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

This study has been completed.
Sponsor:
Collaborators:
AstraZeneca
Haukeland University Hospital
Information provided by (Responsible Party):
Torbjorn Omland, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT00929734
First received: June 26, 2009
Last updated: September 7, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention Phase
Chronic Obstructive Pulmonary Disease (COPD) Drug: Rosuvastatin Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of ROsuvastatin Therapy on Peripheral Vasodilator Function, Inflammatory Markers and Pulmonary Function in Patients With StablE Chronic Obstructive Pulmonary Disease

Resource links provided by NLM:


Further study details as provided by Torbjorn Omland, University Hospital, Akershus:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 99
Study Start Date: March 2010
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rosuvastatin Drug: Rosuvastatin
10mg tablets, once daily in three months
Other Name: Hydroxymethylglutaryl-CoA Reductase Inhibitor
Placebo Comparator: Placebo Drug: Placebo
1 tablet, once daily in three months

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00929734

Locations
Norway
Akershus University Hospital
Lørenskog, Akershus, Norway, 1478
Sponsors and Collaborators
University Hospital, Akershus
AstraZeneca
Haukeland University Hospital
Investigators
Principal Investigator: Torbjørn Omland, PhD Akershus University Hospital, Lørenskog, Norway
  More Information

Responsible Party: Torbjorn Omland, Professor of Medicine, University Hospital, Akershus
ClinicalTrials.gov Identifier: NCT00929734     History of Changes
Other Study ID Numbers: 2009A2
Study First Received: June 26, 2009
Results First Received: July 9, 2015
Last Updated: September 7, 2015

Keywords provided by Torbjorn Omland, University Hospital, Akershus:
Inflammation
Atherosclerosis
Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Rosuvastatin Calcium
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents

ClinicalTrials.gov processed this record on August 22, 2017