[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607363":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":181,"collaborators":12,"id":184,"slug":12,"hasResults":185,"nctId":186,"briefTitle":187,"officialTitle":187,"acronym":12,"eligibilityCriteria":188,"healthyVolunteers":185,"sex":189,"minAge":190,"maxAge":12,"enrollmentInfo":191,"targetDuration":12,"studyType":194,"phases":195,"briefSummary":197,"conditions":198,"keywords":12,"overallStatus":73,"whyStopped":12,"lastUpdateSubmitDate":200,"lastUpdatePostDateStruct":201,"startDateStruct":204,"completionDateStruct":206,"leadSponsor":208,"locationsCount":209},{"fullName":5,"class":6},"Rigshospitalet, Denmark","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"Standard dosing of biological therapy","NO_INTERVENTION","Continues dosing of mepolizumab (100 mg via injection pen, subcutaneous injection) or dupilumab (300 mg via injection pen, subcutaneous injection) every 4 weeks.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Increased dosing interval of biological therapy","ACTIVE_COMPARATOR","Increases to a 6-week dosing interval at baseline - of mepolizumab (100 mg via injection pen, subcutaneous injection) or dupilumab (300 mg via injection pen, subcutaneous injection) - and if response to therapy is maintained, increases to 8-week dosing intervals at the follow-up visit in week 26. Thereafter, dosing every 8 weeks is maintained until the patient completes the trial at week 52.",[18],"Drug: increased dosing interval of biological therapy",[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":12},"DRUG","increased dosing interval of biological therapy","Increasing dosing interval of biological therapy for CRSwNP from every 4 weeks to every 6 weeks and if continued satisfactory response then to every 8 weeks.",[14],[26],{"name":27,"affiliation":28,"role":29},"Christian von Buchwald, MD, DMSc, prof.","Rigshospitalet, Dept. of Otorhinolaryngology, Head and Neck Surgery & Audiology","STUDY_DIRECTOR",[31],{"name":32,"role":33,"phone":34,"phoneExt":12,"email":35},"Elizabeth M. Stevens Saporito, MD","CONTACT","+4535452370","este0027@regionh.dk",[37,56,71,90,105,120,135,150,166],{"facility":38,"status":39,"city":40,"state":12,"zip":41,"country":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"Dept of otorhinolaryngology, Aalborg University Hospital","NOT_YET_RECRUITING","Aalborg","9000","Denmark",{"type":44,"coordinates":45},"Point",[46,47],9.9187,57.048,{"lat":47,"lon":46},[50,54],{"name":51,"role":33,"phone":52,"phoneExt":12,"email":53},"Søren Pauli, MD","004597660000","sbro@rn.dk",{"name":51,"role":55,"phone":12,"phoneExt":12,"email":12},"PRINCIPAL_INVESTIGATOR",{"facility":57,"status":39,"city":58,"state":12,"zip":59,"country":42,"cosmosGeoPoint":60,"geoPoint":64,"contacts":65},"Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital","Aarhus","8200",{"type":44,"coordinates":61},[62,63],10.21076,56.15674,{"lat":63,"lon":62},[66,70],{"name":67,"role":33,"phone":68,"phoneExt":12,"email":69},"Kristian B Petersen, MD","004578450000","krispete@rm.dk",{"name":67,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":72,"status":73,"city":74,"state":12,"zip":75,"country":42,"cosmosGeoPoint":76,"geoPoint":80,"contacts":81},"Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet","RECRUITING","Copenhagen","2100",{"type":44,"coordinates":77},[78,79],12.56553,55.67594,{"lat":79,"lon":78},[82,85,86,87],{"name":83,"role":33,"phone":34,"phoneExt":12,"email":84},"Christian M. von Buchwald, MD, DMSc, prof.","christian.von.buchwald@regionh.dk",{"name":12,"role":33,"phone":12,"phoneExt":12,"email":84},{"name":27,"role":55,"phone":12,"phoneExt":12,"email":12},{"name":88,"role":89,"phone":12,"phoneExt":12,"email":12},"Elizabeth M. Stevens, MD","SUB_INVESTIGATOR",{"facility":91,"status":39,"city":92,"state":12,"zip":93,"country":42,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Esbjerg Og Grindsted Sygehus","Esbjerg","6700",{"type":44,"coordinates":95},[96,97],8.45187,55.47028,{"lat":97,"lon":96},[100,104],{"name":101,"role":33,"phone":102,"phoneExt":12,"email":103},"Jonas H Andersen, MD","004579182774","jonas.hjelm.andersen2@rsyd.dk",{"name":101,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":106,"status":39,"city":107,"state":12,"zip":108,"country":42,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Dept of otorhinolaryngology, Gødstrup Regional Hospital","Herning","7400",{"type":44,"coordinates":110},[111,112],8.97662,56.13615,{"lat":112,"lon":111},[115,119],{"name":116,"role":33,"phone":117,"phoneExt":12,"email":118},"Adnan Madzak, MD","004578439744","adnan.madzak@auh.rm.dk",{"name":116,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":121,"status":73,"city":122,"state":12,"zip":123,"country":42,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Dept of otorhinolaryngology, Nordsjaellands Hospital","Hillerød","3400",{"type":44,"coordinates":125},[126,127],12.30081,55.92791,{"lat":127,"lon":126},[130,134],{"name":131,"role":33,"phone":132,"phoneExt":12,"email":133},"Grethe B Samuelsen, MD, PhD","004548293825","grethe.badsberg.samuelsen@regionh.dk",{"name":131,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":136,"status":73,"city":137,"state":12,"zip":138,"country":42,"cosmosGeoPoint":139,"geoPoint":143,"contacts":144},"Dept of otorhinolaryngology, Sjællands Universitetshospital","Køge","4600",{"type":44,"coordinates":140},[141,142],12.18214,55.45802,{"lat":142,"lon":141},[145,149],{"name":146,"role":33,"phone":147,"phoneExt":12,"email":148},"Bent Ivan Larsen, MD","004547321401","bele@regionsjaelland.dk",{"name":146,"role":55,"phone":12,"phoneExt":12,"email":12},{"facility":151,"status":39,"city":152,"state":12,"zip":153,"country":42,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Dept of otorhinolaryngology, Odense University Hospital","Odense","5000",{"type":44,"coordinates":155},[156,157],10.38831,55.39594,{"lat":157,"lon":156},[160,164],{"name":161,"role":33,"phone":162,"phoneExt":12,"email":163},"Anette Kjeldsen, MD, prof.","004565414314","anette.kjeldsen@rsyd.dk",{"name":165,"role":55,"phone":12,"phoneExt":12,"email":12},"Anette Kjeldsen, MD, prof",{"facility":167,"status":39,"city":168,"state":12,"zip":169,"country":42,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Dept of otorhinolaryngology, Lillebaelt Hospital","Vejle","7100",{"type":44,"coordinates":171},[172,173],9.5357,55.70927,{"lat":173,"lon":172},[176,180],{"name":177,"role":33,"phone":178,"phoneExt":12,"email":179},"Lars Christian Meyer, MD","004579405000","lars.christian.meyer@rsyd.dk",{"name":177,"role":55,"phone":12,"phoneExt":12,"email":12},{"type":55,"investigatorFullName":182,"investigatorTitle":183,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Elizabeth M. Stevens","national coordinating investigator, and sub-investigator at Rigshospitalet","100607363",false,"NCT07187583","Tapering of Biologics in Chronic Rhinosinusitis With Nasal Polyps","Inclusion Criteria:\n\n* ≥18 years of age.\n* Currently receiving treatment with either dupilumab (300 mg) or mepolizumab (100 mg) every four weeks.\n* Having received the biologic at unchanged dosing interval for at least three months.\n* For at least one year during treatment with biologics, the patients' CRSwNP must be categorized as \"partly controlled\" as defined by presence of 1-2 of the following seven items (also available in EPOS 2020 table in protocol):\n\n  1. Nasal blockage: present on most days of the week\n  2. Rhinorrhoea\u002Fpostnasal drip: mucopurulent on most days of the week\n  3. Facial pain\u002Fpressure: present on most days of the week\n  4. Sense of smell: impaired\n  5. Sleep disturbance or fatigue: present\n  6. Nasal endoscopy: diseased mucosa\n  7. Rescue treatment (systemic corticosteroids, ESS, antibiotics): need of 1 course of rescue treatment\n\nof which 1-5 will be scored by the patient using VAS (0-10) and noted above 5.\n\nExclusion Criteria:\n\n* Patients with excellent response to biologics (0 of the above-mentioned 7 items for partly controlled disease)\n* Patients with no or limited response to biologics (\\>2 of the above-mentioned 7 items for partly controlled disease)\n* Patients with a cancer diagnosis deemed by the investigator to preclude participation in the trial\n* Patients who, because of language barriers, are not able to understand Danish written information and, thus, are not able to answer questionnaires\n* Patients who currently receive biologics for any other disease (asthma not included)\n* Patients who are not able to give informed consent (i.e., patients who are permanently incapable)\n* Patients who are not eligible because of the investigator's judgement\n* Patients who experience pregnancy during the study will be excluded after an unscheduled visit - active IVF treatment (please see below)\n* Unwillingness to follow the study procedure","ALL","18 Years",{"count":192,"type":193},135,"ESTIMATED","INTERVENTIONAL",[196],"PHASE4","The purpose of this study is to investigate the feasibility of extending the dosing intervals of biological therapies while maintaining optimal treatment effects in chronic rhinosinusitis with nasal polyps (CRSwNP).",[199],"Chronic Rhinosinusitis With Nasal Polyps","2025-09-18",{"date":202,"type":203},"2025-09-23","ACTUAL",{"date":205,"type":203},"2025-06-05",{"date":207,"type":193},"2028-03-01",{"name":5,"class":6},9]