Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease (COPD)
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Rosuvastatin; Placebo
Intervention description: 10mg tablets, once daily in three months; 1 tablet, once daily in three months
Intervention MeSH terms: Rosuvastatin Calcium; Hydroxymethylglutaryl-CoA Reductase Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 40 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Inflammation; Atherosclerosis; Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors

Summary:

      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.
    

Eligibility criteria:

        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