The effect of simvastatin, omega-3 fatty acids and antioxidants on lung function in ex-smokers with symptomatic airflow obstructio
- Conditions
- airflow obstructionRespiratory - Chronic obstructive pulmonary disease
- Registration Number
- ACTRN12609000272291
- Lead Sponsor
- HMRC CCRE in Respiratory and Sleep Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Stopped early
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ung function: forced expiratory volume in 1 second (FEV1), forced vital capacity (FVC) and FEV1/FVC ratio measured by spirometry[at baseline and at 6, 12 and 24 weeks after intervention commencement];high-sensitivity C-Reactive Protein (hs-CRP) in blood sample[at baseline and at 6, 12 and 24 weeks after intervention commencement]
- Secondary Outcome Measures
Name Time Method Exhaled nitric oxide, measured in a breath test (this involves blowing air into a mouthpiece attached to a machine that measures levels of the gas in each breath)[at baseline and at 6,12 and 24 weeks after intervention commencement];sputum %neutrophils and sputum Interleukin-8 (IL-8), examined with microsopic cytology examination of sputum[at baseline and at 6, 12 and 24 weeks after intervention commencement];Respiratory-related quality of life: St George Respiratory Questionnaire (SGRQ)[at baseline and at 6, 12 and 24 weeks after intervention commencement];Generic quality of life: SF-36 health survey[at baseline and at 6, 12 and 24 weeks after intervention commencement];Exercise capacity, measured by endurance test on a bicycle at 80% of individual peak work capacity[at baseline and at 24 weeks after intervention commencement]