A Study of Simvastatin Therapy for Moderate and Severe COPD

Overview

About this study

The purpose of this study is to determine the effects of daily simvastatin, 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Male or female
  • Age 40-80 years
  • 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
    • May or may not be active smokers
  • Must meet one or more of the following 4 conditions
    • Requires the use of supplemental oxygen
    • Received a course of systemic corticosteroids and/or antibiotics for respiratory problems in the past year
    • Visited an Emergency Department for a COPD exacerbation within the past year
    • Was hospitalized for a COPD (Chronic Obstructive Pulmonary Disease) exacerbation within the past year
  • Willing to make return visits and available by telephone for the duration of the study
  • Free of active coronary disease
  • Life expectancy > 36 months

Exclusion Criteria

  • 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 either medical instability, or of having a predicted life expectancy < 3 years
  • Vulnerable patient such as prisoners, pregnant women, or institutionalized patient
  • At risk of becoming pregnant during the study (pre-menopausal) and refuses to use acceptable birth control (hormone-based oral or barrier contraceptive) for the duration of the study
  • Using estradiol compounds for contraception
    • Postmenopausal 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
  • 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
  • Active liver disease defined as ALT (alanine aminotransferase) and AST (aspartate aminotransferase)  greater than 1.5 times the upper limit of normal
  • Renal failure defined by serum creatinine greater than 3mg/dl
  • Alcoholism 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, an allergic reaction to statin, prior history of myopathy, rhabdomyolysis or previous intolerance to statin use
  • Drink greater than 4 cups (1qt) of grapefruit juice per day
  • Drink greater than 3 cups of green tea per day
  • Diabetic, defined by
    • A current physician diagnosis of diabetes 
    • Current use of diabetic meds 
    • Elevated HbA1c > 6.5%
  • It is at the discretion of the Principal Investigator if the potential participant will not be a reliable study subject to complete the study requirements

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Rochester, Minn.

Mayo Clinic principal investigator

Paul Scanlon, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20312130

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