Skip to main content
OpenTrials
Completed

NCT Number: NCT00929734

Effect of Rosuvastatin Therapy 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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rosuvastatin

Drug

10mg tablets, once daily in three months

Other names: Hydroxymethylglutaryl-CoA Reductase Inhibitor

Placebo

Drug

1 tablet, once daily in three months

Primary outcomes

  1. 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.

Secondary outcomes

  1. Relative Change in FEV1

    Time frame: Baseline to 3 months

  2. Relative Change in High-sensitivity C-reactive Protein

    Time frame: Baseline to 3 months

  3. Relative Change in Interleukin 6

    Time frame: Baseline to 3 months

Sponsors and collaborators

Lead sponsor

University Hospital, Akershus

Other

Collaborators

  • AstraZeneca
  • Haukeland University Hospital

Registry information

Official study title

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

Acronym: RODEO

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Jun 29, 2009
Registry last updated
Oct 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.