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临床试验/EUCTR2018-002466-39-NL
EUCTR2018-002466-39-NL进行中(未招募)1 期

Morphine or Fentanyl for Refractory dyspnea in COPD - MoreFoRCOPD

niversity Medical Center Groningen0 个研究点目标入组 60 人开始时间: 2018年11月19日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
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
Interventional clinical trial of medicinal product

入排标准

入选标准

  • COPD GOLD class III or IV, according to GOLD criteria.
  • - Post-bronchodilatation FEV1/FVC < 70% and FEV1 < 50% pred.
  • Complaints of refractory dyspnea as established by patient and doctor.
  • mMRC score = 3.
  • Life expectancy of = 2 months.
  • Optimized standard therapy according to Dutch LAN guideline for diagnosis and treatment of COPD.
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 30

排除标准

  • Other severe disease with chronic pain or chronic dyspnea (a non-susbstantial component of left sided heart failure is acceptable).
  • Current use of opioids for whatever indication
  • Allergy / intolerance for opioids
  • Psychiatric disease, not related to severe COPD.
  • Exacerbation of COPD eight weeks prior to inclusion or between screening and randomization.
  • Problematic (leading to medical help or social problems) substance abuse during the last five years.
  • Active malignancy, with the exception of planocellular or basal cell carcinoma of the skin.
  • eGFR <15 ml/min

研究者

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