Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With Chronic Rhinosinusitis With Nasal Polyps - an Exploratory Pilot Study

What this Trial Is About

Researchers are investigating two key unresolved questions in chronic rhinosinusitis with nasal polyps (CRSwNP) and without nasal polyps (CRSsNP). They aim to thoroughly examine the nasal epithelial barrier function in patients with these conditions and evaluate how dupilumab treatment affects this barrier in CRSwNP patients. This exploratory pilot study involves patients with or without asthma or NSAID-exacerbated respiratory disease (N-ERD) and focuses on both molecular and functional characteristics of nasal tissue. Participants with CRSsNP and CRSwNP will be studied, with the CRSwNP group receiving dupilumab 300 mg every two weeks by subcutaneous injection. Patients will be grouped based on the presence or absence of nasal polyps confirmed by endoscopy or CT, and some may have planned therapy with dupilumab. The study includes baseline assessments and follow-up visits at 3 and 6 months to observe treatment effects. During the study, participants will undergo measurements of nasal epithelial barrier function, primary cell culture analyses, and various molecular tests including mass cytometry imaging, transcriptomics, cytokine profiling, and microbiome analysis. Researchers will monitor barrier function at baseline and over time in those treated with dupilumab. The study requires participants to be between 18 and 99 years old and will involve multiple visits for comprehensive evaluation of nasal tissue and immune responses.

Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP