[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100446525":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":22,"centralContacts":26,"locations":37,"responsibleParty":56,"collaborators":59,"id":63,"slug":64,"hasResults":65,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":31,"eligibilityCriteria":69,"healthyVolunteers":65,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":31,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":40,"whyStopped":31,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"University of Virginia","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Dupilumab treatment","EXPERIMENTAL","Treatment with dupilumab to demonstrate decreased staph prevalence and improve microbial diversity",[13],"Drug: Dupilumab Prefilled Syringe",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","Dupilumab Prefilled Syringe","Dupilumab 300 mg",[9],[21],"DUPIXENT",[23],{"name":24,"affiliation":5,"role":25},"Larry C Borish, MD","PRINCIPAL_INVESTIGATOR",[27,33],{"name":28,"role":29,"phone":30,"phoneExt":31,"email":32},"Kristin W Wavell Shifflett, BS","CONTACT","4349246874",null,"kww7d@virginia.edu",{"name":34,"role":29,"phone":35,"phoneExt":31,"email":36},"Deborah Murphy, BSN","4349823510","ddm9q@virginia.edu",[38],{"facility":39,"status":40,"city":41,"state":42,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"University of Virginia Health System","RECRUITING","Charlottesville","Virginia","22908","United States","US",{"type":47,"coordinates":48},"Point",[49,50],-78.47668,38.02931,{"lat":50,"lon":49},[53],{"name":54,"role":29,"phone":55,"phoneExt":31,"email":36},"Deb Murphy, BSN","434-982-3510",{"type":25,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Larry Borish, MD","Professor of Medicine and Microbiology",[60],{"name":61,"class":62},"Regeneron Pharmaceuticals","INDUSTRY","100446525","phase-4-interleukin-4ra-blockade-by-dupilumab-decreases-staphylococcus-colonization-and-increases-microbial-diversity-in-crswnp-100446525",false,"NCT05094570","Interleukin-4Ra Blockade by Dupilumab Decreases Staphylococcus Colonization and Increases Microbial Diversity in CRSwNP","Interleukin-4Ralpha Blockade by Dupilumab Decreases Staphylococcus Aureus Colonization and Increases Microbial Diversity in Chronic Rhinosinusitis With Nasal Polyposis (CRSwNP)","Inclusion Criteria: • Adults, ages 18-65\n\n* History of CRSwNP including subjects with AERD\n* Sinonasal culture demonstrating staph aureus at visit 1\n* History of FESS with patent sinus ostia sufficient to obtain culture and tissue samples from the middle meatus\n* Asthma, if present, should be well controlled\n* Atopic dermatitis, if present, should be well controlled\n* Use of nasal saline irrigation and stable dosing (\\>1 month) of topical corticosteroids is permitted\n* Intent of the physicians caring to start dupilumab therapy as part of subject's standard of care\n* Subject meets FDA approved criteria for the use of dupilumab for nasal polyps\n\nExclusion Criteria:\n\n* Concurrent serious medical problem\n* Uncontrolled asthma (ACT \\\u003C20 at screening visit)\n* Recent (within 60 days) use of oral corticosteroids\n* Recent (within 60 days) urgent care, ED visit, or hospitalization for asthma\n* Current smoker or has smoked \\>10 pack-years\n* Biologic therapy including asthma biologic therapy in last 3 months\n* Recent (within 1 month) change in CRS medical treatment (topical steroids, surfactants, irrigation protocol, etc. including changes in delivery volume or delivery methodology)\n* Recent (within 6 weeks) upper respiratory infection\n* Antibiotics within 6 weeks\n* Pregnant or breast-feeding women\n* Any contraindication to the use of dupilumab including hypersensitivity on previous administration","ALL","18 Years","65 Years",{"count":74,"type":75},20,"ESTIMATED","INTERVENTIONAL",[78],"PHASE4","Hypothesis: The investigators hypothesize that in patients with CRSwNP who demonstrate sinus colonization with staphylococcus aureus, the administration of dupilumab will be associated with decreased staph colonization and an increase in microbial diversity.\n\nPrimary Objective will be to demonstrate that dupilumab reduces staphylococcus aureus (phyla firmicutes) abundance while increasing microbial diversity in patients with CRSwNPs who are culture positive for staph aureus at enrollment.\n\nSecondary Objectives will be to correlate reduction in Staph aureus abundance and improved bacterial diversity with increased expression of anti-microbial proteins (ß-defensins1-4) and cathelicidin LL-37. In addition, the investigators will correlate improvements in microbial diversity\u002Fdecreased staph abundance with clinical improvements as assessed via questionnaires and objective\u002Fsubjective smell function and also as improvements in cellular\u002Fimmune T2 inflammation as assessed by reduced expression of T2 cytokines\u002Fchemokines and eosinophil\u002Feosinophil-derived proteins.",[81,82],"Nasal Polyps","Staphylococcus Aureus",[84,85,86],"Nasal polyps","Staph aureus","Interleukin-4\u002F-13","2025-03-26",{"date":89,"type":90},"2025-04-01","ACTUAL",{"date":92,"type":90},"2022-09-01",{"date":94,"type":75},"2026-12-31",{"name":5,"class":6},1]