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临床试验/EUCTR2013-003619-24-ES
EUCTR2013-003619-24-ES进行中(未招募)1 期

Benefits of liquid oxygen in COPD patients without evidence of domiciliary oxygen therapy, presenting desaturation on exertion.

ourdes Lozano-Bailen0 个研究点目标入组 112 人开始时间: 2013年12月13日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
112

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

  • -Patients diagnosed with moderate - severe COPD (FEV1 <80%, FEV1/FVC <70%), total lung capacity (TLC)> 80% of the reference values (GesEPOC Stadium II-IV/GOLD III-IV)
  • - Do not meet conventional criteria for Long term oxygen therapy (LTOT) indication (SEPAR Guides and GOLD)
  • - Stability clinic in the last month
  • - Optimized medical treatment
  • - SpO2 mean ? 88% in the six minute walking test (6MWT)
  • - Active life
  • 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 12
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 100

排除标准

  • - Current smokers
  • - Respiratory failure with criteria for LTOT (PaO2 <55 mmHg or 55-60 mmHg associated with pulmonary hypertension, cor pulmonale, congestive heart failure, arrhythmias or polycythemia).
  • - Impaired mobility
  • - Cognitive impairment or intellectual disability
  • - Disagreement to use liquid oxygen out of home
  • - Severe comorbidities
  • - Participation in pulmonary rehabilitation program

研究者

发起方
ourdes Lozano-Bailen

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