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

NCT06398873 | Recruiting DMC

• 1 other identifier: EpiBar
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Rhinosinusitis With Nasal Polyps; Chronic Rhinosinusitis Without Nasal Polyps

Outcome Measures

Primary Outcomes (2)

• Barrier function in CRSsNP and CRSwNP

  Cell index (xCELLigence)

  1 Visit (baseline)

• Barrier function in CRSwNP with Dupilumab

  Cell index (xCELLigence)

  3 Visits (baseline, 3 months, 6 months)

Study Arms (2)

CRSsNP

CRSwNP

Dupilumab

Drug: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]

Interventions

Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] DRUG

300mg/2 weeks

CRSwNP

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with chronic rhinosinusitis with and without nasal polyps

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna

Vienna, Austria, A-1090, Austria

RECRUITING

Related Publications (2)

• 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.

  PMID: 31543428 BACKGROUND

• 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.

  PMID: 36549708 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Serum, primary nasal epithelial cells

MeSH Terms

Interventions

dupilumab

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: May 3, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 7, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)