COPD patients with moderate chronic stable hypoxemia and chronic heart failure. MedDRA version: 9.1 Level: SOC Classification code 10038738 Term: Respiratory, thoracic and mediastinal disorders MedDRA version: 9.1 Level: SOC Classification code 10007541 Term: Cardiac disorders
Conditions
Interventions
Trade Name: OSSIGENO LIQ 30000LT
Pharmaceutical Form: Inhalation gas
INN or Proposed INN: Oxygen
Concentration unit: l litre(s)
Concentration type: equal
Concentration number: 873-
Sponsors
AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
Eligibility
Sex/Gender
All
Inclusion 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 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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Italy
Outcome results
None listed