Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether rosuvastatin improves measures of endothelial function, decreases measures of inflammation, and improves pulmonary function in patients with stable chronic obstructive pulmonary disease.

Official Title
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Effect of ROsuvastatin Therapy on Peripheral Vasodilator Function, Inflammatory Markers and Pulmonary Function in Patients With StablE Chronic Obstructive Pulmonary Disease

Conditions
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Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
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* Drug: Rosuvastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Stable COPD patients of both genders with no COPD exacerbations less than three weeks prior to inclusion COPD stage I to IV after the GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease) Age between 40 and 80 years Exclusion criteria: Diagnosed lung disease other than COPD, except chronic asthmatic bronchitis and mild bronchiectasis without or few physical signs (diagnosed by high resolution CT) History of or active coronary artery disease (CAD), cerebrovascular or peripheral vascular disease History of or clinically significant congestive heart failure, valvular heart disease, clinically significant arrhythmias or conduction delays History of uncontrolled arterial hypertension (defined as blood pressure above180/110 mmHg with or without the use of antihypertensive medication) Body mass index >40kg/m2 History of diabetes mellitus, measured fasting glucose > 11 mmol/L History of Hypercholesterolemia, measured total cholesterol > 8 mmol/L Known poliomyelitis, motor neurone disease, cranial or temporal arteritis, stroke or myopathy Neutropenia, anemia (Hb < 8 g/100mL) History of chronic renal failure, serum creatinine > 176 micromol/L (2.0mg/dL) Creatine kinase > 3 times the upper limit of normal (ULN) Acute or chronic liver disease (serum transaminases > 3 times the ULN) Pregnancy (oral examination and blood test prior to inclusion) Active abuse of drugs or alcohol, poor compliance anticipated Statin use within the last 4 weeks prior to study start or previously clear indication for statin use Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another hydroxymethylglutaryl-Coenzyme A-reductase inhibitor incl. Rosuvastatin History of malignant disease of any kind within 5 years prior to inclusion. History of uncontrolled hypothyroidism Participation in another pharmaceutical or medical device clinical trial study less than 4 weeks prior inclusion. Use concomitant of medications that are known to interact with Crestor. This includes the following medications: Warfarin and other coumarin (vitamin K antagonist) anticoagulants, Cyclosporin, Gemfibrozil and Antacid

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br> | Drug: Rosuvastatin<br>* 10mg tablets, once daily in three months<br>* Other names: Hydroxymethylglutaryl-CoA Reductase Inhibitor;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* 1 tablet, once daily in three months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Change in Reactive Hyperemia Index (RHI) | Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment. | Baseline to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Change in FEV1 |  | Baseline to 3 months | 
| Relative Change in High-sensitivity C-reactive Protein |  | Baseline to 3 months | 
| Relative Change in Interleukin 6 |  | Baseline to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammation, Atherosclerosis, Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors