Effect of Dupilumab on nasal epithelial barrier function in patients with Chronic Rhinosinusitis with nasal polyps (CRSwNP) – an exploratory pilot study - EpiBar

Medical University Of Vienna0 个研究点目标入组 80 人开始时间: 2024年1月8日最近更新: 2024年7月22日

适应症

试验速览

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•18-99 years of age, Willingness to participate in the study, Suffer from chronic rhinosinusitis defined as in EPOS 2020 criteria, see main text, Group 1 (n=20, CRSsNP): Absence of nasal polyps, Group 2 (N=60, CRSwNP): Presence of nasal polyps as confirmed by endoscopy or CT and planned therapy with dupilumab, Presence or absence of non-steroidal anti-inflammatory drug (NSAID)-Exacerbated Respiratory Disease (N-ERD), Patients with a history of treatment with monoclonal antibodies for asthma or polyps will only be included if at least a washout period of 6 months has passed

•Pregnancy (as determined by ß-HCG test) or breast feeding, Patients with severe anatomic variations or deviations that do not allow access to all areas in the nasal cavity, Patients with cystic fibrosis or primary ciliary dyskinesia, Patients with permanent immunosuppression, A mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study, Patients with clinically meaningful comorbidity as determined by the evaluating committee, Patients with a history of exacerbation of chronic rhinosinusitis 4 weeks prior to the screening visit, Intake of a burst of systemic corticosteroids for the treatment of CRS 4 weeks prior to the screening visit

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