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

University Hospital, Akershus

Status and phase

Completed

Phase 2

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Treatments

Drug: Rosuvastatin

Drug: Placebo

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00929734

2009A2

Details and patient eligibility

About

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.

Enrollment

99 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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