Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease (RODEO)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Completed
Phase
Phase 2
Locations
Norway
Study Type
Interventional
Intervention
Rosuvastatin
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Inflammation, Atherosclerosis, Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors
Eligibility 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
Sites / Locations
- Akershus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Rosuvastatin
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Relative Change in FEV1
Relative Change in High-sensitivity C-reactive Protein
Relative Change in Interleukin 6
Full Information
NCT ID
NCT00929734
First Posted
June 26, 2009
Last Updated
September 7, 2015
Sponsor
University Hospital, Akershus
Collaborators
AstraZeneca, Haukeland University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00929734
Brief Title
Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease
Acronym
RODEO
Official Title
Effect of ROsuvastatin Therapy on Peripheral Vasodilator Function, Inflammatory Markers and Pulmonary Function in Patients With StablE Chronic Obstructive Pulmonary Disease
Study Type
Interventional
2. Study Status
Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
AstraZeneca, Haukeland University Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Inflammation, Atherosclerosis, Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rosuvastatin
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rosuvastatin
Other Intervention Name(s)
Hydroxymethylglutaryl-CoA Reductase Inhibitor
Intervention Description
10mg tablets, once daily in three months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1 tablet, once daily in three months
Primary Outcome Measure Information:
Title
Relative Change in Reactive Hyperemia Index (RHI)
Description
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.
Time Frame
Baseline to 3 months
Secondary Outcome Measure Information:
Title
Relative Change in FEV1
Time Frame
Baseline to 3 months
Title
Relative Change in High-sensitivity C-reactive Protein
Time Frame
Baseline to 3 months
Title
Relative Change in Interleukin 6
Time Frame
Baseline to 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Torbjørn Omland, PhD
Organizational Affiliation
Akershus University Hospital, Lørenskog, Norway
Official's Role
Principal Investigator
Facility Information:
Facility Name
Akershus University Hospital
City
Lørenskog
State/Province
Akershus
ZIP/Postal Code
1478
Country
Norway
12. IPD Sharing Statement
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Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease
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