[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558833":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":30,"responsibleParty":44,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":30,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":30,"enrollmentInfo":61,"targetDuration":30,"studyType":64,"phases":65,"briefSummary":67,"conditions":68,"keywords":30,"overallStatus":71,"whyStopped":30,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":30},{"fullName":5,"class":6},"St. Paul's Sinus Centre","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Dupilumab","ACTIVE_COMPARATOR","30 subjects undergoing ESS + dupilumab 300 (1-week post-surgery) every 2 weeks + standard of care treatment (INCS + background asthma medication) for 24 weeks",[13],"Drug: Dupilumab",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","30 subjects undergoing ESS + placebo (1-week post-surgery) every 2 weeks + standard of care treatment (INCS + background asthma medication) for 24 weeks.",[19],"Other: Placebo",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Dupilumab 300mg every 2 weeks for 24 weeks",[9],[26],"dupixent",{"type":6,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"Placebo 300mg every 2 weeks for 24 weeks",[15],null,[32],{"name":33,"affiliation":34,"role":35},"Andrew Thamboo","St Paul's Sonis Centre Director","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":30,"email":40},"CONTACT","604-250-4174","andrew.thamboo@gmail.com",{"name":42,"role":38,"phone":39,"phoneExt":30,"email":43},"Leonora Beltran","lbeltranjimenez@providencehealth.bc.ca",{"type":45,"investigatorFullName":46,"investigatorTitle":47,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Dr. Andrew Thamboo, MD","Clinical Assistant Professor",[49],{"name":50,"class":51},"Sanofi","INDUSTRY","100558833","phase-4-immunologic-impact-of-dupilumab-in-patients-suffering-from-asthma-and-chronic-rhinosinusitis-with-polyps-100558833",false,"NCT06556264","Immunologic Impact of Dupilumab in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps","Determining the Immunologic Impact of Dupilumab on the Unified Airway System in Patients Suffering From Asthma and Chronic Rhinosinusitis With Polyps","Inclusion Criteria:\n\n* Patients over the age of 19.\n* Patients undergoing Endoscopic Sinus Surgery (ESS)\n* Patients with CRSwNP with moderate-severe asthma according to 2020 EPOS criteria:\n\n  1. Asthma confirmed with spirometry and assessment on the previous history of asthma (a methacholine challenge test and atopy testing to document the positive or negative history of asthma will be performed if there is no clinical record). Asthma severity based on GINA guidelines.\n  2. Presence of nasal polyps. This can be based on the formal exam at Baseline Visit or historical assessment.\n\nExclusion Criteria:\n\n* Patients with current or past sinonasal or bronchial tumours\n* Subjects who have been treated with oral antibiotics in the past month prior to surgery\n* Subjects with known immunodeficiency\n* Subjects with known autoimmune disease\n* Subjects with other sinonasal diseases other than CRSwNP (e.g., cystic fibrosis, eosinophilic granulomatosis with polyangiitis, allergic fungal rhinosinusitis, invasive fungal sinusitis, fungal ball, dyskinetic cilia syndrome)\n* Prior lung transplants\n* Subjects with hypersensitivity; with allergy\u002Fintolerance to a monoclonal antibody or biologic\n* Prior use of dupilumab or other biologic medications (omalizumab. mepolizumab, reslizumab,etc) 6 months before enrollment.\n* Any condition that, in the opinion of the investigator, may interfere with the patient's ability to participate in the study per protocol.\n* Participation in an ongoing interventional or observational study using a biologic treatment.\n* Female participants who are pregnant or breastfeeding","ALL","19 Years",{"count":62,"type":63},60,"ESTIMATED","INTERVENTIONAL",[66],"PHASE4","The investigators are studying adults who have chronic rhinosinusitis with nasal polyps (CRSwNP) and moderate to severe asthma, and who are undergoing Endoscopic Sinus Surgery (ESS). Investigators want to understand how adding a medication called dupilumab to their usual treatment affects inflammation in their upper and lower airways over 24 weeks.\n\nDupilumab works by blocking certain signals in the immune system that contribute to inflammation in both the sinuses and the lungs. By studying how this medication changes the immune profiles of both airway systems, investigators hope to learn more about the underlying causes of airway inflammation in these conditions.\n\nThis research is important because it may help understand if treating inflammation in one part of the airway (like the lungs) has a similar effect on inflammation in another part (like the sinuses). This could lead to better treatments for people with CRSwNP and asthma, targeting the root causes of their symptoms more effectively.",[69,70],"Chronic Rhinosinusitis With Nasal Polyps","Asthma","NOT_YET_RECRUITING","2024-08-13",{"date":74,"type":75},"2024-08-16","ACTUAL",{"date":77,"type":63},"2024-08",{"date":79,"type":63},"2025-12",{"name":46,"class":6}]