Simvastatin Therapy for Moderate and Severe COPD (STATCOPE)
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| ClinicalTrials.gov Identifier: NCT01061671 |
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Recruitment Status :
Terminated
(Futility)
First Posted : February 3, 2010
Results First Posted : March 26, 2015
Last Update Posted : January 2, 2018
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Sponsor:
University of Minnesota
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
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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 |
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 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
Drug Information available for:
Simvastatin
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: simvastatin
40 mgms of simvastatin daily
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Drug: simvastatin
40 mgms of simvastatin daily
Other Name: Zocor |
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Placebo Comparator: placebo
Matched placebo pill daily
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Drug: Placebo
Matched placebo pill daily
Other Name: sugar pill |
Primary Outcome Measures :
- Rates of COPD Exacerbations [ Time Frame: up to 37 months ]
Secondary Outcome Measures :
- Time to First COPD Exacerbation [ Time Frame: up to 37 months ]
- Change in FEV1 (% Pred) From Baseline to Last Measure [ Time Frame: Baseline, last measure at up to 37 months ]
- Acute Exacerbation COPD Hospitalization Rates (Events/Patient Year) [ Time Frame: up to 37 months ]
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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:
- Male and female subjects, 40-80 years of age.
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Clinical diagnosis of at least moderate COPD as defined by the GOLD criteria:
- Postbronchodilator FEV1(forced expiratory volume at one second)/FVC(forced vital capacity) < 70%,
- Postbronchodilator FEV1 (forced expiratory volume at one second) < 80% predicted, with or without chronic symptoms (i.e., cough, sputum production).
- Cigarette consumption of 10 pack-years or more. Patients may or may not be active smokers.
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Must meet one or more of the following 4 conditions
- Be using supplemental oxygenate
- Receiving a course of systemic corticosteroids and/or antibiotics for respiratory problems in the past year,
- Visiting an Emergency Department for a COPD exacerbation within the past year, or
- Being hospitalized for a COPD (Chronic Obstructive Pulmonary Disease) exacerbation within the past year
- Willingness to make return visits and availability by telephone for duration of study.
- Free of active coronary disease
- Subject with expected life expectancy > 36 months
Exclusion Criteria:
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Patients who:
- are on statin drugs.
- should be on statins based on established risk stratification using the ATP-III (Adult Treatment Panel) to determine 10 year risk.
- 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.
- A diagnosis of asthma.
- 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.
- Special patient groups: prisoners, pregnant women, institutionalized patients
- 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.
- Woman using estradiol compounds for contraception. Postmenopausal women on estradiol compounds for hormone replacement therapy will be allowed into the trial.
- Participants otherwise meeting the inclusion criteria will not be enrolled until they are a minimum of four weeks from their most recent acute exacerbation.
- A clinical diagnosis of bronchiectasis defined as production of > one-half cup of purulent sputum/day.
- 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
- 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.
- Patients with renal failure defined by serum creatinine greater than 3mg/dl.
- 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.
- 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.
- Participants drinking greater than 4 cups (1qt) of grapefruit juice per day.
- Participants drinking greater than 3 cups of green tea per day.
- 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.
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
Show 51 study locations
Sponsors and Collaborators
University of Minnesota
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
Ottawa Hospital Research Institute
Investigators
| 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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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:
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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 |