Single-Center, Double-Masked, Randomized, Placebo-Controlled, Parallel-Group Allergen BioCube Study Evaluating the Efficacy and Safety of Nasapaque Nasal Solution in a Population of Adult Subjects With Seasonal Allergic Rhinitis', 'orgStudyIdInfo': {'id': '14-100-0008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nasapaque Nasal Solution', 'description': '250 ul in each nostril at Day 1 and Day 8', 'interventionNames': ['Drug: Nasapaque Nasal Solution']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo Saline Nasal Solution', 'description': '250 ul in each nostril at Day 1 and Day 8', 'interventionNames': ['Drug: Placebo Saline Nasal Solution']}], 'interventions': [{'name': 'Nasapaque Nasal Solution', 'type': 'DRUG', 'armGroupLabels': ['Nasapaque Nasal Solution']}, {'name': 'Placebo Saline Nasal Solution', 'type': 'DRUG', 'armGroupLabels': ['Placebo Saline Nasal Solution']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': '3E Therapeutics Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'ORA, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}