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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00929734
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : October 8, 2015
Last Update Posted : October 8, 2015
Haukeland University Hospital
Information provided by (Responsible Party):
Torbjorn Omland, University Hospital, Akershus

June 26, 2009
June 29, 2009
July 9, 2015
October 8, 2015
October 8, 2015
March 2010
January 2014   (Final data collection date for primary outcome measure)
Relative Change in Reactive Hyperemia Index (RHI) [ Time Frame: Baseline to 3 months ]
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.
Peripheral vasodilator function expressed as PAT-RH ratio [ Time Frame: 3 months ]
Complete list of historical versions of study NCT00929734 on Archive Site
  • Relative Change in FEV1 [ Time Frame: Baseline to 3 months ]
  • Relative Change in High-sensitivity C-reactive Protein [ Time Frame: Baseline to 3 months ]
  • Relative Change in Interleukin 6 [ Time Frame: Baseline to 3 months ]
  • Circulatory proinflammatory markers [ Time Frame: 3 months ]
  • Leucocyte count in sputum [ Time Frame: 3 months ]
  • FEV1 and FEV1/FVC ratio [ Time Frame: 3 months ]
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Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease
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.
Not Provided
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Chronic Obstructive Pulmonary Disease (COPD)
  • Drug: Rosuvastatin
    10mg tablets, once daily in three months
    Other Name: Hydroxymethylglutaryl-CoA Reductase Inhibitor
  • Drug: Placebo
    1 tablet, once daily in three months
  • Experimental: Rosuvastatin
    Intervention: Drug: Rosuvastatin
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
January 2014
January 2014   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Torbjorn Omland, University Hospital, Akershus
University Hospital, Akershus
  • AstraZeneca
  • Haukeland University Hospital
Principal Investigator: Torbjørn Omland, PhD Akershus University Hospital, Lørenskog, Norway
University Hospital, Akershus
September 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP