[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Dr. Andrew Thamboo, MD\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":60},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,39],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":21,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":4},"100572959","phase-3-opening-the-black-box-on-tezepelumabs-effect-on-chronic-rhinosinusitis-with-severe-asthma-100572959",false,"NCT06740045","Opening the \"Black Box\" on Tezepelumab's Effect on Chronic Rhinosinusitis With Severe Asthma","Inclusion Criteria:\n\n* Must be ≥19 of age at the time of signing the informed consent form\n* Capable of giving signed informed consent.\n* Having CRSwNP based on clinical symptoms and\u002For radiographic or endoscopic evidence of inflammation in their upper airways (Diagnosis consistent with EPOS 2020)(2)and severe asthma:\n\n  * SA based on GINA criteria (37) and confirmed with spirometry and assessmenton the previous history of asthma (a pre-post bronchodilator spirometry ormethacholine challenge to document the positive or negative history of asthmawill be performed if there is no clinical record).\n  * Nasal polyp score (NPS) of at least 2 on each side\n* Females of childbearing potential must commit using an acceptable method of birthcontrol for the duration of the study and they must have a negative urine pregnancy test ateach study visit\n* Not expecting to have surgery within the next 7 months\n\nExclusion Criteria:\n\n* Have previously undergone sinus surgery or nasal polypectomy\n* A history of organ transplantation such as lung transplantation\n* Previously or currently using immunomodulator medications or antihistamines\n* A history of auto-immune diseases\n* Current or past sinonasal or bronchial tumors\n* Currently using systemic or oral corticosteroids\n* Women who are pregnant, plan to become pregnant, or breastfeed during the trial\n* Current participation in any other interventional treatment trials\n* Compliance: is unlikely to comply with study visits based on investigator judgment:\n* Diagnosed or suspected malignant or premalignant nasal disease (e.g. SchniderianPapilloma, unilateral nasal polyposis)\n* Fungal rhinosinusitis (CT\u002FHistology), positive Aspergillus skin prick testing and\u002Forpositive Aspergillus IgE RAST (Radioallergosorbent) testing\n* Malignant neoplasm within 5 years (from screening) excluding basal cell or squamouscell carcinoma of the skin treated with local resection only or carcinoma in situ of the uterinecervix treated locally and without metastatic disease for 3 years.\n* Active bleeding disorders, and\u002For inability to support interruption to anticoagulant or anti-platelet therapies for nasal biopsy.\n* Severe nasal deformity precluding endoscopic assessment\u002Fbiopsy of postnasal space\n* Have an acute or chronic infection (excluding that related to CRS) requiring managementas follows:\n\n  * Currently on any treatment for a chronic infection such as pneumocystis,cytomegalovirus, herpes simplex virus, herpes zoster, or atypical mycobacteria\n  * Hospitalisation solely for the treatment of proven infection requiring parenteral (IV orIM) antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60days of Day 1\n  * Proven severe infection requiring outpatient treatment with parenteral (IV or IM)antibiotics (antibacterial, antiviral, antifungal, or anti-parasitic agents) within 60 daysof Day 1. Prophylactic anti-infective treatment is allowed.\n* Known positive human immunodeficiency virus (HIV) status\n* Known positive Hepatitis B (HB) or Hepatitis C status\n* Have clinical evidence of significant unstable or uncontrolled acute or chronic diseaseswhich, in the opinion of the principal investigator, could confound the results of the study orput the participant at undue risk\n* Have a planned surgical procedure, laboratory abnormality, or condition that, in theopinion of the principal investigator, makes the participant unsuitable for the study.\n* Have received any investigational agent (that is not approved for sale in Canada) within60 days of Day 1\n* Smoking history; current or former smokers with a smoke history of packs year \\>15\n* Subjects with parasitic (helminthic) infection\n* Subjects with hypersensitivity; with allergy\u002Fintolerance to a monoclonal antibody or biologics\n* Subjects allergic to Aspirin (ASA) and non-steroidal anti-inflammatory drugs (NSAIDs)","ALL","19 Years",{"count":18,"type":19},10,"ESTIMATED","INTERVENTIONAL",[22],"PHASE3","The study explores how chronic rhinosinusitis (CRS) and asthma share a common inflammatory process, particularly affecting patients with both conditions. Interaction between immune cells (Interleukins) and Th2 cytokines, such as TSLP, exacerbates asthma control in CRS patients, especially those with nasal polyps (CRSwNP). TSLP plays a pivotal role in initiating and maintaining airway inflammation in both diseases. Tezepelumab, a biologic therapy targeting TSLP, shows promise in reducing inflammation markers in severe asthma but its impact on CRSwNP and quality of life remains unclear. The study proposes investigating Tezepelumab's efficacy in treating CRSwNP and severe asthma to inform future biologic therapies.",[25,26],"Asthma","Chronic Rhinosinusitis With Nasal Polyps","NOT_YET_RECRUITING","2024-12-13",{"date":30,"type":31},"2024-12-18","ACTUAL",{"date":33,"type":19},"2025-01",{"date":35,"type":19},"2025-06",{"name":37,"class":38},"Dr. Andrew Thamboo, MD","OTHER",{"id":40,"slug":41,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":15,"minAge":16,"maxAge":4,"enrollmentInfo":46,"targetDuration":4,"studyType":20,"phases":48,"briefSummary":50,"conditions":51,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":52,"lastUpdatePostDateStruct":53,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":4},"100558833","phase-4-immunologic-impact-of-dupilumab-in-patients-suffering-from-asthma-and-chronic-rhinosinusitis-with-polyps-100558833","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",{"count":47,"type":19},60,[49],"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.",[26,25],"2024-08-13",{"date":54,"type":31},"2024-08-16",{"date":56,"type":19},"2024-08",{"date":58,"type":19},"2025-12",{"name":37,"class":38},""]