Ignite Creation Date:
2025-12-24 @ 9:08 PM
Ignite Modification Date:
2026-01-05 @ 1:19 PM
Study NCT ID:
NCT06892704
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-03-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Olfactory Cleft Obstruction and Electrophysiological Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000086582', 'term': 'Anosmia'}], 'ancestors': [{'id': 'D000857', 'term': 'Olfaction Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Nasal secretions, Exhaled Breath Condensate, Tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-12', 'studyFirstSubmitDate': '2025-03-19', 'studyFirstSubmitQcDate': '2025-03-19', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Status change of the Brief Smell Identification Test', 'timeFrame': '26 weeks', 'description': 'The brief smell identification test will be administered and patients classified into normal/age-related deficit vs abnormal.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dupilumab', 'Chronic Rhinosinusitis with Nasal Polyps', 'Smell Loss', 'Electrophysiology'], 'conditions': ['Chronic Rhinosinusitis Phenotype With Nasal Polyps (CRSwNP)', 'Smell Loss']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to learn what can predict the return of the sense of smell in patients with chronic rhinosinusitis with nasal polyps being treated with dupilumab. The main questions it aims to answer are:\n\n1. Does obstruction of the olfactory cleft predict return of the sense of smell?\n2. Do electrophysiological signals generated by breathing and sniffing behavior predict return of the sense of smell?\n\nParticipants starting dupilumab will undergo assessment for their degree of olfactory cleft obstruction, and an electrophysiologic assessment of their olfactory cleft and be followed over 6 months of treatment with dupilumab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a well documented history of CRSwNP who had prior endoscopic sinus surgery who experience and are assessed to have olfactory deficit.', 'healthyVolunteers': False, 'eligibilityCriteria': '* Well documented history of CRSwNP\n* BSIT age/sex classified as "abnormal" score\n* Self-reported stable olfactory deficit of moderate to severe quality \\> 3 months\n* Prior endoscopic sinus surgery \\>3 months, \\<10 years prior'}, 'identificationModule': {'nctId': 'NCT06892704', 'briefTitle': 'Olfactory Cleft Obstruction and Electrophysiological Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Olfactory Cleft Obstruction and Electrophysiological Olfactory Bulb Generated Beta Field Potentials Predict Olfactory Restoration by Dupilumab in CRSwNP Patients.', 'orgStudyIdInfo': {'id': 'STU0022296'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Dupilumab Treatment', 'description': 'Patients who had prior endoscopic sinus surgery for CRSwNP with persistent smell loss initiating dupilumab', 'interventionNames': ['Drug: Dupilumab - Standard Dose']}], 'interventions': [{'name': 'Dupilumab - Standard Dose', 'type': 'DRUG', 'description': '24 weeks of dupilumab 300mg q2 weeks', 'armGroupLabels': ['Dupilumab Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Aditi Agarwal, MBBS, MSCI', 'role': 'CONTACT', 'email': 'aditi.agarwal@northwestern.edu', 'phone': '312-695-8182'}, {'name': 'Bruce Tan, MD MS', 'role': 'CONTACT', 'email': 'btan@nm.org', 'phone': '312 6958182'}, {'name': 'Bruce Tan, MD, MS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northwestern University Feinberg School of Medicine', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Clinical Coordinator', 'role': 'CONTACT', 'email': 'aditi.agarwal@northwestern.edu', 'phone': '312 6958182'}, {'name': 'Bruce Tan, MD', 'role': 'CONTACT', 'email': 'btan@nm.org', 'phone': '312 6958182'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'ipdSharing': 'YES', 'description': 'IPD underlying publication'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sanofi', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}