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Recruiting NCT06398873

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

— Observational Chronic Rhinosinusitis With Nasal Polyps Chronic Rhinosinusitis Without Nasal Polyps

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT].
Who it may be relevant to
Registry conditions: Chronic Rhinosinusitis With Nasal Polyps, Chronic Rhinosinusitis Without Nasal Polyps. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • Drug Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT]
    300mg/2 weeks

Primary outcome measures

  • Barrier function in CRSsNP and CRSwNP [Time frame: 1 Visit (baseline)]
  • Barrier function in CRSwNP with Dupilumab [Time frame: 3 Visits (baseline, 3 months, 6 months)]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Austria · 1 center
  • Medical University of Vienna — Vienna

Publications

  • 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 pat PMID 31543428
  • 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

Identifiers

NCT: NCT06398873 · EpiBar

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗