Evaluation of Any Steroid Sparing Effect of Beta Blocker Therapy on Airway Hyper-responsiveness in Stable, Mild to Moderate Asthmatics
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Change in Histamine provocative concentration causing 20% fall in FEV1 (PC20)at 6 weeks
研究概览
简要总结
Current asthma medicines include inhalers. A common type of inhaler is called a 'beta-agonist' (e.g. salbutamol). They improve asthma symptoms by stimulating areas in the airway causing it to widen. Although these drugs are useful short term, long term use can make asthma worse in some people.
'Beta-blockers' are the complete opposite type of medication. Just now they are avoided in patients with asthma. Beta-blockers cause problems in asthmatics in the short term, including severe asthma attacks.
The other mainstay of inhaler treatment for asthma is inhaled steroid or 'preventer' medication. These work by dampening down the inflammation in the lungs that occurs in asthma.
New research has suggested that longer term use of beta-blockers can also reduce airway inflammation which may improve asthma control. This research was done in asthmatic patients who didn't need inhaled steroids to control their asthma. At the moment the investigators are studying to see if there is a benefit of beta-blocker use for asthma over and above asthmatics own usual doses of inhaled steroids.
In this study, the investigators will be trying to find out if adding a beta blocker to a smaller dose of steroid inhaler has the same effect on asthma control as just using a higher dose of steroid inhaler by itself.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Stable mild to moderate asthma
- •Histamine PC20 </= 8mg/ml
- •Receiving inhaled corticosteroid 0-1000ug daily (BDP equivalent dose)
- •FEV1 > 60% predicted
- •Diurnal variability < 30%
- •Reliever use </= 8puffs/day
- •ECG demonstrating sinus rhythm
排除标准
- •Uncontrolled symptoms of asthma
- •Systolic BP<110mmHg
- •Heart rate<60bpm
- •Pregnancy or lactation
- •Heart block
- •Heart rate limiting medications currently prescribed
- •Asthma exacerbation within 6 months of study commencement
研究组 & 干预措施
Propranolol + Low dose Qvar
干预措施: Propranolol (Drug)
Propranolol + Low dose Qvar
干预措施: Qvar 50 (Drug)
Placebo + high dose Qvar
干预措施: Placebo (Drug)
Placebo + high dose Qvar
干预措施: Qvar 100 (Drug)
结局指标
主要结局
Change in Histamine provocative concentration causing 20% fall in FEV1 (PC20)at 6 weeks
时间窗: Change from baseline to 6 weeks
Measurement of airway hyper-reactivity (a hallmark of asthma).
次要结局
- Change in resting heart rate at 6 weeks(Change from baseline to 6 weeks)
- Change in overnight urinary cortisol/creatinine ratio (OUCC) at 6 weeks(Change from baseline to 6 weeks)
- Change in symptom scores (Asthma control questionnaire and Asthma quality of life questionnaire) at 6 weeks(Change from baseline to 6 weeks)
- Change in Spirometry parameters at 6 weeks(Change from baseline to 6 weeks)
- Change in Impulse oscillometry parameters at 6 weeks(Change from baseline to 6 weeks)
- Change in exhaled tidal nitric oxide levels at 6 weeks(Change from baseline to 6 weeks)
- Change in resting blood pressure at 6 weeks(Change from baseline to 6 weeks)
研究者
William J Anderson
Clinical Research Fellow
University of Dundee
