ISRCTN05581879已完成未知
Angiotensin converting enzyme (ACE) inhibition and mechanisms of skeletal muscle weakness in chronic obstructive pulmonary disease (COPD): a double-blind, randomised, placebo-controlled, parallel trial
Imperial College London (UK)0 个研究点目标入组 80 人开始时间: 2008年10月31日最近更新:
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 发起方
- 入组人数
- 80
研究概览
简要总结
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24556825
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Adult patients (greater than 18 years, either sex) with COPD diagnosed according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria. Only patients with quadriceps weakness will be enrolled into this randomised controlled trial (RCT).
排除标准
- •1. Clinically unstable patients (within one month of exacerbation)
- •2. Those with a permanent pacemaker (which is a contraindication to magnetic stimulation), or significant co-morbidity
- •3. Patients with an accepted indication for ACE inhibition (left ventricular dysfunction, diabetes) or a contraindication such as renovascular disease
- •4. Creatinine clearance (estimated) less than 50 ml/min
- •5. Hypotension
- •6. Use of anticoagulants (contraindication to biopsy) or angiotensin converting enzyme inhibitor (ACE-I) or angiotensin II (ATII) receptor antagonists
- •7. Allergy to ACE-I
- •8. Pregnancy
- •9. Patients who have participated in a pulmonary rehabilitation programme within the past three months
研究者
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Angiotensin Converting Enzyme Inhibitor (ACE) Induced AngioedemaBERINERTRandomized, double-blind, two arms, multicenter, Phase III study of Berinert for treatment of ACE induced AngioedemaAngiotensin – Converting – Enzyme – Inhibitors (ACEi) are used in the treatment of several types of cardiovascular and renal diseases. A known side effect of ACEi are angioedema of the head and neck region. These can lead to severe dyspnoea and the need for intubation and are thought to be bradykinin mediated. Up until now there is no study-evaluated conservative therapeutic concept for the treatment of these patients.MedDRA version: 18.1Level: HLTClassification code 10002425Term: AngioedemasSystem Organ Class: 100000004870EUCTR2012-001670-28-DEMedizinische Fakultät der Technischen Universität München52