NCT01365286已完成4 期
Heart Rate Lowering Efficacy and Respiratory Safety of Ivabradine in Patients With Obstructive Airway Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Heart rate
研究概览
简要总结
The purpose of this study is to investigate heart rate lowering efficacy and respiratory safety of ivabradine in patients with asthma and COPD.
详细描述
In this double blind, placebo-controlled, crossover study, 20 asthmatics and 20 COPD patients received ivabradine 7,5 mg b.i.d. and placebo for 5 days in crossover manner. HR in ECG holter monitoring, peak expiratory flow rate (PEFR), symptoms, rescue medication consumption and AEs were evaluated in both periods of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •documented diagnosis of asthma or COPD in accordance with guidelines
- •stable condition, defined as a disease without exacerbation for at least 1 month prior to study enrolment
- •mean HR in holter ECG recording of ≥ 60 bpm
排除标准
- •disease exacerbation in previous month
- •inability to understand instructions on study procedures
研究组 & 干预措施
Ivabradine-Placebo
Active Comparator
干预措施: Ivabradine (Procoralan) (Drug)
Placebo-Ivabradine
Active Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Heart rate
时间窗: Change from baseline in heart rate during 5-day ivabradine and 5-day placebo treatment (24-hour ECG monitoring on the 3rd day)
Difference in mean heart rate during ivabradine and placebo treatment
次要结局
- Peak expiratory flow rate (PEFR)(Everyday measurement of morning and evening PEFR during 5-day ivabradine and 5-day placebo treatment)
- Symptoms(Everyday symptom scoring during 5 day ivabradine and 5-day placebo treatment)
- Rescue medication(Everyday rescue medication usage assessments during 5-day ivabradine and 5-day placebo treatment)
- Number of participants with adverse events (AEs)(Number of patients with AEs evaluated throughout the study (5-day ivabradine and 5 day placebo treatment))
研究者
研究点 (1)
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