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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE April 4, 2008
First Posted Date  ICMJE April 10, 2008
Last Update Posted Date April 10, 2008
Study Start Date  ICMJE April 2008
Estimated Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2008)
serum CRP levels [ Time Frame: 9 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Statin Therapy on C-Reactive Protein Levels in Patients With Chronic Obstructive Lung Disease (COPD)
Official Title  ICMJE Effect of Statin Therapy on C-Reactive Protein Levels in Patients With COPD
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • COPD
  • Inflammation
Intervention  ICMJE Drug: simvastatin
40 mg po daily
Study Arms  ICMJE
  • Placebo Comparator: 1
    placebo drug
    Intervention: Drug: simvastatin
  • Active Comparator: 2
    simvastatin
    Intervention: Drug: simvastatin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: April 9, 2008)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2009
Estimated Primary Completion Date March 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 79 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00655993
Other Study ID Numbers  ICMJE 00746
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lennard Specht, M.D., VA Loma Linda Health Care System
Study Sponsor  ICMJE VA Loma Linda Health Care System
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account VA Loma Linda Health Care System
Verification Date April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP