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临床试验/EUCTR2008-001136-12-IT
EUCTR2008-001136-12-IT进行中(未招募)不适用

ONG-TERM OXYGEN THERAPY (LTOT) IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) PATIENTS WITH MODERATE CHRONIC HYPOXEMIA AND CHRONIC HEART FAILURE - LTOT IN COPD WITH CHRONIC HYPOXEMIA AND CHF

AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI0 个研究点开始时间: 2008年6月5日最近更新:
适应症
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
发起方

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

性别
All

入选标准

  • A patient will be eligible for inclusion in this study if all of the following criteria are met: 1. Male or female outpatients, aged 40-80 years inclusive, with a baseline post-bronchodilator FEV1 <80% of predicted normal, and post-bronchodilator FEV1/VC<70%. 2. An established clinical history of COPD according to the GOLD (5) 3. Moderate and stable chronic hypoxemia at rest (55< PaO2<65 mmHg) detected on 5 measurements separated by at least 2 weeks 4. Clinical signs of chronic heart failure according to the European Society of Cardiology (ESC) criteria (16), as certified by the local cardiology specialist 5. Ex smokers with > 20 pk/years having stopped for at least 3 months
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Patients will be excluded from the study if they have: 1.congenital heart disease, 2.lung cancer, or other cancers, 3.restrictive disorder (e.g. tuberculosis sequelae, interstitial pulmonary diseases); 4. other clinically significant coexisting severe diseases that could influence the survival in the study period.

研究者

发起方
AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI

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