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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00655993
Enrollment
30
Registered
2008-04-10
Start date
2008-04-30
Completion date
2014-08-31
Last updated
2023-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Inflammation

Keywords

COPD, Inflammation, CRP levels, simvastatin

Brief summary

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

Detailed 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.

Interventions

DRUGsimvastatin

40 mg po daily

Sponsors

VA Loma Linda Health Care System
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 79 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
serum CRP levels9 weeks

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026