2022-502250-14-00招募中4 期
Treatment of rhinosinusitis with nasal polyposis with dupilumab and mepolizumab: A randomized, multi-centre, head-to-head comparison in real-world Danish patients
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 9
- 主要终点
- Co-primary endpoint 1: Change in nasal polyp score (NPS) at 24 weeks
研究概览
简要总结
To compare the efficacy of mepolizumab versus dupilumab on objective and subjective symptoms of CRSwNP and related comorbidities in an attempt to determine non-inferiority between the two, or possibly; superiority of dupilumab over mepolizumab.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Chronic Rhinosinusitis with bilateral nasal polyposis
- •Age above 18 years
- •Able to read and/or speak Danish
- •Evidence of type 2 inflammation as measured by either eosinophilia in blood or tissue (in accordance with EPOS2020), or late-onset eosinophilic asthma
- •At least one endoscopic sinus surgery within the previous seven years (or not being fit to undergo sinus surgery)
- •Adherence to nasal steroid spray and nasal douches twice a day for a period of at least three months until start of treatment
- •Additionally: at least three of the following five: 1) need for systemic corticosteroids (OCS), at least two/year or one long term treatment lasting more than three months, or having contraindications to OCSs
- •Sino-nasal outcome test 22 (SNOT-22) score of at least 50
- •Reduced sense of smell (Defined as Sniffin Sticks-Evaluation Identification Test 16 (UPSIT-16) score 0-8
- •Nasal polyp score (NPS) of minimum 2 on both sides, and a minimum score of 5 in total
- •Asthma requiring inhaled corticosteroids
排除标准
- •Systemic corticosteroid treatment within the last three months
- •Pregnant or breastfeeding patients.
- •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
- •Prior treatment with any biologic drug aimed at type II disease within the previous six months
- •Prior treatment failure with one of the two IMPs for any indication
- •Eosinophilic blood cell count of ≥1.5x109cells/L (at baseline, i.e. before first injection)
- •Pronounced fear of needles
结局指标
主要结局
Co-primary endpoint 1: Change in nasal polyp score (NPS) at 24 weeks
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
Co-primary endpoint 2: Change in SNOT-22 score at 24 weeks
次要结局
- 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
- Change in FEV1
- 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)
研究者
Christian von Buchwald
Scientific
Rigshospitalet
研究点 (9)
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