A Randomized, Real-world Head-to-head Study of Dupilumab Versus Mepolizumab in Danish CRSwNP Patients (TORNADO)
Chronic Rhinosinusitis With Nasal Polyps, Asthma; Eosinophilic, Eosinophilia
About this trial
This is an interventional treatment trial for Chronic Rhinosinusitis With Nasal Polyps
Eligibility Criteria
Inclusion Criteria: Bilateral polyps in nose and sinuses ESS within the last three years (unless unfit for surgery y- in this study defined as either a severe somatic disease, for which other specialist advise against surgery, e.g., cardiac disease, pulmonary disease, or coagulation disorder OR/AND severe anxiety which can either be due to previous traumatic experiences with surgery or the postoperative period, post-traumatic stress disorder or severe anxiety disorder. In cases of doubt, investigators can ask for a written statement from the general practitioner or a psychiatrists/psychologist)) Optimal local treatment with saline irrigation and topical nasal steroids for at least three months (unless contraindicated) Evidence of type 2 inflammation Furthermore, patients must fulfil three out the following five criteria: Need for systemic corticosteroids (at least two courses/year OR long-term treatment >3 months) or contraindication to systemic steroids Significantly impaired QoL (SNOT-22 score≥50) Significant LoS (SSIT-16 score 0-8) NPS ≥5 (with at least 2 on either side) Asthma diagnosis (requiring inhaled corticosteroid (ICS)) Also: Age of 18 years or more and able to read and/or speak Danish Exclusion criteria Systemic corticosteroid treatment within the last three months Endoscopic sinus surgery (ESS) within the last six months Non-adherent to medicine regimens Hypersensitivity to the active substance or any of the excipients in the two IMPs Not able to understand spoken and/or written Danish Participation-current or previous (within the last year)-in another investigational drug trial with monoclonal antibodies for asthma, CRSwNP, atopic dermatitis or allergic rhinitis. Pronounced fear of needles Pregnant or breastfeeding patients
Sites / Locations
- Aalborg Universitetssygehus Syd
- Aarhus Universitetshospital Skejby
- RigshospitaletRecruiting
- Sydvestjysk Sygehus Esbjerg
- Regionshospitalet Gødstrup
- Nordsjællands Hospital
- Sjællands Universitetshospital KøgeRecruiting
- Odense UniversitetshospitalRecruiting
- Sygehus Lillebælt VejleRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Dupilumab week 0-24 300 mg/2 weeks
Mepolizumab week 0-24 100 mg/4 weeks
Dupilumab week 24-48 300 mg/4 weeks
Dupilumab week 24-48 300 mg/2 weeks
Mepolizumab week 24-48 100 mg/4 weeks
Normal dose and interval of Dupixent i.e. 300 mg s.c. every 2 weeks
Normal dose and interval of Nucala i.e. 100 mg s.c. every 4 weeks
Increased dosage interval of Dupixent i.e. 300 mg s.c. every 4 weeks - for subjects on Dupixent who met the 24 weeks effect criteria
Normal dose and interval of Dupixent i.e. 300 mg s.c. every 2 weeks but for subjects who have crossed over after 24 weeks due to unmet effect criteria.
Normal dose and interval of Nucala i.e. 100 mg s.c. every 4 weeks but for subjects who have crossed-over after 24 weeks due to unmet effect criteria.