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

NCT ID: NCT06398873

Last Updated: 2025-05-07

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 80 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-06
• Study Completion Date: 2027-09-01

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps; Chronic Rhinosinusitis Without Nasal Polyps

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

CRSsNP

No interventions assigned to this group

CRSwNP

Dupilumab

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Intervention Type: DRUG

300mg/2 weeks

Interventions

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

300mg/2 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Vienna

OTHER

Sponsor Role: lead

Responsible Party

Sven Schneider, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Medical University of Vienna

Vienna, Austria, Austria

Site Status: RECRUITING

Countries

Austria

Facility Contacts

Julia Eckl-Dorna, MD, PhD

Role: primary

julia.eckl-dorna@meduniwien.ac.at

004314040034380

Victoria Stanek, MA

Role: backup

victoria.stanek@meduniwien.ac.at

References

Bachert C, Han JK, Desrosiers M, Hellings PW, Amin N, Lee SE, Mullol J, Greos LS, Bosso JV, Laidlaw TM, Cervin AU, Maspero JF, Hopkins C, Olze H, Canonica GW, Paggiaro P, Cho SH, Fokkens WJ, Fujieda S, Zhang M, Lu X, Fan C, Draikiwicz S, Kamat SA, Khan A, Pirozzi G, Patel N, Graham NMH, Ruddy M, Staudinger H, Weinreich D, Stahl N, Yancopoulos GD, Mannent LP. 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. Lancet. 2019 Nov 2;394(10209):1638-1650. doi: 10.1016/S0140-6736(19)31881-1. Epub 2019 Sep 19.

Reference Type: BACKGROUND

PMID: 31543428 (View on PubMed)

Schneider S, Poglitsch K, Morgenstern C, Quint T, Gangl K, Sinz C, Bartosik T, Campion NJ, Liu DT, Landegger LD, Tu A, Stanek V, Rocha-Hasler M, Bangert C, Eckl-Dorna J. Dupilumab increases aspirin tolerance in NSAID-exacerbated respiratory disease. Eur Respir J. 2023 Mar 16;61(3):2201335. doi: 10.1183/13993003.01335-2022. Print 2023 Mar.

Reference Type: BACKGROUND

PMID: 36549708 (View on PubMed)

Other Identifiers

EpiBar

Identifier Type: -

Identifier Source: org_study_id