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

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ClinicalTrials.gov Identifier: NCT00655993
Recruitment Status : Unknown
Verified April 2008 by VA Loma Linda Health Care System.
Recruitment status was:  Recruiting
First Posted : April 10, 2008
Last Update Posted : April 10, 2008
Sponsor:
Information provided by:
VA Loma Linda Health Care System

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

Condition or disease Intervention/treatment Phase
COPD Inflammation Drug: simvastatin Phase 1

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Statin Therapy on C-Reactive Protein Levels in Patients With COPD
Study Start Date : April 2008
Estimated Primary Completion Date : March 2009
Estimated Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Simvastatin

Arms and Interventions
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Arm Intervention/treatment
Placebo Comparator: 1
placebo drug
 Drug: simvastatin
40 mg po daily
Active Comparator: 2
simvastatin
 Drug: simvastatin
40 mg po daily


Outcome Measures
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Primary Outcome Measures :
  1. serum CRP levels [ Time Frame: 9 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00655993


Contacts
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Contact: Hemal J. Parekh, M.D. 909-825-7084 ext 6098 hemalp6@yahoo.com
Contact: Lennard Specht, M.D. 909-825-7084 ext 6098 norman.specht@va.gov

Locations
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United States, California
VA Loma Linda Health Care System Recruiting
Loma Linda, California, United States, 92357
Contact: Lennard Specht, M.D.    909-825-7084 ext 6098    norman.specht@va.gov   
Contact: James Anholm, M.D.    909-825-7084 ext 6098    james.anholm@va.gov   
Sponsors and Collaborators
VA Loma Linda Health Care System
Investigators
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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
More Information
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Responsible Party: Lennard Specht, M.D., VA Loma Linda Health Care System
ClinicalTrials.gov Identifier: NCT00655993     History of Changes
Other Study ID Numbers: 00746
First Posted: April 10, 2008    Key Record Dates
Last Update Posted: April 10, 2008
Last Verified: April 2008
Keywords provided by VA Loma Linda Health Care System:
COPD
Inflammation
CRP levels
simvastatin
Additional relevant MeSH terms:
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Inflammation
Pathologic Processes
Simvastatin
Anticholesteremic Agents
Hypolipidemic Agents
 Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors