A randomized controlled, pilot study of the effect of simvastatin, omega-3 fatty acids and antioxidants on lung function in ex-smokers with symptomatic airflow obstruction

HMRC CCRE in Respiratory and Sleep Medicine0 个研究点目标入组 40 人开始时间: 2009年5月15日最近更新: 2020年1月13日

适应症

试验速览

暂无简介。

•Ex-smokers with a smoking history of at least 10 pack-years. Ex-smokers are defined for this study as those who have stopped smoking for at least 12 months prior to Visit 1. Pack year is a term used to describe the number of cigarettes a person has smoked over time. One pack year is defined as 20 manufactured cigarettes (one pack) smoked per day for one year. For example smoking 1 1/2 packs per day for 26 years, equals 39 pack-years).
•FEV1/FVC ratio < 2 standard deviations (SD) below expected value for age, sex and height
•Age 35-60 years
•History of lower respiratory tract illness in the last 12 months OR history of chronic cough, sputum production or breathlessness in the last 12 months, AND
•C-reactive protein level greater than or equal to 3 mg/L.

•Current respiratory disorders other than chronic obstructive pulmonary disease (COPD) and asthma (e.g. lung cancer, sarcoidosis, tuberculosis, lung fibrosis, bronchiectasis)
•Subjects who have a moderate exacerbation (that required systemic corticosteroid therapy or antibiotics) of COPD in the previous month or a severe exacerbation (that required hospitalization) in the 3 months prior to baseline visit.
•Receiving long-term oral corticosteroid therapy
•Subjects who are already on statin treatment
•Allergies or intolerance to statins or one of the dietary supplements
•On any medication known to interact with statins
•Myopathies, Creatine phosphokinase (CPK) greater than 1.5 upper limits of normal.
•Active liver disease or unexplained persistent elevations of serum transaminases (> 1.5 x upper limits of normal), cholestasis
•Alcohol abuse (greater than 4 standard drinks/day)
•Renal impairment (Creatinine clearance [ClCr] < 30 mL/min)
•Hyperlipidaemia, coronary heart disease, cerebrovascular disease, peripheral vascular disease and diabetes mellitus
•Serious, uncontrolled non-respiratory disease (including serious psychological disorders) likely to interfere with the study and/or likely to cause death within the 6-month study duration.
•Participation in any other interventional research study in the last 4 weeks before baseline visit.
•Pregnant or breast-feeding women

发起方

HMRC CCRE in Respiratory and Sleep Medicine