Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— RODEOOfficial title:
Effect of ROsuvastatin Therapy on Peripheral Vasodilator Function, Inflammatory Markers and Pulmonary Function in Patients With StablE Chronic Obstructive Pulmonary Disease
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.
Status | Completed |
Enrollment | 99 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Akershus University Hospital | Lørenskog | Akershus |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Akershus | AstraZeneca, Haukeland University Hospital |
Norway,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
Secondary | Relative Change in FEV1 | Baseline to 3 months | No | |
Secondary | Relative Change in High-sensitivity C-reactive Protein | Baseline to 3 months | No | |
Secondary | Relative Change in Interleukin 6 | Baseline to 3 months | No |
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