PATIENTS AFFECTED BY COPD MedDRA version: 9.1 Level: SOC Classification code 10038738
Conditions
Interventions
Trade Name: NAPRILENE
Pharmaceutical Form: Tablet
INN or Proposed INN: ENALAPRIL MALEATO
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 5-
Pharmaceutical form of
Sponsors
PROF. ALFREDO CHETTA
Eligibility
Sex/Gender
All
Inclusion criteria
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 20 pack years); 5. Written informed consent obtained Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) no 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: 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 β-blockers, tricyclic antidepressants or monoamine oxidase inhibitors; 10. Patients requiring long-term oxygen therapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: To assess the effect of the long term treatment with Enalapril versus placebo on quality of life and breathlessness perception of COPD patients;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 | — |
Countries
Italy
Outcome results
None listed