E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COPD patients with moderate chronic stable hypoxemia and chronic heart failure. |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10038738 |
E.1.2 | Term | Respiratory, thoracic and mediastinal disorders |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | SOC |
E.1.2 | Classification code | 10007541 |
E.1.2 | Term | Cardiac disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The main outcome of the study will be the incidence of mortality. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
la terapia medica ottimale senza LTOT non sia inferiore alla terapia medica ottimale con LTOT |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 75 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |