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| Sponsor: | National Heart, Lung, and Blood Institute (NHLBI) |
|---|---|
| Information provided by (Responsible Party): | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT01061671 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Pulmonary Disease, Chronic Obstructive |
Drug: simvastatin Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Prospective Randomized Placebo-Controlled Trial of SimvaSTATin in the Prevention of COPD Exacerbations (STATCOPE) |
| Estimated Enrollment: | 1126 |
| Study Start Date: | March 2010 |
| Estimated Study Completion Date: | April 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
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
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Clinical diagnosis of at least moderate COPD as defined by the GOLD criteria:
Must meet one or more of the following 4 conditions
Exclusion Criteria:
Patients who:
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
Show 48 Study Locations| Principal Investigator: | John E Connett, PhD | University of Minnesota (Data Coordinating Center) |
| Principal Investigator: | Steven M Scharf, MD, PhD | University of Maryland |
| 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
| Responsible Party: | National Heart, Lung, and Blood Institute (NHLBI) |
| ClinicalTrials.gov Identifier: | NCT01061671 History of Changes |
| Other Study ID Numbers: | 689, U10HL074424 |
| Study First Received: | February 2, 2010 |
| Last Updated: | April 23, 2012 |
| Health Authority: | United States: Federal Government |
|
Chronic Obstructive Pulmonary Disease COPD Exacerbation Lung function |
Cardiovascular Smoking Statins Simvastatin |
|
Chronic Disease Lung Diseases Respiration Disorders Pulmonary Disease, Chronic Obstructive Disease Attributes Pathologic Processes Respiratory Tract Diseases Lung Diseases, Obstructive Simvastatin |
Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |