EUCTR2017-001507-76-SE进行中（未招募）1 期
Beta-blockeRs tO patieNts with CHronIc Obstructive puLmonary diseasE (BRONCHIOLE)A pragmatic clinical trial with partial registry-based follow-up
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,700
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
- •A diagnosis of COPD confirmed by spirometry showing post bronchodilator value of Forced Expiratory Volume in one second (FEV1)//Forced Vital Capacity (FVC) < 70 according to the Global Initiative on Obstructive Pulmonary Disease (GOLD), and with a history of tobacco smoking or occupational/environmental exposure for smoke gas or dust
- •- =40 years of age.
- •- Sinus rhythm =50/min and <120 at inclusion.
- •- Written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 600
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1100
排除标准
- •- Known hypersensitivity to metoprolol or related derivatives.
- •- AF or other arrhythmias for which beta blockers are indicated according to
- •the investigator discretion.
- •- AV block II or III unless treated with a pacemaker.
- •- Sinus bradycardia (resting heart rate <50/min).
- •- Sick sinus syndrome unless treated with a pacemaker.
- •- Clinical signs of or a previous diagnosis of HF.
- •- Systolic blood pressure <90 mmHg.
- •- Severe bronchial asthma.
- •- Current beta-blocker treatment.
- •- Inability to provide informed consent.
- •- Age below 40 years.
- •- Acute on-going exacerbation of COPD.
- •- Previous randomization in the BRONCHIOLE trial.
研究者
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