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NCT00655993 Clinical Trial

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

COPD Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00655993
Other study ID # 00746
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date April 2008
Est. completion date August 2014

Study information
Verified date April 2023
Source VA Loma Linda Health Care System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date August 2014
Est. primary completion date March 2009
Accepts healthy volunteers No
Gender All
Age group 40 Years to 79 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• simvastatin
40 mg po daily

Locations
Country Name City State
United States VA Loma Linda Health Care System Loma Linda California

Sponsors (1)
Lead Sponsor Collaborator
VA Loma Linda Health Care System

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary serum CRP levels 9 weeks
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