Ignite Creation Date:
2025-12-25 @ 2:26 AM
Ignite Modification Date:
2025-12-27 @ 11:13 PM
Study NCT ID:
NCT01266434
Status:
COMPLETED
Last Update Posted:
2016-03-16
First Post:
2010-12-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-03-15', 'studyFirstSubmitDate': '2010-12-22', 'studyFirstSubmitQcDate': '2010-12-23', 'lastUpdatePostDateStruct': {'date': '2016-03-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sputum eosinophils', 'timeFrame': '8 weeks', 'description': 'To determine the additive effect of simvastatin on airway inflammation in ICS-treated patients with persistent asthma by measuring eosinophil counts in induced sputum and on lung function (FEV1)'}], 'secondaryOutcomes': [{'measure': 'Phosphorylated p38 MAPK in sputum cells', 'timeFrame': '8 weeks', 'description': '1. To determine the additional effects of simvastatin in combination with inhaled corticosteroids on the expression of phosphorylated p38 MAPK and phosphorylated activating transcription factor (ATF)2 in induced sputum cells from asthmatic patients.\n2. To confirm the above in vivo results in the in vitro model using monocyte-derived dendritic cells.\n3. To determine the effects of simvastatin and/or corticosteroids on Th2 cytokine production by peripheral blood CD4+ T-lymphocytes in vitro.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['moderate persistent asthma', 'Inhaled corticosteroids'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'To test whether simvastatin has an additional anti-inflammatory effects on p38 MAPK, a signaling molecule for inflammation in inhaled steroid-treated asthmatics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* mild-to-moderate persistent asthmatics\n* FEV1 = OR \\> 50% of predicted\n\nExclusion Criteria:\n\n* Previous history of renal disease or serum creatinine is more than 2 mg/dl.\n* Previous history of liver disease.\n* Pregnancy or lactation.\n* Are already receiving or are known to be allergic to statins or to have developed myositis.\n* Have an asthma exacerbation requiring treatment with oral corticosteroids during the 3 months prior to the commencement of study entry.\n* Being treated with immunosuppressive agents.\n* Unwilling to cooperate the study.'}, 'identificationModule': {'nctId': 'NCT01266434', 'acronym': 'Simvastatin', 'briefTitle': 'The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma', 'organization': {'class': 'OTHER', 'fullName': 'Mahidol University'}, 'officialTitle': 'The Additive Anti-inflammatory Effect of Simvastatin in Combination With Inhaled Corticosteroids on p38 MAPK in Asthma', 'orgStudyIdInfo': {'id': 'si481/2010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'simvastatin', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'B1-6-12', 'interventionNames': ['Drug: Simvastatin', 'Drug: B1-6-12']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['Zocor'], 'description': '10 mg once daily for 8 weeks', 'armGroupLabels': ['B1-6-12', 'simvastatin']}, {'name': 'B1-6-12', 'type': 'DRUG', 'description': '1 tablet once daily for 8 weeks', 'armGroupLabels': ['B1-6-12']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'BKK', 'country': 'Thailand', 'facility': 'Division of Respiratory Disease and TB, Siriraj Hospital'}], 'overallOfficials': [{'name': 'Kittipong - Maneechotesuwan, MD., PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Siriraj Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mahidol University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Kittipong Maneechotesuwan', 'investigatorAffiliation': 'Mahidol University'}}}}