[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100655720":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":39,"studyPopulation":20,"armGroups":40,"interventions":58,"overallOfficials":20,"centralContacts":20,"locations":73,"responsibleParty":171,"collaborators":20,"id":173,"slug":174,"hasResults":175,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":179,"eligibilityCriteria":180,"healthyVolunteers":175,"sex":181,"minAge":182,"maxAge":183,"enrollmentInfo":184,"targetDuration":20,"studyType":187,"phases":188,"briefSummary":190,"conditions":191,"keywords":193,"overallStatus":76,"whyStopped":20,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":206},{"fullName":5,"class":6},"Instituto de Investigación Marqués de Valdecilla","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":20},[9],{"measure":10,"description":11,"timeFrame":12},"the efficacy of mepolizumab+polypectomy compared to mepolizumab or polypectomy, using the change from baseline in sinonasal outcome test (SNOT-22) total score at week 52.","SNOT-22 total score ranges from 0 to 110, with higher scores indicating worse quality of life\u002Fmore severe symptoms.","12 moths",[14,18,21,23,26,30],{"measure":15,"description":16,"timeFrame":17},"Change in nasal polyposis severity VAS score at V1, V6, V12.","VAS score ranges from 0 to 100, with higher scores indicating greater symptom severity.","1 month, 6 months and 12 months",{"measure":19,"description":20,"timeFrame":17},"Change in endoscopic nasal polyp score at V1, V6, V12",null,{"measure":22,"description":20,"timeFrame":17},"Improvement in individual VAS symptoms (rhinorrhea, mucus in throat, nasal blockage, and sense of smell), patient-reported outcomes at V1, V6, V12",{"measure":24,"description":20,"timeFrame":25},"Number of patients no longer requiring rescue systemic corticosteroid treatment throughout the first year after the first month of starting the study","12 months",{"measure":27,"description":28,"timeFrame":29},"Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) Related to Mepolizumab and\u002For In-office Nasal Polypectomy","Adverse events collected at each study visit and classified as serious or non-serious per protocol definitions, and by causal relationship to treatment (unrelated, possible, probable) as assessed by the investigator.","1 month, 2 months, 4 months, 6 months, 8 months, 10 months and 12 months",{"measure":31,"description":20,"timeFrame":32},"Change from baseline in sinonasal outcome test (SNOT-22) total score at weeks 4 and 24","1 month and 12 months",{"allocation":34,"interventionModel":35,"interventionModelDescription":20,"primaryPurpose":36,"observationalModel":20,"timePerspective":20,"maskingInfo":37},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":38,"maskingDescription":20,"whoMasked":20},"NONE","Patients with chronic rhinosinusitis with nasal polyps (CRSwNP) and indication for biologic treatment according to the criteria of the EPOS2020 guideline.\n\nPresence of bilateral polyps in a patient who had endoscopic sinus surgery (ESS) (except in cases where the patient is not fit for surgery) and three of the following criteria are required:\n\n1. Evidence of type 2 inflammation (tissue eos\\> 10\u002Fhpf\\* or blood eos\\>250, OR total IgE\\> 100).\n\n   \\* Whenever possible histology from previous surgery should be reviewed to confirm if eosinophilic pathology. If the previous surgery was performed more than 2 years earlier, a blood eosinophil count is essential, as the previous biopsy data may not be relevant.\n2. Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (\\>3 months)\n3. Significantly impaired quality of life (SNOT ≥ 40)\n4. Significant loss of smell (VAS).\n5. Diagnosis of comorbid asthma",[41,47,53],{"label":42,"type":43,"description":44,"interventionNames":45},"surgical arm","ACTIVE_COMPARATOR","This group of patients will undergo nasal polypectomy in the office and will not receive mepolizumab treatment.",[46],"Procedure: surgical arm",{"label":48,"type":49,"description":50,"interventionNames":51},"medical arm","EXPERIMENTAL","This group of patients will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.",[52],"Drug: Mepolizumab 100 MG",{"label":54,"type":49,"description":55,"interventionNames":56},"combined arm","This group of patients will undergo in-office nasal polypectomy before starting treatment with mepolizumab. Mepolizumab treatment will be administered at the surgical procedure visit or within 48 hours after the polypectomy.",[57],"Other: combined arm",[59,63,68],{"type":60,"name":42,"description":61,"armGroupLabels":62,"otherNames":20},"PROCEDURE","polypectomy in the office and will not receive mepolizumab treatment.",[42],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":20},"DRUG","Mepolizumab 100 MG","will not undergo in-office nasal polypectomy and will start treatment with mepolizumab directly after randomization.",[48],{"type":6,"name":54,"description":69,"armGroupLabels":70,"otherNames":71},"in-office nasal polypectomy before starting treatment with mepolizumab. Mepolizumab treatment will be administered at the surgical procedure visit or within 48 hours after the polypectomy.",[54],[72],"polypeptomy + mepolizumab",[74,92,105,118,131,145,158],{"facility":75,"status":76,"city":77,"state":20,"zip":20,"country":78,"countryCode":79,"cosmosGeoPoint":80,"geoPoint":85,"contacts":86},"Hospital de Cruces","RECRUITING","Barakaldo","Spain","ES",{"type":81,"coordinates":82},"Point",[83,84],-2.98813,43.29639,{"lat":84,"lon":83},[87],{"name":88,"role":89,"phone":90,"phoneExt":20,"email":91},"Francisco Valcarcel","CONTACT","+34946006000","patxivalcarcel@gmail.com",{"facility":93,"status":76,"city":94,"state":20,"zip":20,"country":78,"countryCode":79,"cosmosGeoPoint":95,"geoPoint":99,"contacts":100},"Hospital de Jerez","Jerez de la Frontera",{"type":81,"coordinates":96},[97,98],-6.13606,36.68645,{"lat":98,"lon":97},[101],{"name":102,"role":89,"phone":103,"phoneExt":20,"email":104},"Alfonso del cuvillo Bernal","+34956032000","dr.cuvillo@comcadiz.es",{"facility":106,"status":76,"city":107,"state":20,"zip":20,"country":78,"countryCode":79,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Hospital Puerta del Hierro","Madrid",{"type":81,"coordinates":109},[110,111],-3.70256,40.4165,{"lat":111,"lon":110},[114],{"name":115,"role":89,"phone":116,"phoneExt":20,"email":117},"Antonio Martinez","+34911916000","amruizcoello@gmail.com",{"facility":119,"status":76,"city":120,"state":20,"zip":20,"country":78,"countryCode":79,"cosmosGeoPoint":121,"geoPoint":125,"contacts":126},"Hospital de Salamanca","Salamanca",{"type":81,"coordinates":122},[123,124],-3.67975,40.42972,{"lat":124,"lon":123},[127],{"name":128,"role":89,"phone":129,"phoneExt":20,"email":130},"Maria gil","+34923291100","mgilmel@saludcastillayleon.es",{"facility":132,"status":76,"city":133,"state":20,"zip":134,"country":78,"countryCode":79,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Hospital universitario Marques de Valdecilla","Santander","39006",{"type":81,"coordinates":136},[137,138],-3.80493,43.46589,{"lat":138,"lon":137},[141],{"name":142,"role":89,"phone":143,"phoneExt":20,"email":144},"david lobo duro","+34942315515","david.lobo@scsalud.es",{"facility":146,"status":76,"city":147,"state":20,"zip":20,"country":78,"countryCode":79,"cosmosGeoPoint":148,"geoPoint":152,"contacts":153},"Hospital Universitario Virgen Macarena","Seville",{"type":81,"coordinates":149},[150,151],-5.97317,37.38283,{"lat":151,"lon":150},[154],{"name":155,"role":89,"phone":156,"phoneExt":20,"email":157},"Serafín Sánchez Gómez","+34955008000","serafin.sanchez.sspa@juntadeandalucia.es",{"facility":159,"status":76,"city":160,"state":20,"zip":20,"country":78,"countryCode":79,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Hospital de Valladolid","Valladolid",{"type":81,"coordinates":162},[163,164],-4.72353,41.65541,{"lat":164,"lon":163},[167],{"name":168,"role":89,"phone":169,"phoneExt":20,"email":170},"Jaime Santos","+34983420000","jsp002@gmail.com",{"type":172,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100655720","phase-4-mepolizumab-and-in-office-office-nasal-polypectomy-in-patients-with-chronic-rhinosinusitis-crs-100655720",false,"NCT07814924","Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS).","Mepolizumab and in Office-office Nasal Polypectomy in Patients With Chronic Rhinosinusitis (CRS). A Three Arm Study.","MELYSA","Inclusion Criteria:\n\n1. Participant 18 years of age or older\n2. Patients with a diagnosis of CRS with polyposis according to the criteria of the EPOS2020 guideline:\n\n   Chronic rhinosinusitis with nasal polyps in adults is defined as presence of two or more symptoms, one of which should be either nasal blockage \u002F obstruction \u002F congestion or nasal discharge (anterior \u002F posterior nasal drip); ± facial pain\u002Fpressure; ± reduction or loss of smell; for ≥12 weeks; and either endoscopic signs of nasal polyps, and\u002For CT changes: mucosal changes within the ostiomeatal complex and\u002For sinuses.\n3. Patients with indication for biologic treatment according to the criteria of the EPOS2020 guideline. Presence of bilateral polyps in a patient who had ESS and three of the following criteria are required:\n\n   3.1. Evidence of type 2 inflammation (tissue eos\\> 10\u002Fhpf\\* or blood eos\\>250, OR total IgE\\> 100).\n\n   \\* Whenever possible histology from previous surgery should be reviewed to confirm if eosinophilic pathology. If the previous surgery was performed more than 2 years earlier, a blood eosinophil count is essential, as the previous biopsy data may not be relevant.\n\n   3.2. Need for systemic corticosteroids or contraindication to systemic steroids (≥ 2 courses per yr, OR long term (\\>3 months)\n\n   3.3. Significantly impaired quality of life (SNOT ≥ 40)\n\n   3.4. Significant loss of smell (≥7 VAS)\n\n   3.5. Diagnosis of comorbid asthma\n4. Basal eosinophil count (BEC) ≥300 cells\u002FµL for surgical naïve patients- or for those who have had surgery and have recurrence . The result of a previous analysis would be valid if it was obtained in a period of time not exceeding one year\n5. Patients have been informed and signed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Any serious or uncontrolled systemic or psychiatric illness that prevents a correct cognitive or endoscopic assessment or does not advise participation in the study.\n2. Unilateral localized secondary CRS (odontogenic, fungal ball, tumor).\n3. Bilateral diffuse secondary CRS (cystic fibrosis; eosinophilic granulomatosis with polyangiitis-S. de Churg-Strauss-; granulomatosis with polyangiitis-S de Wegener-; primary ciliary dyskinesia; selective immunodeficiencies.\n4. Pregnancy\u002F breast feeding.\n5. Hypersensitivity to mepolizumab or its excipients.\n6. Patients unable to complete the questionnaire or follow prescribed treatment.\n7. Patients who are participating in another clinical trial related to polyposis or asthma.\n8. Previously documented failure with IL-5\u002FIL-5 receptor biologics","ALL","18 Years","80 Years",{"count":185,"type":186},75,"ESTIMATED","INTERVENTIONAL",[189],"PHASE4","This randomized, controlled multicenter trial will recruit patients aged 18 to 70 years with recurrent nasal polyposis requiring surgery and indication for biologic treatment according to EPOS 2020 guideline. Patients in the Mepolizumab arms will receive 100 mg of subcutaneous mepolizumab every 4 weeks for a total of 12 doses in addition to daily topical corticosteroid treatment.\n\nAll study procedures will be performed in five study visits and may take approximately 30 minutes. Clinical assessments include ifferent questionnaires and nasal endoscopy. This trial includes three treatment arms.\n\n1. Combined group (In-office nasal polypectomy group with mepolizumab): This group will undergone in-office nasal polypectomy and will receive Mepolizumab.\n2. Medical group (mepolizumab): This group will receive Mepolizumab.\n3. Surgical group (In-office nasal polypectomy): This group will undergone in-office nasal polypectomy. The main advantage is that it allows comparison of mepolizumab versus surgery and surgery\u002Fmepolizumab versus surgery + mepolizumab, providing more information on the most effective therapeutic approach.\n\nThe presence of adverse effects will be assessed in each treatment arm.",[192],"Chronic Rhinosinusitis With Nasal Polyps",[194,195,196],"mepolizumab","polypeptomy","in office nasal","2026-09-10",{"date":199,"type":200},"2026-09-11","ACTUAL",{"date":202,"type":200},"2024-12-31",{"date":204,"type":186},"2026-12-31",{"name":5,"class":6},7]