NL-OMON54163招募中4 期
MONOPOLY: predicting clinical benefit of dupilumab in adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) - Dupilumab in patients with CRSwNP
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 130
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99(—)
入选标准
- •bilateral CRSwNP (EPOS2020 criteria)
- •>= 18 years
- •indication for biological (EPOS2020 criteria) and starting treatment with
- •(for EPOS 2020 criteria see reference in METC protocol)
排除标准
- •age < 18 years
- •pregnancy
- •patient is not able to complete SNOT-22 questionnaire in NL or EN
- •strong indication for surgical treatment (e.g.: mucoceles)
- •systemic diseases affecting the nose (e.g.: GPA, EGPA, sarcoid, primary
- •ciliary dyskinesia, cystic fibrosis)
- •antrochoanal polyps (isolated benign polyps originating from the mucosa of
- •the maxillary sinus with a distinctive small stalk)
- •inverted papilloma and malignant polyps
- •acute upper or lower respiratory tract infections within 2 weeks before the
- •inclusion visit
- •use of systemic corticosteroids within 4 weeks before the inclusion visit
- •need of continuous systemic corticosteroid treatment for other disease than
- •systemic diseases preventing participation in the study (all comorbidities
- •that have a higher impact on quality of life than CRSwNP and/or making the
- •patient at risk during the study period)
- •other systemical medical treatments influencing disease or primary and
- •secondary study outcome measurements such as (non-)selective immunosuppressants
- •(e.g.: azathioprine, methotrexate), excluding co-treatment with other type-2
- •biologicals for indication of CRSwNP and/or Asthma.
研究者
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