A Randomized, Real-world Head-to-head Study of Dupilumab Versus Mepolizumab in Danish CRSwNP Patients

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 220

Inclusion 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. - Previous treatment failure with one of the IMPs for any indication (treatment failure is defined as failure to achieve the desired therapeutic outcome or effectively manage a condition within an expected timeframe) - Eosinophilic blood cell count of =1.5x10^9cells/L (at baseline, i.e. before first injection) - Pronounced fear of needles - Pregnant or breastfeeding patients

Exclusion Criteria

Not provided

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
SNOT-22;NPS

Secondary Outcome Measures

Name	Time	Method
SNOT-22;NPS;Smell score (Sniffin' Sticks Identification Test-16- SSIT-16);Asthma control (Asthma Control Questionnaire);Nasal Congestion Score (NCS);Visual Analogue Scale of: smell/asthma/Chronic rhinosinusitis/N-ERD;Proportion meeting the evaluation criteria set by the DMC;Fraction of Nitrous Oxide in expired air (FeNO);Proportion needing rescue treatment