ACTRN12609000272291
Terminated
Phase 3
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 sites40 target enrollmentMay 15, 2009
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- airflow obstruction
- Sponsor
- HMRC CCRE in Respiratory and Sleep Medicine
- Enrollment
- 40
- Status
- Terminated
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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