Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2026-03-22 @ 3:04 PM
Study NCT ID:
NCT00655993
Status:
COMPLETED
Last Update Posted:
2023-04-26
First Post:
2008-04-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Statin Therapy on C-reactive Protein Levels in Patients With Chronic Obstructive Lung Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-24', 'studyFirstSubmitDate': '2008-04-04', 'studyFirstSubmitQcDate': '2008-04-09', 'lastUpdatePostDateStruct': {'date': '2023-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-04-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serum CRP levels', 'timeFrame': '9 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD', 'Inflammation', 'CRP levels', 'simvastatin'], 'conditions': ['COPD', 'Inflammation']}, 'descriptionModule': {'briefSummary': 'Hypothesis for this pilot study is that simvastatin will lower the levels of CRP and ET-1 in COPD patients.', 'detailedDescription': '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.\n\nThus the rationale for this study is to evaluate effect of statins on the levels of CRP and ET-1 in COPD patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medically optimized COPD patients\n* Age 40-79 years.\n* serum CRP levels \\>3mg/l\n\nExclusion Criteria:\n\n* Current smoker\n* COPD exacerbation in the last 2 months.\n* Active hepatic or severe renal dysfunction.\n* connective tissue disease, chronic inflammatory disease, malignancy, any acute illness, leukocytosis (\\>10,000 white blood cells) or thrombocytosis (\\>450,000 platelets).\n* Recent h/o myocardial infarction, angina in the last 6 months.\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT00655993', 'briefTitle': 'Effect of Statin Therapy on C-reactive Protein Levels in Patients With Chronic Obstructive Lung Disease (COPD)', 'organization': {'class': 'FED', 'fullName': 'VA Loma Linda Health Care System'}, 'officialTitle': 'Effect of Statin Therapy on C-reactive Protein Levels in Patients With COPD', 'orgStudyIdInfo': {'id': '00746'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'description': 'placebo drug', 'interventionNames': ['Drug: simvastatin']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'simvastatin', 'interventionNames': ['Drug: simvastatin']}], 'interventions': [{'name': 'simvastatin', 'type': 'DRUG', 'description': '40 mg po daily', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92357', 'city': 'Loma Linda', 'state': 'California', 'country': 'United States', 'facility': 'VA Loma Linda Health Care System', 'geoPoint': {'lat': 34.04835, 'lon': -117.26115}}], 'overallOfficials': [{'name': 'Lennard Specht, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Loma Linda Health Care System'}, {'name': 'Hemal J. Parekh, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Loma LInda Healthcare System'}, {'name': 'James D. Anholm, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'VA Loma Linda Healthcare System'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'VA Loma Linda Health Care System', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'James D. Anholm, M.D.', 'investigatorAffiliation': 'VA Loma Linda Health Care System'}}}}