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:
相关药物
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
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