E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
PATIENTS AFFECTED BY COPD |
|
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.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess in COPD patients with limb muscle deterioration and without both cardiovascular disease and contraindications to ACE-inhibitors, whether or not long term treatment with Enalapril, as compared to placebo, can improve exercise capacity and limb muscle strength, as a consequence of its effect on muscle fibres |
|
E.2.2 | Secondary objectives of the trial |
To assess the effect of the long term treatment with Enalapril versus placebo on quality of life and breathlessness perception of COPD patients |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Patients of either sex aged > 65 years; 2. Clinically stable patients with a diagnosis of severe COPD and satisfying the following: FEV1/SVC ratio < 70%, post-bronchodilator FEV1 < 50% of the predicted and Total Lung Capacity &#8805; 120% of the predicted; 3. Positive partial response to the reversibility test in the screening visit, defined as an increase from baseline value of at least 5% (but less than 12%) of FEV1 value measured 30 minutes after 400 µg) of inhaled Salbutamol;4. Current or past tobacco heavy smoking habits (defined as smoking for > 20 pack years); 5. Written informed consent obtained |
|
E.4 | Principal exclusion criteria |
1. COPD exacerbation; 2. History or presence of clinically significant disease whose sequelae and/or treatments can interfere with the results of the present study; 3. Bronchial asthma; 4 Chronic heart failure documented by an echocardiography, coronary artery disease, cardiac arrhythmias and systemic hypertension; 5. History of percutaneous transluminal coronary angioplasty or coronary artery by-pass graft ; 6. Impaired hepatic and/or renal function; 7. Evidence of posture and gait disturbances, or impairment of limb coordination due to any cause; 8. History of hypersensitivity to ACE inhibitor drugs; 9. Patients taking &#946;-blockers, tricyclic antidepressants or monoamine oxidase inhibitors; 10. Patients requiring long-term oxygen therapy |
|
E.5 End points |
E.5.1 | Primary end point(s) |
: 1. Increase of limb and respiratory muscle strength and improvement of exercise capacity in terms of both maximal oxygen uptake and maximal workload and 6 minute walking distance; 2. Change of type 2a and 2b to type 1 muscle fibres |
|
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 | Yes |
E.6.5 | Efficacy | Yes |
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 | No |
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) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
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 | Yes |
E.8.2.3 | Other | No |
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 | 2 |
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 | No |
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 | 2 |
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 | 2 |
E.8.9.2 | In all countries concerned by the trial months | 0 |