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

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

Study Overview

• Status: Completed
• Conditions: Inflammation; COPD
• Intervention / Treatment: Drug: simvastatin

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92357
      • VA Loma Linda Health Care System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 79 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 1; placebo drug	Drug: simvastatin; 40 mg po daily
Active Comparator: 2; simvastatin	Drug: simvastatin; 40 mg po daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
serum CRP levels	9 weeks

Collaborators and Investigators

• Sponsor: VA Loma Linda Health Care System
• Investigators: Principal Investigator: Lennard Specht, M.D., VA Loma Linda Health Care System; Principal Investigator: Hemal J. Parekh, M.D., VA Loma Linda Healthcare System; Principal Investigator: James D. Anholm, M.D., VA Loma Linda Healthcare System

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2008
• Primary Completion (Actual): March 1, 2009
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: April 4, 2008
• First Submitted That Met QC Criteria: April 9, 2008
• First Posted (Estimate): April 10, 2008

Study Record Updates

• Last Update Posted (Actual): April 26, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Inflammation; COPD; simvastatin; CRP levels
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antimetabolites; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Simvastatin
• Other Study ID Numbers: 00746

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO