Effect of an ACE inhibitor on the exercise capacity of COPD patients. A randomized double-blind placebo-controlled study - Effect of an ACE inhibitor on the exercise capacity of COPD patients
- Conditions
- PATIENTS AFFECTED BY COPDMedDRA version: 9.1Level: SOCClassification code 10038738
- Registration Number
- EUCTR2009-009074-27-IT
- Lead Sponsor
- PROF. ALFREDO CHETTA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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 ≥ 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
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
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method