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

Primary Purpose

COPD, Inflammation

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

simvastatin

About this trial

This is an interventional treatment trial for COPD focused on measuring COPD, Inflammation, CRP levels, simvastatin

Eligibility Criteria

40 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

VA Loma Linda Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Arm Description

placebo drug

simvastatin

Outcomes

Primary Outcome Measures

serum CRP levels

Secondary Outcome Measures

Full Information

NCT ID

NCT00655993

First Posted

April 4, 2008

Last Updated

April 24, 2023

Sponsor

VA Loma Linda Health Care System

1. Study Identification

Unique Protocol Identification Number

NCT00655993

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Completed

Study Start Date

April 2008 (Actual)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

VA Loma Linda Health Care System

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD, Inflammation

Keywords

COPD, Inflammation, CRP levels, simvastatin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Description

placebo drug

Arm Title

Arm Type

Active Comparator

Arm Description

simvastatin

Intervention Type

Drug

Intervention Name(s)

simvastatin

Intervention Description

40 mg po daily

Primary Outcome Measure Information:

Title

serum CRP levels

Time Frame

9 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

79 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Lennard Specht, M.D.

Organizational Affiliation

VA Loma Linda Health Care System

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Hemal J. Parekh, M.D.

Organizational Affiliation

VA Loma LInda Healthcare System

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

James D. Anholm, M.D.

Organizational Affiliation

VA Loma Linda Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Loma Linda Health Care System

City

Loma Linda

State/Province

California

ZIP/Postal Code

92357

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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