EUCTR2005-000691-41-GB进行中（未招募）不适用
Randomised controlled trial to evaluate the effect of statins on asthma control of patients with chronic asthma. - Effect of statins on control of chronic asthma
Greater Glasgow Health Board, North Glasgow University Hospitals Division0 个研究点目标入组 52 人开始时间: 2005年3月17日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 52
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
- 性别
- All
入选标准
- •1. Asthma : This will be established symptomatically by episodic wheezing, chest tightness and/or dyspnoea and objectively confirmed by methacholine airway hyperresponsiveness or by evidence of variable airflow obstruction with an increase in FEV1 of > 12% following nebulised salbutamol (2.5mg) or diurnal peak flow variability of > 20% during the run-in period of the study
- •2.Age range 18–70 years
- •3. Duration of asthma > 1 year and on stable medication for four weeks
- •4.Receiving regular inhaled steroid treatment (British Asthma Management Guidelines: step 2 only)
- •5. Symptomatic: defined as an asthma control questionnaire score of 1 (range 0-6) prior to randomisation or use of inhaled beta2-agonist on 5 or more days in week before randomisation or FEV1 reversibility >12% or diurnal peak flow variability of >20% during the run-in period of the study
- •6. Written informed consent
- •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
- •1. Inability to demonstrate correct use of peak flow meter after instruction
- •2. Current smokers or ex-smokers of < 1 year or ex-smokers who have smoked > 5 pack years.
- •3. Asthma exacerbation 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]
- •4. Patients in whom cardiovascular risk requires statin therapy
- •5. Any known sensitivity to statin, or previous evidence of myopathy or myositis plus creatinine kinase and liver function tests 6. Non-atopic asthma
- •7. Patients who show specific IgE sensitivity or are skin test positive to grass pollen allergen will not be recruited from mid May to end of July (grass allergen season in UK)
研究者
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