Effect of Statins on Asthma Control and Airway Inflammation in Smokers With Asthma: a Randomised Controlled Double-blind Parallel Group Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 71
- 试验地点
- 1
- 主要终点
- Change in peak flow data
研究概览
简要总结
Asthma is a chronic inflammatory condition of the lungs.
There is evidence that cigarette smoking can make asthma symptoms worse and that smokers with asthma do not respond as well to standard therapies as non-smokers.
Statins are drugs which are already used to lower cholesterol. They have also been shown to have some anti-inflammatory properties.
In this trial the investigators will give a randomised group of smokers Atorvastatin and the remaining group a placebo or blank tablet. The investigators will then monitor patients' responses in terms of peak flow data, symptom diaries, questionnaires and breathing tests.
详细描述
Despite several studies, which have shown that smokers with asthma have more severe symptoms, accelerated decline in lung function and diminished response to treatment with inhaled and oral corticosteroids, more than 25% of asthmatics continue to smoke. Smoking cessation advice is often ineffective.
Statins are used as cholesterol lowering agents, however, there is now also evidence that they have additional anti-inflammatory effects which may be useful in treatment of smokers with asthma.
This is a randomised placebo controlled double-blind parallel group study.
Following screening to assess suitability for the study, patients will be randomised to treatment with either Atorvastatin 40mg or placebo (blank tablet)for 8 weeks.
After 4 weeks of treatment, all patients will be commenced on a low dose inhaled corticosteroid for the remainder of the study to assess whether treatment with statins can overcome steroid resistance in smokers with asthma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of asthma for more than 1 year
- •Symptomatic asthma
- •Smoker with greater than 5 pack year history
- •On short acting bronchodilator only- although may have medication weaned if stable
排除标准
- •Ex-smokers or non-smokers
- •Patients already on statin therapy
- •Unstable asthma
- •Previous statin sensitivity or myopathy or myositis
- •On any medications known to interact with statins
- •Note separate entry criteria for pilot study of COPD patients
研究组 & 干预措施
2
Atorvastatin 40
干预措施: atorvastatin (Drug)
placebo
matched placebo
干预措施: matched placebo (Drug)
结局指标
主要结局
Change in peak flow data
时间窗: 4 weeks
次要结局
- sputum cell counts(4 weeks and 8 weeks)
- spirometry(4 weeks and 8 weeks)
- airway responsiveness to methacholine(4 weeks and 8 weeks)
- symptom scores(4 weeks and 8 weeks)
- Exhaled and alveolar NO(4 weeks and 8 weeks)
- Exacerbation rates(4 and 8 weeks)
- immunological tests in blood(4 and 8 weeks)
- ACQ score(4 and 8 weeks)
- AQLQ score(4 and 8 weeks)
- Safety issues(4 and 8 weeks)
研究者
Neil Thomson
Professor of Respiratory Medicine
NHS Greater Clyde and Glasgow