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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

April 4, 2008
April 9, 2008
April 2008
March 2009   (final data collection date for primary outcome measure)
serum CRP levels [ Time Frame: 9 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00655993 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 1
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • COPD
  • Inflammation
Drug: simvastatin
40 mg po daily
  • Placebo Comparator: 1
    placebo drug
    Intervention: Drug: simvastatin
  • Active Comparator: 2
    simvastatin
    Intervention: Drug: simvastatin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
December 2009
March 2009   (final data collection date for primary outcome measure)

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.
Both
40 Years to 79 Years
No
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
United States
 
NCT00655993
00746
No
Lennard Specht, M.D., VA Loma Linda Health Care System
VA Loma Linda Health Care System
Not Provided
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
VA Loma Linda Health Care System
April 2008

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