Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease (RODEO)
This study is currently recruiting participants.
Verified April 2012 by University Hospital, Akershus
Sponsor:
University Hospital, Akershus
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: April 26, 2012
Last verified: April 2012
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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 |
|---|---|---|
|
COPD |
Drug: Rosuvastatin Drug: Placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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 University Hospital, Akershus:
Primary Outcome Measures:
- Peripheral vasodilator function expressed as PAT-RH ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Circulatory proinflammatory markers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- FEV1 and FEV1/FVC ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 140 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | March 2013 (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 |
| Genders Eligible for Study: | Both |
| 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 HMG-CoA-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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929734
Contacts
| Contact: Anke Neukamm, MD | 4741143901 | anke.neukamm@medisin.uio.no |
| Contact: Torbjørn Omland, MD, PhD | 4740107050 | torbjorn.omland@medisin.uio.no |
Locations
| Norway | |
| Akershus University Hospital | Recruiting |
| Lørenskog, Akershus, Norway, 1478 | |
| Contact: Anke Neukamm, MD 41143901 ext +47 anke.neukamm@medisin.uio.no | |
Sponsors and Collaborators
University Hospital, Akershus
AstraZeneca
Haukeland University Hospital
Investigators
| Principal Investigator: | Torbjørn Omland, PhD | Akershus University Hospital, Lørenskog, Norway |
More Information
No publications provided
| 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 |
| Last Updated: | April 26, 2012 |
| Health Authority: | Norway: Norwegian Medicines Agency Norway: Data Protection Authority |
Keywords provided by University Hospital, Akershus:
|
Inflammation Atherosclerosis Hydroxymethylglutaryl-CoA Reductase Inhibitors |
Additional relevant MeSH terms:
|
Lung Diseases Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Respiratory Tract Diseases Hydroxymethylglutaryl-CoA Reductase Inhibitors Rosuvastatin Anticholesteremic Agents |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Enzyme Inhibitors Lipid Regulating Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 19, 2013