EUCTR2008-001136-12-IT
Active, Not Recruiting
N/A
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 sitesJune 5, 2008
ConditionsCOPD patients with moderate chronic stable hypoxemia and chronic heart failure.MedDRA version: 9.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disordersMedDRA version: 9.1Level: SOCClassification code 10007541Term: Cardiac disorders
DrugsOSSIGENO LIQ 30000LT
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- COPD patients with moderate chronic stable hypoxemia and chronic heart failure.
- Sponsor
- AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
- Status
- Active, Not Recruiting
- Last Updated
- 14 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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.
Outcomes
Primary Outcomes
Not specified
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