Study of Dupilumabs Impact on Nasal Epithelial Barrier in Adults with Chronic Rhinosinusitis With and Without Nasal Polyps
Led by Medical University of Vienna · Updated on 2025-05-07
80
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
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.
CONDITIONS
Brief Title
Effect of Dupilumab on Nasal Epithelial Barrier Function in Patients With CRSwNP
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match. Sign up to get personalized trial recommendations delivered to your inbox.
Have more questions? Get in touch with our team for quick support
Published Research Related To This Trial
Efficacy and safety of dupilumab in patients with severe chronic rhinosinusitis with nasal polyps (LIBERTY NP SINUS-24 and LIBERTY NP SINUS-52): results from two multicentre, randomised, double-blind, placebo-controlled, parallel-group phase 3 trials.