Treatment of rhinosinusitis with nasal polyposis with dupilumab and mepolizumab: A randomized, multi-centre, head-to-head comparison in real-world Danish patients - TORNADO

Rigshospitalet0 个研究点目标入组 220 人开始时间: 2023年1月13日最近更新: 2024年7月22日

适应症

试验速览

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•Chronic Rhinosinusitis with bilateral nasal polyposis, Age above 18 years, Able to read and/or speak Danish, Evidence of type 2 inflammation as measured by either eosinophilia in blood or tissue (in accordance with EPOS2020), or late-onset eosinophilic asthma, At least one endoscopic sinus surgery within the previous seven years (or not being fit to undergo sinus surgery), Adherence to nasal steroid spray and nasal douches twice a day for a period of at least three months until start of treatment, Additionally: at least three of the following five: 1) need for systemic corticosteroids (OCS), at least two/year or one long term treatment lasting more than three months, or having contraindications to OCSs, 2) Sino-nasal outcome test 22 (SNOT-22) score of at least 50, 3) Reduced sense of smell (Defined as Sniffin Sticks-Evaluation Identification Test 16 (UPSIT-16) score 0-8, 4) Nasal polyp score (NPS) of minimum 2 on both sides, and a minimum score of 5 in total, 5) Asthma requiring inhaled corticosteroids

•Systemic corticosteroid treatment within the last three months, Pregnant or breastfeeding patients., Endoscopic sinus surgery (ESS) within the last six months, Non-adherent to medicine regimens, Hypersensitivity to the active substance or any of the excipients in the two IMPs, Not able to understand spoken and/or written Danish, Prior treatment with any biologic drug aimed at type II disease within the previous six months, Prior treatment failure with one of the two IMPs for any indication, Eosinophilic blood cell count of =1.5x109cells/L (at baseline, i.e. before first injection), Pronounced fear of needles

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