Chronic rhinosinusitis with nasal polyps, Chronic rhinosinusitis without nasal polyps
Conditions
Brief summary
Primary endpoint is the change in barrier sensitivity (Cell index) (1) at visit 1 (baseline) in stimulated versus unstimulated cells of patients suffering from CRSsNP or CRSwNP as compared to disease controls as well as in (2) CRSwNP patients at V1 and after 6 months of dupilumab treatment (V3).
Detailed description
Change in barrier sensitivity as described in primary endpoint in patients over time (0, 3 and 6 months), Expression levels of tight junction proteins (by mass cytometry imaging – percentage of positive cells and intensity of staining) in selected biopsies and fixed cultured primary cells in diseased patients and compared to disease controls, Cytokine levels (pg/ml) in nasal mucosal lining fluids of diseased patients and compared to disease controls, Association of barrier sensitivity and cytokine levels, Microbiome (Diversity, Shannon index) in diseased patients and compared to disease controls, Association of barrier sensitivity and microbiome composition, Transcriptome (differentially expressed genes and pathway analysis) and cytokine levels (pg/ml) in selected cultured cells derived from diseased patients and compared to disease controls, Association of experimental (change in barrier function, transcriptome, etc.) with clinical data (TPS, SNOT-22, etc.)
Interventions
Sponsors
Medical University Of Vienna
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint is the change in barrier sensitivity (Cell index) (1) at visit 1 (baseline) in stimulated versus unstimulated cells of patients suffering from CRSsNP or CRSwNP as compared to disease controls as well as in (2) CRSwNP patients at V1 and after 6 months of dupilumab treatment (V3). | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in barrier sensitivity as described in primary endpoint in patients over time (0, 3 and 6 months), Expression levels of tight junction proteins (by mass cytometry imaging – percentage of positive cells and intensity of staining) in selected biopsies and fixed cultured primary cells in diseased patients and compared to disease controls, Cytokine levels (pg/ml) in nasal mucosal lining fluids of diseased patients and compared to disease controls, Association of barrier sensitivity and cytokine levels, Microbiome (Diversity, Shannon index) in diseased patients and compared to disease controls, Association of barrier sensitivity and microbiome composition, Transcriptome (differentially expressed genes and pathway analysis) and cytokine levels (pg/ml) in selected cultured cells derived from diseased patients and compared to disease controls, Association of experimental (change in barrier function, transcriptome, etc.) with clinical data (TPS, SNOT-22, etc.) | — |
Countries
Austria
Outcome results
None listed