[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613723":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":44,"responsibleParty":58,"collaborators":26,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":26,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":26,"enrollmentInfo":69,"targetDuration":26,"studyType":72,"phases":73,"briefSummary":76,"conditions":77,"keywords":79,"overallStatus":84,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Washington University School of Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"nebulizer group","EXPERIMENTAL","Subjects in the nebulizer group will be prescribed a 42-day supply of 0.5 mg budesonide packets, to be used twice daily without any concomitant saline lavage.",[13],"Combination Product: nebulized budesonide via NasoNeb",{"label":15,"type":16,"description":17,"interventionNames":18},"budesonide lavage group","ACTIVE_COMPARATOR","Subjects in the budesonide lavage group will be prescribed 42-day supply of 0.5 mg budesonide packets to be administered via 240 mL twice daily nasal saline lavage.",[19],"Combination Product: budesonide lavage via NeilMed",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"COMBINATION_PRODUCT","nebulized budesonide via NasoNeb","For the nebulization group, each dose will be dissolved in 10 mL saline with 5 mL nebulized solution being applied to each nasal cavity.\n\nDevice: NasoNeb",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"budesonide lavage via NeilMed","For the lavage group, each dose will be dissolved in 240 mL saline and 120 mL of the solution will be administered to each nasal cavity.\n\nDevice: NeilMed",[15],[32],{"name":33,"affiliation":5,"role":34},"Nyssa Farrell, MD","PRINCIPAL_INVESTIGATOR",[36,40],{"name":33,"role":37,"phone":38,"phoneExt":26,"email":39},"CONTACT","314-362-7509","nyssa.farrell@wustl.edu",{"name":41,"role":37,"phone":42,"phoneExt":26,"email":43},"Sara Kukuljan","314-362-7563","kukuljas@wustl.edu",[45],{"facility":46,"status":26,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":26},"Nyssa Fox Farrell","St Louis","Missouri","63122","United States","US",{"type":53,"coordinates":54},"Point",[55,56],-90.19789,38.62727,{"lat":56,"lon":55},{"type":59,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100613723","phase-1-nebulized-nasal-steroids-100613723",false,"NCT07270302","Nebulized Nasal Steroids","Safety and Efficacy of Nebulized Nasal Steroids for the Treatment of Chronic Rhinosinusitis","Inclusion Criteria:\n\n* Age 18 or older that meet diagnostic criteria for CRS with or without polyposis as documented by their recruiting physician.\n* Diagnostic criteria for CRS will be defined according to EPOS criteria of \\>12 weeks of 2 of the following subjective symptoms: nasal blockage or obstruction, rhinorrhea, hyposmia, or facial pain\u002Fpressure AND objective evidence of CRS on either nasal endoscopy or CT scan\n\nExclusion Criteria:\n\n* Patients who have previously undergone sinus surgery\n* Severe polyposis; defined as Lund Kennedy endoscopy score greater than 1\n* Patients who are currently using or who have previously used biologic medications for their nasal polyps. These medications include: dupilumab, omalizumab, mepolizumab, tezepelumab, or depemokimab\n* Inability to complete surveys in English\n* known comorbid mucociliary disease\n* known adrenal disease or other HPA dysfunction\n* patients taking oral corticosteroids for other medical conditions\n* oral antibiotic administration within 2 weeks of study participation\n* a baseline SNOT-22 score less than 9, due to inability to achieve the MCID","ALL","18 Years",{"count":70,"type":71},50,"ESTIMATED","INTERVENTIONAL",[74,75],"PHASE1","PHASE2","The goal of the proposed project is to assess the efficacy, safety, and patient experience of budesonide administered via the NasoNeb system for medical management of CRS. The authors propose a randomized controlled trial of nebulized budesonide via the NasoNeb compared against budesonide lavage.",[78],"Chronic Rhinosinusitis",[80,81,82,83],"Otolaryngology","Pharmacology","Pharmacy","intranasal steroid sprays","NOT_YET_RECRUITING","2025-11-26",{"date":87,"type":88},"2025-12-08","ACTUAL",{"date":90,"type":71},"2025-12",{"date":92,"type":71},"2026-05",{"name":5,"class":6},1]