EUCTR2018-002466-39-NL进行中(未招募)1 期
Morphine or Fentanyl for Refractory dyspnea in COPD - MoreFoRCOPD
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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