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Simvastatin Therapy for Moderate and Severe COPD (STATCOPE)

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ClinicalTrials.gov Identifier: NCT01061671
Recruitment Status : Terminated (Futility)
First Posted : February 3, 2010
Results First Posted : March 26, 2015
Last Update Posted : January 2, 2018
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief Summary:
To determine the effect of daily administration of 40 mgms simvastatin taken for at least 12 months (range 12-36 months) on the frequency of exacerbations of chronic obstructive lung disease (COPD) in patients with moderate to severe COPD who are prone to exacerbations and do not have other indications for statin treatment.

Condition or disease Intervention/treatment Phase
Pulmonary Disease, Chronic Obstructive Drug: simvastatin Drug: Placebo Phase 3

Detailed Description:
COPD exacerbation is a common complication that significantly contributes to the high morbidity, mortality and costs associated with COPD. COPD exacerbations are associated with heightened lung inflammation that may have systemic implications (e.g., peripheral muscle weakness, cognitive impairment, depression, stroke, acute coronary syndrome, and atherosclerosis). Statins are potent agents that significantly reduce vascular events in patients with increased risks due to prior cardiac or cerebral vascular events and elevated lipid profiles. Statins have pleiotropic effects that extend well beyond their lipid lowering effects and may be potent anti-inflammatory agents. Retrospective data conducted in COPD patients indicate that statin use is associated with markedly decreased rates of COPD hospitalization and stabilization of lung function. Decreases in mortality in COPD due to complications of flu-like illnesses and deaths due to cardiovascular events have also been reported. Inflammatory biomarkers (C-reactive protein and interleukin- 6) are reported to be elevated in moderate to severe COPD patients who are prone to exacerbations. Inflammatory biomarkers (C-reactive protein and interleukin- 6) are reported to be reduced by statin therapy in patients with hyperlipidemia and cardiovascular diseases. Treatments that can effectively lessen the prevalence and severity of COPD exacerbations are desperately needed
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 885 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Prospective Randomized Placebo-Controlled Trial of SimvaSTATin in the Prevention of COPD Exacerbations (STATCOPE)
Study Start Date : March 2010
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases
Drug Information available for: Simvastatin

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: simvastatin
40 mgms of simvastatin daily
 Drug: simvastatin
40 mgms of simvastatin daily
Other Name: Zocor
Placebo Comparator: placebo
Matched placebo pill daily
 Drug: Placebo
Matched placebo pill daily
Other Name: sugar pill


Outcome Measures
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Primary Outcome Measures :
  1. Rates of COPD Exacerbations [ Time Frame: up to 37 months ]

Secondary Outcome Measures :
  1. Time to First COPD Exacerbation [ Time Frame: up to 37 months ]
  2. Change in FEV1 (% Pred) From Baseline to Last Measure [ Time Frame: Baseline, last measure at up to 37 months ]
  3. Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year) [ Time Frame: up to 37 months ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male and female subjects, 40-80 years of age.

  2. Clinical diagnosis of at least moderate COPD as defined by the GOLD criteria:

    1. Postbronchodilator FEV1(forced expiratory volume at one second)/FVC(forced vital capacity) < 70%,
    2. Postbronchodilator FEV1 (forced expiratory volume at one second) < 80% predicted, with or without chronic symptoms (i.e., cough, sputum production).
  3. Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers.

  4. Must meet one or more of the following 4 conditions

    1. Be using supplemental oxygenate
    2. Receiving a course of systemic corticosteroids and/or antibiotics for respiratory problems in the past year,
    3. Visiting an Emergency Department for a COPD exacerbation within the past year, or
    4. Being hospitalized for a COPD (Chronic Obstructive Pulmonary Disease) exacerbation within the past year
  5. Willingness to make return visits and availability by telephone for duration of study.
  6. Free of active coronary disease
  7. Subject with expected life expectancy > 36 months

Exclusion Criteria:

  1. Patients who:

    1. are on statin drugs.
    2. should be on statins based on established risk stratification using the ATP-III (Adult Treatment Panel) to determine 10 year risk.
  2. Documented history of active coronary heart disease, such as unstable angina, prior myocardial infarction, stroke, symptomatic peripheral vascular or carotid artery disease, or congestive heart failure within the past 3 months.
  3. A diagnosis of asthma.
  4. The presence of a diagnosis other than COPD that results in the patient being either medically unstable, or having a predicted life expectancy < 3 years.
  5. Special patient groups: prisoners, pregnant women, institutionalized patients
  6. Women who are at risk of becoming pregnant during the study (pre-menopausal) and who refuse to use acceptable birth control (hormone-based oral or barrier contraceptive) for the duration of the study.
  7. Woman using estradiol compounds for contraception. Postmenopausal women on estradiol compounds for hormone replacement therapy will be allowed into the trial.
  8. Participants otherwise meeting the inclusion criteria will not be enrolled until they are a minimum of four weeks from their most recent acute exacerbation.
  9. A clinical diagnosis of bronchiectasis defined as production of > one-half cup of purulent sputum/day.
  10. Participants using niacin, azole antifungals (itraconazole, ketoconazole, posaconazole), fibric acid derivatives, erythromycin, clarithromycin, telithromycin, diltiazem, amlodipine , ranolazine,HIV protease inhibitors (such as indinavir), amiodarone, gemfibrozil, cyclosporine, verapamil, danazol, nefazodone, and red yeast rice extracts are excluded
  11. Active liver disease. Active liver disease is defined as ALT (alanine aminotransferase), AST (aspartate aminotransferase) as greater than 1.5 times the upper limit of normal.
  12. Patients with renal failure defined by serum creatinine greater than 3mg/dl.
  13. Alcoholism. Alcoholism is defined as > 35 drinks per week. A drink is defined as one bottle of beer, one 8-ounce glass of wine, or one ounce of hard liquor.
  14. Hypersensitivity to HMG CoA (3-hydroxy-3-methylglutaryl-coenzyme A) reductase inhibitors. Hypersensitivity is defined as an allergic reaction to statin, prior history of myopathy, rhabdomyolysis or previous intolerance to statin use.
  15. Participants drinking greater than 4 cups (1qt) of grapefruit juice per day.
  16. Participants drinking greater than 3 cups of green tea per day.
  17. Diabetics will be excluded. Diabetics are defined by:

1. A CURRENT physician diagnosis of diabetes OR 2. CURRENT use of diabetic meds OR 3. Elevated HbA1c > 6.5% 18. The discretion of the Principal Investigator that the potential participant will not be a reliable study subject to complete the study requirements.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01061671


Locations
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Sponsors and Collaborators
University of Minnesota
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: John E Connett, PhD University of Minnesota (Data Coordinating Center)
Principal Investigator: Steven M Scharf, MD, PhD University of Maryland, Baltimore
Principal Investigator: Mark Dransfield, MD University of Alabama at Birmingham
Principal Investigator: George Washko, MD Brigham and Women's Hospital Boston
Principal Investigator: Richard K Albert, MD Denver Health Medical Center
Principal Investigator: Richard Casaburi, MD, PhD Harbor-UCLA Research & Education Institute
Principal Investigator: Dennis E Niewoehner, MD Minnesota Veterans Affairs Medical Center
Principal Investigator: Gerard J Criner, MD Temple University Philadelphia
Principal Investigator: Frank Sciurba, MD University of Pittsburgh
Principal Investigator: Stephen C Lazarus, MD University of California at San Francisco
Principal Investigator: Fernando J Martinez, MD University of Michigan
Principal Investigator: Don Sin, M.D. St. Paul's Hospital
Principal Investigator: Shawn Aaron, M.D. The Ottawa Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT01061671    
Other Study ID Numbers: 689
U10HL074424 ( U.S. NIH Grant/Contract )
First Posted: February 3, 2010    Key Record Dates
Results First Posted: March 26, 2015
Last Update Posted: January 2, 2018
Last Verified: December 2017
Keywords provided by University of Minnesota:
Chronic Obstructive Pulmonary Disease
COPD
Exacerbation
Lung function
 Cardiovascular
Smoking
Statins
Simvastatin
Additional relevant MeSH terms:
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Lung Diseases
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Lung Diseases, Obstructive
Simvastatin
Anticholesteremic Agents
 Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors