Chronic obstructive pulmonary disease (COPD) is a condition of the lungs which results in breathing difficulties due to the lungs becoming inflamed and the airways narrowed. Current treatments have focused on opening up the narrowed airways but, in addition, we know there is increased inflammation in the blood and these patients are at increased risk of heart disease. Statins, simvastatin being one of them, are drugs used to lower cholesterol in the blood but may also reduce inflammation and lower the risk of heart disease. This study will explore whether simvastatin reduces one of the risk factors in patients with COPD in a short term proof of principle study. The key purpose is to determine whether simvastatin improves the pressure and stiffness of the main blood vessels namely the arterial stiffness measure of aortic pulse wave velocity (PWV). In parallel, we will describe changes in airways and / or blood inflammation and change in breathing ability
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
70
Simvastatin 20mg once daily (in the evening) for 6 weeks
One tablet taken each evening for 6 weeks
Nottingham Respiratory Biomedical Research Unit
Nottingham, United Kingdom
Change in arterial stiffness as measured by aortic pulse wave velocity (PWV) over study period
Aortic Pulse wave velocity (Sphygmocor, Atcor)
Time frame: Week 0 (start) and week 6 (end)
Change in Circulating Inflammatory Mediators over study period
Time frame: Week 0 (Start) and week 6 (End)
Change in distance (metres)walked on 6 minute walking test
together with pre- and post-walk oxygen saturations
Time frame: week 0 (start) and week 6 (end)
Change in blood total cholesterol, triglycerides, HDL and LDL over study period
Time frame: week 0 (Start) and week 6 (End)
Change in airway inflammatory markers (differential cell count, exhaled nitric oxide and airway cytokines) over study period
Time frame: week 0 and week 6
Change in lung function: Spirometry - forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC)
Time frame: week 0 (Start) and week 6 (End)
Change on blood pressure over study period
Time frame: Week 0 (start) and Week 6 (end)
Change in Liver function tests
Time frame: Week 0 (start) and Week 6 (End)
Change in creatine phosphokinase (CPK) over study period
Time frame: Week 0 (start) and Week 6(End)
Change in Handgrip strength over study period
Time frame: Week 0 (start) and Week 6 (end)
Change in blood desmosine over study period
Time frame: Week 0 (Start) and Week 6 (end)
Change in circulating matrix metalloproteinase over study period
Time frame: Week 0 (start) and Week 6 (end)
Baseline arterial stiffness (aortic pulse wave velocity)
Time frame: Week 0
Baseline airway (differential cell count, exhaled nitric oxide and cytokines)and circulating inflammatory status (cytokines)
Time frame: Week 0
Baseline matrix metalloproteinase in airway and blood
Time frame: Week 0
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