Skip to content

Direct comparison of Tezepelumab and Dupilumab in CRSwNP in a real world setting

Status
Not yet recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2025-524495-39-00
Enrollment
220
Registered
2026-03-22
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis with Nasal Polyps

Brief summary

The change in NPS score (0-8 points) or the change in SNOT-22 (Scale of 0-110) from baseline to 12 months.

Detailed description

Percentage of patients with good-excellent (4-5 criteria), poor-moderate (1-3 criteria) and no response (0 criteria) according to EPOS/EUROFREA criteria during one year of therapy with Dupilumab or Tezepelumab, Change in in QoL parameters (e.g., SNOT-22 score and subcategories, scale 0-110, EQ-5D-3L, scale: 5-15) and clinical parameters (e.g. NPS, scale: 0-8; ECP, 0-200µg/L) during one year of therapy with Dupilumab or Tezepelumab, Change in objective (Sniffin’sticks, 0-16 points) and subjective (VAS for olfactory performance (0-10cm), SNOT 22 items) during one year of therapy with Dupilumab or Tezepelumab, change in peak nasal inspiratory flow (PNIF, 0-370 L/min) or FEV 1 (spirometer, 0-ca.120%(young patients)) during one year of therapy with Dupilumab or Tezepelumab, change in perception of asthma control (ACT 0-25 Points or AQLQ 0-105 points) during one year of therapy with Dupilumab or Tezepelumab, change in perception of CRS symptoms (VAS, 0-10 cm) during one year of therapy with Dupilumab or Tezepelumab, occurrence of side effect as determined by diary or patients oral report during one year of therapy with Dupilumab or Tezepelumab, change in routine blood parameters, Change in allergic symptoms (TRSS 0-21 points, questionnaire) and allergic sensitization (skin prick test, number of sensitizations) during one year of treatment with Dupilumab or Tezepelumab, Change in diversity (Chao1 and Shannon Index, 0-open) and abundance (0-open) of the nasal microbiome during one year of treatment with Dupilumab or Tezepelumab, Change in relative levels of mediators (Normalized Protein Expression=NPX, 0-open) as determined by OLINK during one year of treatment with Dupilumab or Tezepelumab, Change in relative gene expression (Δ Cycle threshold (Ct): Difference between Ct of the target gene and a reference gene, 0-open) of oxidative stress response induced genes during one year of treatment with Dupilumab or Tezepelumab, Change in allergic sensitization (allergen-specific IgE levels, kUA/L) in nasal secretions and serum during one year of treatment with Dupilumab or Tezepelumab

Interventions

Sponsors

Medical University Of Vienna
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The change in NPS score (0-8 points) or the change in SNOT-22 (Scale of 0-110) from baseline to 12 months.

Secondary

MeasureTime frame
Percentage of patients with good-excellent (4-5 criteria), poor-moderate (1-3 criteria) and no response (0 criteria) according to EPOS/EUROFREA criteria during one year of therapy with Dupilumab or Tezepelumab, Change in in QoL parameters (e.g., SNOT-22 score and subcategories, scale 0-110, EQ-5D-3L, scale: 5-15) and clinical parameters (e.g. NPS, scale: 0-8; ECP, 0-200µg/L) during one year of therapy with Dupilumab or Tezepelumab, Change in objective (Sniffin’sticks, 0-16 points) and subjective (VAS for olfactory performance (0-10cm), SNOT 22 items) during one year of therapy with Dupilumab or Tezepelumab, change in peak nasal inspiratory flow (PNIF, 0-370 L/min) or FEV 1 (spirometer, 0-ca.120%(young patients)) during one year of therapy with Dupilumab or Tezepelumab, change in perception of asthma control (ACT 0-25 Points or AQLQ 0-105 points) during one year of therapy with Dupilumab or Tezepelumab, change in perception of CRS symptoms (VAS, 0-10 cm) during one year of

Outcome results

None listed

Source: EU CTIS · Data processed: Mar 23, 2026