NCT00288548Unknown4 期
Pulmonary Effects of the Combination of Metoprolol and Formoterol in COPD
Martini Hospital Groningen2 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2006年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Difference in airway reactivity after treatment with metoprolol compared to placebo.
研究概览
简要总结
We want to study the effect of the combination of metoprolol (a beta-blocker) with formoterol (a beta-agonist) on long function in patients with Chronic Obstructive Pulmonary Disease (COPD). There are more and more clues that a beta-blocker, when well chosen and in the right dosage, won't harm the long function in patients with COPD. Since a beta-blocker can be a valuable addition to treating patients with heart problems we would like to see if this category of medication can be available for COPD patients in the future.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •male/female aged between 40-70 inclusive
- •COPD defined by GOLD criteria
- •FEV1 greater or equal to 60% of predicted without medication
- •baseline FEV1 greater or equal than 1.2L
- •10 or more pack years
- •no hard contraindications for use of beta blockers
- •being able to perform technically acceptable pulmonary function tests
- •signed informed consent
- •systolic blood pressure equal to 130 or greater
排除标准
- •instable COPD during the month before visit 1
- •usage of corticosteroids during the month before visit 1
- •significant pulmonary diseases other than COPD
- •a history of cancer within the last 5 years (basal cell carcinoma or cutaneous squamous cell carcinoma allowed)
- •a recent history of myocardial infarction
- •use of an investigational drug within one month or six half lives (which ever is greater) of visit 1
- •contra-indications for the use of ipratropium-bromide
结局指标
主要结局
Difference in airway reactivity after treatment with metoprolol compared to placebo.
次要结局
- Effect of formoterol on airway reactivity comparing metoprolol with placebo.
- Borg-scores during provocation test
- Peak-flow measurements
- CCQ-scores
- Exacerbation rate and rescue medication use
研究者
研究点 (2)
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