Clinical Trial

A Real-world, Head-to-head Comparison of Dupilumab Versus Mepolizumab in Danish Patients With Chronic Rhinosinusitis With Nasal Polyps

Study acronym: TORNADO
Active, Not Recruiting Phase 4
View on ClinicalTrials.gov →
Record status
This record was last updated July 1, 2025 (before its estimated April 1, 2026 completion). Its status may not reflect the trial's current state.
Summary
The goal of this randomized clinical trial is to compare the effects of two newly available biological drugs for the treatment of severe chronic rhinosinusitis with nasal polyps in Danish patients. The main questions it aims to answer are whether the two drugs are comparable in effect after 24 weeks in terms of: * A subjective score (the SNOT-22) * An objective score, i.e.the physician-assessed score of nasal polyp size (the Nasal Polyp Score (0-8)) Methods: Participants will be randomized to receive one of the IMPs drug in the standard dose. After 24 weeks the effect is assessed by subjective and objective measures. If the criteria set by the Danish Medicinal Council are met (see elsewhere), treatment continues with the same drug for an additional 24 weeks. If the effect criteria are not met, the subject crosses-over to the opposite drug for an additional 24 weeks. After 48 weeks the effect is assessed once more.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2023-07-03; most recent amendment 2025-06-25.
Status change: Recruiting → Active, Not Recruiting 2025-06-25
Trial Details
NCT Number NCT05942222
Lead Sponsor Rigshospitalet, Denmark
Conditions Chronic Rhinosinusitis With Nasal Polyps, Asthma; Eosinophilic, Eosinophilia
Enrollment 220 participants
Start Date 2023-04-27
Primary Completion 2026-04-01 (estimated)
Study Completion 2026-05-01 (estimated)
Updated on ClinicalTrials.gov 2025-07-01