[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100622688":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":11,"centralContacts":29,"locations":35,"responsibleParty":51,"collaborators":11,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":11,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":74,"overallStatus":79,"whyStopped":11,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Peking University Third Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Nasal Drops Group","EXPERIMENTAL",null,[13],"Device: Nasal Drops",{"label":15,"type":16,"description":11,"interventionNames":17},"Standard Nasal Spray Group","ACTIVE_COMPARATOR",[18],"Device: Nasal Spray",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DEVICE","Nasal Drops","Patients will assume the Mygind position (supine with head extended over the edge of the bed, nostrils facing upward). Five drops of budesonide suspension (2ml:1mg) will be administered into each nostril to ensure delivery to the olfactory cleft at the nasal apex. The position will be maintained for approximately 5 minutes, after which any residual medication in the oral or nasal cavity may be expelled. This procedure will be performed twice daily (morning and evening) for 3 months. During the first month, olfactory function will be assessed weekly, with a nasal sinus CT scan at the end of the month. In the second month, olfactory evaluations will be conducted biweekly, followed by a final assessment at the end of the third month.",[9],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Nasal Spray","Patients will use budesonide nasal spray administered in the same Mygind position, with 2 sprays per nostril (total daily dose: 200μg). After administration, patients will gently sniff to facilitate drug dispersion. The treatment duration and follow-up schedule will be identical to the experimental group.",[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},"Dawei Wu, MD, PhD","CONTACT","13522503401","davidwuorl@163.com",[36],{"facility":37,"status":11,"city":38,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Dawei Wu","Beijing","Beijing Municipality","100191","China","CN",{"type":44,"coordinates":45},"Point",[46,47],116.39723,39.9075,{"lat":47,"lon":46},[50],{"name":31,"role":32,"phone":33,"phoneExt":11,"email":34},{"type":52,"investigatorFullName":37,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Associate Researcher","100622688","the-efficacy-of-olfactory-cleft-steroid-drops-in-patients-with-crs-with-olfactory-cleft-obstruction-100622688",false,"NCT07386873","The Efficacy of Olfactory Cleft Steroid Drops in Patients With CRS With Olfactory Cleft Obstruction","Randomized Controlled Trial on the Efficacy of Olfactory Cleft Steroid Drops in Patients With Chronic Rhinosinusitis With Olfactory Cleft Obstruction","Inclusion Criteria:\n\n1. Prospective enrollment of otolaryngology clinic patients aged 18-65 years with olfactory dysfunction. Diagnosis of chronic rhinosinusitis-related olfactory dysfunction is based on the EPOS 2020 guidelines. Participants must demonstrate olfactory impairment via Sniffin' Sticks testing, with TDI scores (sum of Threshold, Discrimination, and Identification) meeting:(1) Hyposmia: 16 \\\u003C TDI \\\u003C 30.75; (2) 3.Anosmia: TDI \\\u003C 15.\n2. Sinus CT scans confirming obstruction in the olfactory cleft region.\n3. Willingness to participate and signed informed consent.\n\nExclusion Criteria:\n\n1. Use of systemic corticosteroids within 4 weeks or intranasal steroids within 2 weeks prior to enrollment.\n2. Severe nasal septum deviation, nasal tumors, acute upper respiratory infections, or uncontrolled allergic rhinitis.\n3. Severe cardiovascular disease, hepatic\u002Frenal insufficiency, uncontrolled diabetes, or immune system disorders.\n4. Current or planned pregnancy.\n5. Investigator-determined inability to comply with study requirements (e.g., memory\u002Fbehavioral disorders, depression, heavy alcohol use, prior non-compliance).","ALL","18 Years","65 Years",{"count":65,"type":66},54,"ESTIMATED","INTERVENTIONAL",[69],"NA","This study aims to compare the efficacy of steroid nasal drops targeting the olfactory cleft versus traditional intranasal steroid sprays in improving olfactory function in patients with chronic rhinosinusitis (CRS) with olfactory cleft obstruction. The main questions this clinical trial aims to answer are:\n\n1. Efficacy Comparison: Is olfactory improvement greater with olfactory cleft-targeted steroid nasal drops compared to standard nasal steroid sprays in CRS patients?\n2. Mechanism Exploration: How do changes in inflammatory markers, obstruction severity, and olfactory test results explain the potential benefits of this treatment approach?",[72,73],"Chronic Rhinosinusitis (CRS)","Smell Dysfunction",[75,76,77,78],"Olfactory dysfunction","Chronic rhinosinusitis","Steroid nasal drops","Olfactory cleft obstruction","NOT_YET_RECRUITING","2026-02-02",{"date":82,"type":83},"2026-02-04","ACTUAL",{"date":85,"type":66},"2026-03-01",{"date":87,"type":66},"2028-12-31",{"name":5,"class":6},1]