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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CRSsNP | |||
| CRSwNP | Dupilumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dupilumab 300 MG/2 ML Subcutaneous Solution [DUPIXENT] | Drug | 300mg/2 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic rhinosinusitis with and without nasal polyps
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Recruiting | Vienna | Austria | A-1090 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31543428 | Background | 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. | |
| 36549708 |
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IPD will be shared upon reasonable request
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| ID | Term |
|---|---|
| C582203 | dupilumab |
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Serum, primary nasal epithelial cells
| 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. |