SYF532d562847684f7fa5847cb08ada6892Registry ID: 2025-524495-39-00|Not Yet RecruitingPhase 4
DIRECTION Study
Direct comparison of Tezepelumab and Dupilumab in CRSwNP in a real world setting
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Direct comparison of Tezepelumab and Dupilumab in CRSwNP in a real world setting
interventional
N/A
1 country
8
To compare Tezepelumab and Dupilumab with respect to a clinical meaningful improvement of nasal polyp disease as defined by a minimal reduction of nasal polyp score (NPS) by 1 point or a reduction in sino-nasal outcome test SNOT)-22 by 8.9 points between baseline and 12 months
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 18, 2025
Actual (reported)The change in NPS score (0-8 points) or the change in SNOT-22 (Scale of 0-110) from baseline to 12 months.
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
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
Tezspire 210 mg solution for injection in pre-filled syringe
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordFormulated product
Dupixent 200 mg solution for injection in pre-filled pen
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
Tezspire 210 mg solution for injection in pre-filled syringe
Named ingredient: tezepelumab
View registry recordDupixent 200 mg solution for injection in pre-filled pen
Named ingredient: dupilumab
View registry recordMedizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Landeskrankenanstalten-Betriebsgesellschaft Kabeg
Klagenfurt Am Woerthersee, 9020, Austria
Tauernkliniken GmbH
Zell Am See, 5700, Austria
Department of Ear, Nose and Throat Disease
First Submitted
December 18, 2025
Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved:
Contact the study team to confirm eligibility.
Kepler Universitaetsklinikum GmbH
Linz, 4020, Austria
Ordensklinikum Linz GmbH
Linz, 4010, Austria
Medical University Of Vienna
Vienna, 1090, Austria
Medical University Of Graz
Graz, 8010, Austria
Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH
Salzburg, 5020, Austria