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

Recruiting

• Conditions: Chronic Rhinosinusitis With Nasal Polyps; Chronic Rhinosinusitis Without Nasal Polyps
• Interventions: Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

• Registration Number: NCT06398873
• Lead Sponsor: Medical University of Vienna

Brief 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.

Study Timeline

• Study First Submitted: 2024-04-25
• Study First Submitted QC: 2024-04-30
• Study First Posted: 2024-05-03
• Status Verified: 2024-06
• Study Start: 2024-06-06
• Last Update Submitted: 2025-05-06
• Last Update Posted: 2025-05-07
• Primary Completion: 2026-09-01
• Study Completion: 2027-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• 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 will only be included if at least a washout period of 6 months has passed

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CRSwNP	Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]	Dupilumab

Primary Outcome Measures

Name	Time	Method
Barrier function in CRSwNP with Dupilumab	3 Visits (baseline, 3 months, 6 months)	Cell index (xCELLigence)
Barrier function in CRSsNP and CRSwNP	1 Visit (baseline)	Cell index (xCELLigence)

Trial Locations

Locations (1)

Medical University of Vienna; 🇦🇹 Vienna, Austria