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临床试验/EUCTR2009-009074-27-IT
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 &#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
  • 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 &#946;-blockers, tricyclic antidepressants or monoamine oxidase inhibitors; 10. Patients requiring long-term oxygen therapy

研究者

发起方
PROF. ALFREDO CHETTA

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