EUCTR2009-009074-27-IT进行中(未招募)不适用
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
PROF. ALFREDO CHETTA0 个研究点开始时间: 2009年3月16日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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
排除标准
- •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
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