Simvastatin Therapy for Moderate and Severe COPD

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.

Conditions

• Pulmonary Disease, Chronic Obstructive

Interventions

DRUG

simvastatin

40 mgms of simvastatin daily

DRUG

Placebo

Matched placebo pill daily

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

  collaborator NIH

• Canadian Institutes of Health Research (CIHR)

  collaborator OTHER_GOV

• Ottawa Hospital Research Institute

  collaborator OTHER

• University of Minnesota

  lead OTHER

Principal Investigators

• John E Connett, PhD · University of Minnesota (Data Coordinating Center)

• Steven M Scharf, MD, PhD · University of Maryland, Baltimore

• Mark Dransfield, MD · University of Alabama at Birmingham

• George Washko, MD · Brigham and Women's Hospital Boston

• Richard K Albert, MD · Denver Health Medical Center

• Richard Casaburi, MD, PhD · Harbor-UCLA Research & Education Institute

• Dennis E Niewoehner, MD · Minnesota Veterans Affairs Medical Center

• Gerard J Criner, MD · Temple University Philadelphia

• Frank Sciurba, MD · University of Pittsburgh

• Stephen C Lazarus, MD · University of California at San Francisco

• Fernando J Martinez, MD · University of Michigan

• Don Sin, M.D. · St. Paul's Hospital

• Shawn Aaron, M.D. · The Ottawa Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2014-01-31

Completion

2014-01-31

Countries

• United States
• Canada

Study Locations