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

Study acronym: TORNADO
StatusActive, Not Recruiting
PhasePhase 4
Started
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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.

Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Feb 27, 2026 to Apr 1, 2026
    • Study completion date: Mar 27, 2026 to May 1, 2026
    • Site details revised at 9 of 9 sites
    • Study title expanded, about 4 words
  2. Primary completion date: Oct 30, 2025 to Feb 27, 2026v2 Show 4 more changesShow less
    • Study completion date: Jan 2026 to Mar 27, 2026
    • Eligibility criteria expanded, about 44 words
    • Site details revised at 5 of 9 sites
    • Study description expanded, about 4 words
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05942222
Lead Sponsor Copenhagen University Hospital, Rigshospitalet
Conditions
(from sponsor)		 Chronic Rhinosinusitis With Nasal Polyps, Asthma; Eosinophilic, Eosinophilia
Related terms Eosinophilia, Pulmonary Eosinophilia
Enrollment 220 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov