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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lactose tablet | Placebo Comparator |
| |
| Simvastatin 20mg | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Simvastatin | Drug | Simvastatin 20mg once daily (in the evening) for 6 weeks |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in arterial stiffness as measured by aortic pulse wave velocity (PWV) over study period | Aortic Pulse wave velocity (Sphygmocor, Atcor) | Week 0 (start) and week 6 (end) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Circulating Inflammatory Mediators over study period | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nottingham Respiratory Biomedical Research Unit | Nottingham | NG5 1PB | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25673981 | Derived | John ME, Cockcroft JR, McKeever TM, Coward WR, Shale DJ, Johnson SR, Thornton JG, Harrison TW, Knox AJ, Bolton CE. Cardiovascular and inflammatory effects of simvastatin therapy in patients with COPD: a randomized controlled trial. Int J Chron Obstruct Pulmon Dis. 2015 Jan 29;10:211-21. doi: 10.2147/COPD.S76061. eCollection 2015. |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D019821 | Simvastatin |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D008148 | Lovastatin |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
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| Lactose tablet |
| Drug |
One tablet taken each evening for 6 weeks |
|
| week 0 (start) and week 6 (end) |
| Change in blood total cholesterol, triglycerides, HDL and LDL over study period | week 0 (Start) and week 6 (End) |
| Change in airway inflammatory markers (differential cell count, exhaled nitric oxide and airway cytokines) over study period | week 0 and week 6 |
| Change in lung function: Spirometry - forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) | week 0 (Start) and week 6 (End) |
| Change on blood pressure over study period | Week 0 (start) and Week 6 (end) |
| Change in Liver function tests | Week 0 (start) and Week 6 (End) |
| Change in creatine phosphokinase (CPK) over study period | Week 0 (start) and Week 6(End) |
| Change in Handgrip strength over study period | Week 0 (start) and Week 6 (end) |
| Change in blood desmosine over study period | Week 0 (Start) and Week 6 (end) |
| Change in circulating matrix metalloproteinase over study period | Week 0 (start) and Week 6 (end) |
| Baseline arterial stiffness (aortic pulse wave velocity) | Week 0 |
| Baseline airway (differential cell count, exhaled nitric oxide and cytokines)and circulating inflammatory status (cytokines) | Week 0 |
| Baseline matrix metalloproteinase in airway and blood | Week 0 |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
| D000073893 | Sugars |