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临床试验/NL-OMON54163
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

Academisch Medisch Centrum0 个研究点目标入组 130 人开始时间: 待定最近更新:
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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