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Treatment of rhinosinusitis with nasal polyposis with dupilumab and mepolizumab: A randomized, multi-centre, head-to-head comparison in real-world Danish patients

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502250-14-00
Acronym
TORNADO
Enrollment
220
Registered
2023-03-22
Start date
2023-04-13
Completion date
Unknown
Last updated
2025-10-29

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

Conditions

Chronic rhinosinusitis with nasal polyposis

Brief summary

Co-primary endpoint 1: Change in nasal polyp score (NPS) at 24 weeks, Co-primary endpoint 2: Change in SNOT-22 score at 24 weeks

Detailed description

Change in loss of smell (Proportion with SSIT-16 improved to >8), Improvement in asthma (measured by proportion with ACQ>0.5), Improvement on visual analog scale measuring impact on quality of life of CRSwNP, Tympanometry - proportion with change from B-curve to A or C curve., Expired Nitrous oxide (FeNO) - proportion with less than 25 ppb, Improvement in subjective smell function by visual analog scale, Improvement in aspirin-exacerbated-respiratory-intolerance (AERD) measured by visual analog scale., Improvement in NPS at 52 weeks, Improvement in SNOT-22 at 52 weeks, Proportion meeting the response criteria set by the Danish Medicines council, Proportion of subjects needing rescue treatment (systemic corticosteroids or sinus surgery), Change in Nasal Congestion Score (NCS), Chang in radiologic sinus opacification (Lund-Mackey score), Change in FEV1

Interventions

Sponsors

Rigshospitalet
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Co-primary endpoint 1: Change in nasal polyp score (NPS) at 24 weeks, Co-primary endpoint 2: Change in SNOT-22 score at 24 weeks

Secondary

MeasureTime frame
Change in loss of smell (Proportion with SSIT-16 improved to >8), Improvement in asthma (measured by proportion with ACQ>0.5), Improvement on visual analog scale measuring impact on quality of life of CRSwNP, Tympanometry - proportion with change from B-curve to A or C curve., Expired Nitrous oxide (FeNO) - proportion with less than 25 ppb, Improvement in subjective smell function by visual analog scale, Improvement in aspirin-exacerbated-respiratory-intolerance (AERD) measured by visual analog scale., Improvement in NPS at 52 weeks, Improvement in SNOT-22 at 52 weeks, Proportion meeting the response criteria set by the Danish Medicines council, Proportion of subjects needing rescue treatment (systemic corticosteroids or sinus surgery), Change in Nasal Congestion Score (NCS), Chang in radiologic sinus opacification (Lund-Mackey score), Change in FEV1

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026