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临床试验/DRKS00034017
DRKS00034017招募中不适用

Development of an assay for endotyping nasal polyps via Interleukin-5 signaling and predicting a response to mepolizumab therapy

Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie, St. Josefs-Hospital Hagen der Kath. Krankenhaus Hagen GmbH0 个研究点目标入组 60 人开始时间: 2024年4月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60

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 Years 至 one(—)
性别
All

入选标准

  • Recurrence of bilateral nasal polyps after one or more sinus surgeries despite current therapy with local and/or systemic cortisone therapy
  • - Nasal polyp score = 4 out of 8
  • - SNOT-22 (sino-nasal outcome test-22) = 35 points
  • - total symptom VAS (visual analog scale) = 5 out of 10 cm or 10 out of 20 cm
  • - Evidence of type 2 inflammation [13]: Tissue eosinophils = 10/hpf17 or blood eosinophils = 250u/l or total IgE = 100IU/ml

排除标准

  • - Infectious diseases such as HIV, hepatitis B and C
  • - Tumor diseases
  • - Autoimmune or non-type 2 inflammatory diseases
  • - Alcohol consumption in the last 4 weeks and positive rapid test kit result of ethyl glucuronide in urine
  • - Cigarette consumption in the last 4 weeks and positive rapid test kit result of cotinine in urine
  • - Use of illegal drugs in the last 12 weeks and positive rapid test kit result
  • - Therapy with other biologics in the last 12 weeks
  • - Acute infection or elevation of both leukocytes and C-reactive protein in the blood
  • - Use of systemic steroids in the last 4 weeks18
  • - pregnancy and breast-feeding

研究者

发起方
Klinik für Hals-Nasen-Ohrenheilkunde, Kopf- und Halschirurgie, St. Josefs-Hospital Hagen der Kath. Krankenhaus Hagen GmbH

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