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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-04-30

Study Completion Date

2014-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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COPD Inflammation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

placebo drug

Group Type PLACEBO_COMPARATOR

simvastatin

Intervention Type DRUG

40 mg po daily

2

simvastatin

Group Type ACTIVE_COMPARATOR

simvastatin

Intervention Type DRUG

40 mg po daily

Interventions

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simvastatin

40 mg po daily

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No