Chronic Obstructive Pulmonary Disease (COPD)
Conditions
Interventions
Trade Name: Ranbaxy Simvastatin (generic)
Product Name: Simvastatin
Pharmaceutical Form: Over encapsulated tablet
Sponsors
University of Nottingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Male or female patients aged 45-80 years; 2) Confirmed COPD: FEV1 30-80% predicted, FEV1/FVC=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1) Known hypersensitivity to or side effects relating to previous statin treatment, or current therapy which includes a statin, ezetimibe or fibrate; 2) Clinically significant liver function abnormality; alcohol excess (defined as >21 units per week for males or 14 units for females); 3) Hypercholesterolaemia > or equal to 6.5 mmmol/L; 4) Females who are pregnant, breast feeding, or at risk of pregnancy and not using a medically acceptable form of contraception; 5) Any condition judged by investigator that would cause the study to be detrimental to patient; 6) Conditions: rheumatoid disease/other collagen vascular disease requiring therapy; diabetes mellitus; untreated hypothyroidism; inflammatory bowel disease; other respiratory disease; malignancy; documented history of IHD; cor pulmonale or known congestive heart failure; known alpha 1 antitrypsin deficiency; patients planning to undergo elective surgery during the study period. 7) Exacerbation in the last 4 weeks; 8) Significant hypoxia (PaO2 <7.3kPa); 9) Lactose intolerance 10) Therapies: oral prednisolone for more than 1 week in the last 6 months; disease modifying drugs (Gold/ sulphasalazine etc); weight losing drugs; concomitant use of warfarin and cyclosporine. Use of any investigational drug within four weeks of the baseline visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Does giving simvastatin for 6 weeks lower the risk of cardiovascular disease using arterial stiffness (a non invasive measure of risk) as an outcome, in patients with COPD? ;Secondary Objective: Does simvastatin lower inflammation in the airways and in circulation - is this related to the lowering of cardiovascular risk in patients with COPD? ;Primary end point(s): Change in Arterial Stiffness with 6 weeks of simvastatin compared to placebo. | — |
Countries
United Kingdom
Outcome results
None listed