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
Recruitment status was Recruiting
Sponsor:
VA Loma Linda Health Care System
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
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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
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:
|
Inflammation Pulmonary Disease, Chronic Obstructive Lung Diseases, Obstructive Pathologic Processes Lung Diseases Respiratory Tract Diseases Simvastatin Hypolipidemic Agents |
Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Lipid Regulating Agents Therapeutic Uses Hydroxymethylglutaryl-CoA Reductase Inhibitors Anticholesteremic Agents Enzyme Inhibitors |
ClinicalTrials.gov processed this record on May 19, 2013