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OpenTrials
Completed

NCT Number: NCT00655993

Effect of Statin Therapy on C-reactive Protein Levels in Patients With Chronic Obstructive Lung Disease (COPD)

Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in COPD patients.

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Key information

Age range

40 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

VA Loma Linda Health Care System

Loma Linda, California, 92357, United States

About this study

Patients with chronic obstructive lung disease (COPD) have an ongoing systemic inflammation, which can be assessed by measuring C-reactive protein (CRP). CRP is found to be a strong and independent predictor of future COPD outcomes. Statins are a class of cholesterol lowering drugs that decrease mortality from cardiovascular disease and stroke. In addition, they have anti-inflammatory, anti-thrombotic and immunomodulatory properties. Statins lower C-reactive protein by the ability to reduce the production of interleukin (IL)-6, the cytokine that activates the acute phase CRP response.

Thus the rationale for this study is to evaluate effect of statins on the levels of CRP and ET-1 in COPD patients.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Medically optimized COPD patients
  • Age 40-79 years.
  • serum CRP levels >3mg/l

Exclusion criteria

  • Current smoker
  • COPD exacerbation in the last 2 months.
  • Active hepatic or severe renal dysfunction.
  • connective tissue disease, chronic inflammatory disease, malignancy, any acute illness, leukocytosis (>10,000 white blood cells) or thrombocytosis (>450,000 platelets).
  • Recent h/o myocardial infarction, angina in the last 6 months.
  • Pregnancy.

Treatment and study plan

simvastatin

Drug

40 mg po daily

Primary outcomes

  1. serum CRP levels

    Time frame: 9 weeks

Sponsors and collaborators

Lead sponsor

VA Loma Linda Health Care System

Fed

Registry information

Official study title

Effect of Statin Therapy on C-reactive Protein Levels in Patients With COPD

Important dates

Study start
2008
Primary completion
2009
Study completion
2014
First posted
Apr 10, 2008
Registry last updated
Apr 26, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.