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

Conditions: MedDRA version: 9.1Level: SOCClassification code 10007541Term: Cardiac disorders
COPD patients with moderate chronic stable hypoxemia and chronic heart failure.
MedDRA version: 9.1Level: SOCClassification code 10038738Term: Respiratory, thoracic and mediastinal disorders

Registration Number: EUCTR2008-001136-12-IT

Lead Sponsor: AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The main goal of the study is to investigate whether, in COPD patients with chronic heart failure and moderate chronic hypoxemia (55 < PaO2 < 65 mmHg), the appropriate medical treatment without LTOT is not inferior to medical treatment with LTOT in terms of survival. Therefore the primary outcome of the study is mortality.;Secondary Objective: Secondary end point of the study is to evaluate whether the appropriate medical treatment without LTOT is not inferior to medical treatment with LTOT in terms of quality of life, rate and severity of exacerbation, number of hospital admissions.;Primary end point(s): The main outcome of the study will be the incidence of mortality.

Secondary Outcome Measures