Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by VA Loma Linda Health Care System.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
VA Loma Linda Health Care System
ClinicalTrials.gov Identifier:
NCT00655993
First received: April 4, 2008
Last updated: April 9, 2008
Last verified: April 2008
  Purpose

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


Condition Intervention Phase
COPD
Inflammation
Drug: simvastatin
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Statin Therapy on C-Reactive Protein Levels in Patients With COPD

Resource links provided by NLM:


Further study details as provided by VA Loma Linda Health Care System:

Primary Outcome Measures:
  • serum CRP levels [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: April 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: 1
placebo drug
Drug: simvastatin
40 mg po daily
Active Comparator: 2
simvastatin
Drug: simvastatin
40 mg po daily

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.

  Eligibility

Ages Eligible for Study:   40 Years to 79 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00655993

Contacts
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
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
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

No publications provided

Responsible Party: Lennard Specht, M.D., VA Loma Linda Health Care System
ClinicalTrials.gov Identifier: NCT00655993     History of Changes
Other Study ID Numbers: 00746
Study First Received: April 4, 2008
Last Updated: April 9, 2008
Health Authority: United States: Federal Government

Keywords provided by VA Loma Linda Health Care System:
COPD
Inflammation
CRP levels
simvastatin

Additional relevant MeSH terms:
Pulmonary Disease, Chronic Obstructive
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Inflammation
Pathologic Processes
Simvastatin
Anticholesteremic Agents
Antimetabolites
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014