EUCTR2006-003103-39-GB进行中（未招募）1 期
Effect of statins on asthma control and airway inflammation in smokers with asthma - Effect of statins in smokers with asthma
niversity of Glasgow & Greater Glasgow Health Board0 个研究点目标入组 110 人开始时间: 2008年2月20日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 110
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •Inclusion criteria
- •1.Diagnosis of asthma: This will be established symptomatically by episodic wheezing, chest tightness and/or dyspnoea and objectively confirmed by
- •methacholine airway hyperresponsiveness < 8mg/ml or evidence of variable airflow obstruction with an increase in FEV1 of > 12% following nebulised salbutamol (2.5mg) or diurnal peak flow variability of > 20% in a week during the run-in period of the study. This is calculated using the morning peak flow readings over a week using the formula Min%/Max); GINA guidelines 2006.
- •2.Age range 18-60 years
- •3.Duration of asthma > 1 year and either on stable medication for 4 weeks or weaned from medication according to protocol.
- •4.Symptomatic; defined as an asthma control questionnaire score of 1 (range 0-6) prior to randomisation (using complete 7 question score) or
- •use of inhaled beta2-agonist on 3 or more days in the week before randomisation or
- •FEV1 reversibility >12% or diurnal peak flow variability of > 20% during the run-in period of the study.
- •5.Smoking asthmatics will be defined as current cigarette smokers who have a > 5 pack year smoking history.
- •6.No other medication for their asthma other than a short-acting bronchodilator (step 1 British Asthma Guidelines).
- •7.Adjustment of asthma medication to BTS guidelines if required.
- •If subjects are stable and on long acting bronchodilators (LABA) and/or inhaled corticosteroids (up to 2000 mcg of beclometasone), an attempt will be made to carefully wean them off this medication over 4-6 weeks.
- •COPD: Pilot Sub Study
- •1. Age range 40-80 years
- •2. Diagnosis of COPD as defined by GOLD guidelines
- •Mild COPD: FEV1/FVC < 70%; FEV1 = 80% predicted;
- •Moderate COPD: FEV1/FVC < 70% and FEV1 50 - 79% predicted
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Exclusion criteria
- •1.Ex-smokers or never smokers
- •2.Patients with unstable asthma; defined as the presence of 1 or more of the following events in the month prior to randomisation [Emergency/out of hours’ visit of patients to the GP; GP visit to patient at home; A & E hospital attendance; hospital admission]
- •3.Patients on statin therapy
- •4.Any known sensitivity or adverse reaction to statin, or previous evidence of myopathy or myositis plus creatine kinase and liver function tests > x2 upper limit of normal range. If elevated creatine kinase is possibly due to vigorous exercise, then it will be repeated after a week. If elevated, the patient will not be included in the study.
- •5.Patients who have a definite history of seasonal worsening of asthma will not be recruited during that season, eg. grass pollen season.
- •6.Patients who require medications known to interact with statins, such as azole antifungal agents, erythromycin, clarithromycin, cyclosporine, gemfibrozil, verapamil and amiodarone.
- •7.Patients who require other asthma medication such as leukotriene receptor antagonists or theophyllines.
- •8.Unable to understand or unwilling to sign the consent form.
- •9.Pregnancy, planned pregnancy in the next 6 months and lactation.
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