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临床试验/NCT01544634
NCT01544634已完成2 期

Evaluation of Any Steroid Sparing Effect of Beta Blocker Therapy on Airway Hyper-responsiveness in Stable, Mild to Moderate Asthmatics

University of Dundee1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2012年4月4日最近更新:
适应症
干预措施
相关药物

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

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

Experimental

干预措施: Propranolol (Drug)

Propranolol + Low dose Qvar

Experimental

干预措施: Qvar 50 (Drug)

Placebo + high dose Qvar

Active Comparator

干预措施: Placebo (Drug)

Placebo + high dose Qvar

Active Comparator

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

William J Anderson

Clinical Research Fellow

University of Dundee

研究点 (1)

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