NCT06398873

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 80 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The investigators aim to investigate two major so far unresolved topics in CRSwNP research: (1) Thorough functional and molecular characterisation of barrier function in patients suffering from CRSsNP and CRSwNP and (2) effect of dupilumab treatment on barrier function in polyp patients. This will be achieved in patient-derived samples by employing measurement of barrier function in primary cell cultures in combination with a mass cytometry based imaging approach, transcriptomic analysis as well as cytokine and microbiome data of individual patients.

Detailed description

Primary objective 1: Characterization of differences in barrier function of the nasal epithelium in patients suffering from CRSsNP, CRSwNP with and without asthma or N-ERD (in absence of therapy with monoclonal antibodies). T Primary objective 2: Effect of dupilumab treatment on barrier function of the nasal epithelium in patients suffering from CRSwNP with and without asthma or N-ERD.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps
• Chronic Rhinosinusitis Without Nasal Polyps

Interventions

Type	Name	Description
DRUG	Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]	300mg/2 weeks

Timeline

• Start date: 2024-06-06
• Primary completion: 2026-09-01
• Completion: 2027-09-01
• First posted: 2024-05-03
• Last updated: 2025-05-07

Locations

1 site across 1 country: Austria