[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100429235":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":26,"locations":33,"responsibleParty":56,"collaborators":59,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":20,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":20,"enrollmentInfo":71,"targetDuration":20,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":20,"overallStatus":36,"whyStopped":20,"lastUpdateSubmitDate":81,"lastUpdatePostDateStruct":82,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":90},{"fullName":5,"class":6},"London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dupilumab group","EXPERIMENTAL","Patients with CRSwNP will have an initial dose of 600 mg of dupilumab, and 5 additional doses of 300mg every 4 weeks for 6 months.",[13],"Drug: Dupilumab 300 MG\u002F2 ML Subcutaneous Solution [DUPIXENT]",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Dupilumab 300 MG\u002F2 ML Subcutaneous Solution [DUPIXENT]","Dupilumab will be administered subcutaneously for 6 months (1 initial 600mg dose + 5 300mg doses every 4 weeks)",[9],null,[22],{"name":23,"affiliation":24,"role":25},"Leigh J Sowerby, MD, FRCS","St. Joseph's Hospital London, ON, Canada","PRINCIPAL_INVESTIGATOR",[27],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Cristian Dihel, MD","CONTACT","+15196466100","61125","cristian.dihel@sjhc.london.on.ca",[34],{"facility":35,"status":36,"city":37,"state":38,"zip":39,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"St. Joseph's Health Care","RECRUITING","London","Ontario","N5A 4V2","Canada","CA",{"type":43,"coordinates":44},"Point",[45,46],-81.23304,42.98339,{"lat":46,"lon":45},[49,51,53],{"name":50,"role":29,"phone":20,"phoneExt":20,"email":20},"Leigh J Sowerby",{"name":52,"role":25,"phone":20,"phoneExt":20,"email":20},"Leigh J Sowerby, MD",{"name":54,"role":55,"phone":20,"phoneExt":20,"email":20},"Brian Rotenberg, MD","SUB_INVESTIGATOR",{"type":25,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Leigh Sowerby","Principal Investigator",[60],{"name":61,"class":6},"Mount Sinai Hospital, Canada","100429235","phase-4-olfactory-outcomes-of-dupilumab-treatment-for-nasal-polyposis-100429235",false,"NCT04869436","Olfactory Outcomes of Dupilumab Treatment for Nasal Polyposis","The 'Real World' Olfactory Outcomes Treating Nasal Polyposis With Dupilumab","Inclusion Criteria:\n\n* Patients older than 18 years old\n* Chronic rhinosinusitis with Nasal Polyps\n* Olfactory loss\n* Clinical indication for treatment with Dupilumab\n\nExclusion Criteria:\n\nPatients with olfactory loss from other causes such as:\n\n* Sinonasal malignancies\n* Trauma\n* Idiopathic olfactory loss\n* Use of cocaine\n* COVID-19 related olfactory loss\n* Pregnancy","ALL","18 Years",{"count":72,"type":73},27,"ESTIMATED","INTERVENTIONAL",[76],"PHASE4","The study aims to investigate the olfactory TDI score (Threshold, Discrimination, Identification) using the Sniffin' sticks test for patients with chronic rhinosinusitis with nasal polyps (CRSwNP) on dupilumab. Twenty-seven adult patients will be followed up during the treatment with dupilumab on three visits to the Otolaryngology Clinic (Baseline, 3 months and 6 months).\n\nThe primary endpoint will be the TDI score. Nasal polyp score, Quality of Olfactory Disorders - negative symptoms (QOD-NS symptom scores), SNOT-22 will be secondary endpoints.",[79,80],"Chronic Rhinosinusitis With Nasal Polyps","Olfactory Disorder","2024-12-18",{"date":83,"type":84},"2024-12-20","ACTUAL",{"date":86,"type":84},"2021-07-19",{"date":88,"type":73},"2025-12-01",{"name":5,"class":6},1]