Evaluation of Beta Blockers for the Treatment of Asthma. A Randomised Controlled Trial of Propranolol
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics.
研究概览
简要总结
Current asthma medicines include inhalers. A common inhaler used in asthma is called a beta-agonist (for example salbutamol). They improve asthma symptoms by stimulating areas in the human airway resulting in widening of the human airway. Although these drugs are useful after the first dose, longterm use can cause worsening asthma symptoms.
Beta-blockers are the complete opposite type of medication. Just now they are avoided in patients with asthma as after the first dose they can cause airway narrowing and cause an asthma attack.
New research has suggested that long term use of beta-blockers can reduce airway inflammation which can improve asthma control and improve symptoms.
This research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. What the investigators want to do is see if the same benefit of beta-blocker use is asthma can be seen in people who take inhaled steroids.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female volunteers with stable mild intermittent or mild persistent asthma.
- •Stable defined as: FEV1 (Forced Expiratory Volume in 1second) >80% predicted with diurnal FEV1 variation <30% when LABA (Long Acting Beta Agonist) washed out.
- •Methacholine PC20 <4mg/ml.
- •Ability to perform spirometry, IOS (Impulse Oscillometry), bronchial challenge and all domiciliary measurements.
- •Ability to obtain Informed consent.
- •Mild to Moderate Asthmatics taking ≤1000μg BDP (Beclomethasone Diproprionate) per day or equivalent.
- •Withhold LABAs for 1 week prior to study.
排除标准
- •Uncontrolled symptoms of asthma.
- •Resting BP (Blood Pressure) <110 systolic or HR (Heart Rate)<
- •Pregnancy or lactation.
- •Known or suspected sensitivity to the IMP (Investigational Medicinal Product)(s).
- •Inability to comply with protocol.
- •Any degree of heart block.
- •Rate limiting medication including β blockers, rate limiting Calcium - Channel Blockers and Amiodarone.
- •Any other clinically significant medical condition that may either endanger the health or safety of the participant, or jeopardise the protocol.
- •An asthma exacerbation within the last 6 months.
研究组 & 干预措施
Propranolol
Chronic dose escalation of propranolol over period of 6 to 8 weeks.
干预措施: propranolol (Drug)
Placebo
Matched placebo used for dose escalation period of 6 to 8 weeks
干预措施: placebo (Drug)
结局指标
主要结局
To establish effects of chronic dosing with 'beta-blockers' on airway tone and hyperreactivity in mild asthmatics.
时间窗: 6 weeks
次要结局
未报告次要终点
研究者
Brian J Lipworth
Professor
University of Dundee