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
Results First Received: July 9, 2015  
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
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: Rosuvastatin
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Rosuvastatin Rosuvastatin: 10mg tablets, once daily in three months
Placebo Placebo: 1 tablet, once daily in three months

Participant Flow:   Overall Study
    Rosuvastatin     Placebo  
STARTED     49     50  
COMPLETED     47     47  
NOT COMPLETED     2     3  
Lost to Follow-up                 2                 1  
Withdrawal by Subject                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Complete case population

Reporting Groups
  Description
Rosuvastatin Rosuvastatin 10mg tablet
Placebo Placebo tablet
Total Total of all reporting groups

Baseline Measures
    Rosuvastatin     Placebo     Total  
Number of Participants  
[units: participants]
  47     47     94  
Age  
[units: years]
Mean (Standard Deviation)
  66  (5.5)     63  (6.6)     65  (6.1)  
Gender  
[units: participants]
     
Female     21     24     45  
Male     26     23     49  
BMI  
[units: kg/m^2]
Mean (Standard Deviation)
  23  (3.8)     24  (4.1)     24  (3.9)  
Systolic blood pressure  
[units: mmHg]
Mean (Standard Deviation)
  131  (17.7)     135  (20.1)     133  (18.9)  
Diastolic blood pressure  
[units: mmHg]
Mean (Standard Deviation)
  79  (8.4)     80  (10.3)     80  (9.4)  
Heart rate  
[units: beats/min]
Mean (Standard Deviation)
  68  (11.2)     67  (10.9)     67  (11.0)  
History of hypertension  
[units: participants]
     
Yes     12     11     23  
No     35     36     71  
History of asthma  
[units: participants]
     
Yes     9     13     22  
No     38     34     72  
Pack-years [1]
[units: pack-years]
Mean (Standard Deviation)
  39  (16.1)     35  (15.5)     37  (15.8)  
Current smoking  
[units: participants]
     
Yes     12     23     35  
No     35     24     59  
Haemoglobin  
[units: g/dl]
Mean (Standard Deviation)
  14.1  (1.4)     14.0  (0.2)     14.0  (1.2)  
Estimated Glomerular Filtration Rate (eGFR) [2]
[units: ml/min]
Mean (Standard Deviation)
  82.4  (19.6)     90.1  (29.4)     86.2  (25.1)  
Leucocyte count  
[units: cells*10^9/L]
Mean (Standard Deviation)
  6.6  (1.4)     6.9  (1.7)     6.7  (1.6)  
High-sensitivity C-reactive protein [3]
[units: mg/L]
Median (Inter-Quartile Range)
  1.4   (0.8 to 3.7)     1.8   (1.0 to 4.4)     1.7   (0.8 to 3.8)  
Interleukin 6  
[units: pg/mL]
Median (Inter-Quartile Range)
  4.1   (2.9 to 5.3)     3.4   (2.7 to 4.7)     3.7   (2.7 to 5.1)  
Glucose  
[units: mmol/L]
Mean (Standard Deviation)
  5.0  (0.6)     5.1  (0.7)     5.0  (0.6)  
Cholesterol  
[units: mmol/L]
Mean (Standard Deviation)
  5.5  (0.9)     5.7  (1.1)     5.6  (1.0)  
LDL-C  
[units: mmol/L]
Mean (Standard Deviation)
  3.3  (0.8)     3.5  (0.9)     3.4  (0.9)  
HDL-C  
[units: mmol/L]
Mean (Standard Deviation)
  1.8  (0.1)     1.8  (0.1)     1.8  (0.5)  
Triglycerides  
[units: mmol/L]
Mean (Standard Deviation)
  1.0  (0.4)     1.1  (0.5)     1.1  (0.4)  
Forced expiratory volume at one second (FEV1)  
[units: Liter]
Mean (Standard Deviation)
  1.4  (0.6)     1.5  (0.7)     1.4  (0.6)  
FEV1, % of predicted  
[units: Percent predicted value]
Mean (Standard Deviation)
  48.3  (18.9)     52.1  (18.8)     50.2  (18.9)  
FEV1/FVC [4]
[units: Percent of FVC]
Mean (Standard Deviation)
  47  (13.8)     49  (11.8)     48  (12.8)  
Antihypertensive treatment  
[units: participants]
     
Yes     12     10     22  
No     35     37     72  
Inhaled corticosteroids [5]
[units: participants]
     
Yes     36     34     70  
No     11     13     24  
Long acting beta agonists  
[units: participants]
     
Yes     2     3     5  
No     45     44     89  
Long acting muscarinic antagonists  
[units: participants]
     
Yes     30     27     57  
No     17     20     37  
Anti-inflammatory treatment  
[units: participants]
     
Yes     2     0     2  
No     45     47     92  
Oestrogen treatment  
[units: participants]
     
Yes     4     3     7  
No     43     44     87  
[1] Number of packs of cigarettes smoked per day by the number of years the person has smoked
[2] Renal function as calculated by the Cockcroft-Gault formula ((140- age) × bodyweight/serum creatinine) (× 0.85 for women))
[3] Acute-phase reactant used in cardiovascular risk assessment
[4] Forced vital capacity (FVC)
[5] including long acting beta agonists (LABA)



  Outcome Measures
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1.  Primary:   Relative Change in Reactive Hyperemia Index (RHI)   [ Time Frame: Baseline to 3 months ]

2.  Secondary:   Relative Change in FEV1   [ Time Frame: Baseline to 3 months ]

3.  Secondary:   Relative Change in High-sensitivity C-reactive Protein   [ Time Frame: Baseline to 3 months ]

4.  Secondary:   Relative Change in Interleukin 6   [ Time Frame: Baseline to 3 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Professor Torbjørn Omland
Organization: University of Oslo
phone: +47 40107050
e-mail: torbjorn.omland@medisin.uio.no



Responsible Party: Torbjorn Omland, 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
Health Authority: Norway: Norwegian Medicines Agency
Norway: Data Protection Authority