Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: January 29, 2014
Last verified: January 2014

June 26, 2009
January 29, 2014
March 2010
January 2014   (final data collection date for primary outcome measure)
Peripheral vasodilator function expressed as PAT-RH ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00929734 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Circulatory proinflammatory markers [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Leucocyte count in sputum [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • FEV1 and FEV1/FVC ratio [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
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 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
Both
40 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00929734
2009A2
Yes
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
January 2014

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