[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607363":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":182,"collaborators":12,"id":185,"slug":186,"hasResults":187,"nctId":188,"briefTitle":189,"officialTitle":189,"acronym":12,"eligibilityCriteria":190,"healthyVolunteers":187,"sex":191,"minAge":192,"maxAge":12,"enrollmentInfo":193,"targetDuration":12,"studyType":196,"phases":197,"briefSummary":199,"conditions":200,"keywords":12,"overallStatus":74,"whyStopped":12,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":211},{"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",[37,57,72,91,106,121,136,151,167],{"facility":38,"status":39,"city":40,"state":12,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Dept of otorhinolaryngology, Aalborg University Hospital","NOT_YET_RECRUITING","Aalborg","9000","Denmark","DK",{"type":45,"coordinates":46},"Point",[47,48],9.9187,57.048,{"lat":48,"lon":47},[51,55],{"name":52,"role":33,"phone":53,"phoneExt":12,"email":54},"Søren Pauli, MD","004597660000","sbro@rn.dk",{"name":52,"role":56,"phone":12,"phoneExt":12,"email":12},"PRINCIPAL_INVESTIGATOR",{"facility":58,"status":39,"city":59,"state":12,"zip":60,"country":42,"countryCode":43,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Dept of otorhinolaryngology, head and neck surgery, Aarhus University Hospital","Aarhus","8200",{"type":45,"coordinates":62},[63,64],10.21076,56.15674,{"lat":64,"lon":63},[67,71],{"name":68,"role":33,"phone":69,"phoneExt":12,"email":70},"Kristian B Petersen, MD","004578450000","krispete@rm.dk",{"name":68,"role":56,"phone":12,"phoneExt":12,"email":12},{"facility":73,"status":74,"city":75,"state":12,"zip":76,"country":42,"countryCode":43,"cosmosGeoPoint":77,"geoPoint":81,"contacts":82},"Department of Otorhinolaryngology, Head and Neck Surgery & Audiology, Copenhagen University, Rigshospitalet","RECRUITING","Copenhagen","2100",{"type":45,"coordinates":78},[79,80],12.56553,55.67594,{"lat":80,"lon":79},[83,86,87,88],{"name":84,"role":33,"phone":34,"phoneExt":12,"email":85},"Christian M. von Buchwald, MD, DMSc, prof.","christian.von.buchwald@regionh.dk",{"name":12,"role":33,"phone":12,"phoneExt":12,"email":85},{"name":27,"role":56,"phone":12,"phoneExt":12,"email":12},{"name":89,"role":90,"phone":12,"phoneExt":12,"email":12},"Elizabeth M. Stevens, MD","SUB_INVESTIGATOR",{"facility":92,"status":39,"city":93,"state":12,"zip":94,"country":42,"countryCode":43,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Esbjerg Og Grindsted Sygehus","Esbjerg","6700",{"type":45,"coordinates":96},[97,98],8.45187,55.47028,{"lat":98,"lon":97},[101,105],{"name":102,"role":33,"phone":103,"phoneExt":12,"email":104},"Jonas H Andersen, MD","004579182774","jonas.hjelm.andersen2@rsyd.dk",{"name":102,"role":56,"phone":12,"phoneExt":12,"email":12},{"facility":107,"status":39,"city":108,"state":12,"zip":109,"country":42,"countryCode":43,"cosmosGeoPoint":110,"geoPoint":114,"contacts":115},"Dept of otorhinolaryngology, Gødstrup Regional Hospital","Herning","7400",{"type":45,"coordinates":111},[112,113],8.97662,56.13615,{"lat":113,"lon":112},[116,120],{"name":117,"role":33,"phone":118,"phoneExt":12,"email":119},"Adnan Madzak, MD","004578439744","adnan.madzak@auh.rm.dk",{"name":117,"role":56,"phone":12,"phoneExt":12,"email":12},{"facility":122,"status":74,"city":123,"state":12,"zip":124,"country":42,"countryCode":43,"cosmosGeoPoint":125,"geoPoint":129,"contacts":130},"Dept of otorhinolaryngology, Nordsjaellands Hospital","Hillerød","3400",{"type":45,"coordinates":126},[127,128],12.30081,55.92791,{"lat":128,"lon":127},[131,135],{"name":132,"role":33,"phone":133,"phoneExt":12,"email":134},"Grethe B Samuelsen, MD, PhD","004548293825","grethe.badsberg.samuelsen@regionh.dk",{"name":132,"role":56,"phone":12,"phoneExt":12,"email":12},{"facility":137,"status":74,"city":138,"state":12,"zip":139,"country":42,"countryCode":43,"cosmosGeoPoint":140,"geoPoint":144,"contacts":145},"Dept of otorhinolaryngology, Sjællands Universitetshospital","Køge","4600",{"type":45,"coordinates":141},[142,143],12.18214,55.45802,{"lat":143,"lon":142},[146,150],{"name":147,"role":33,"phone":148,"phoneExt":12,"email":149},"Bent Ivan Larsen, MD","004547321401","bele@regionsjaelland.dk",{"name":147,"role":56,"phone":12,"phoneExt":12,"email":12},{"facility":152,"status":39,"city":153,"state":12,"zip":154,"country":42,"countryCode":43,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Dept of otorhinolaryngology, Odense University Hospital","Odense","5000",{"type":45,"coordinates":156},[157,158],10.38831,55.39594,{"lat":158,"lon":157},[161,165],{"name":162,"role":33,"phone":163,"phoneExt":12,"email":164},"Anette Kjeldsen, MD, prof.","004565414314","anette.kjeldsen@rsyd.dk",{"name":166,"role":56,"phone":12,"phoneExt":12,"email":12},"Anette Kjeldsen, MD, prof",{"facility":168,"status":39,"city":169,"state":12,"zip":170,"country":42,"countryCode":43,"cosmosGeoPoint":171,"geoPoint":175,"contacts":176},"Dept of otorhinolaryngology, Lillebaelt Hospital","Vejle","7100",{"type":45,"coordinates":172},[173,174],9.5357,55.70927,{"lat":174,"lon":173},[177,181],{"name":178,"role":33,"phone":179,"phoneExt":12,"email":180},"Lars Christian Meyer, MD","004579405000","lars.christian.meyer@rsyd.dk",{"name":178,"role":56,"phone":12,"phoneExt":12,"email":12},{"type":56,"investigatorFullName":183,"investigatorTitle":184,"investigatorAffiliation":5,"oldNameTitle":12,"oldOrganization":12},"Elizabeth M. Stevens","national coordinating investigator, and sub-investigator at Rigshospitalet","100607363","phase-4-tapering-of-biologics-in-chronic-rhinosinusitis-with-nasal-polyps-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":194,"type":195},135,"ESTIMATED","INTERVENTIONAL",[198],"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).",[201],"Chronic Rhinosinusitis With Nasal Polyps","2025-09-18",{"date":204,"type":205},"2025-09-23","ACTUAL",{"date":207,"type":205},"2025-06-05",{"date":209,"type":195},"2028-03-01",{"name":5,"class":6},9]