Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-01-10 @ 3:00 PM
Study NCT ID:
NCT02433535
Status:
WITHDRAWN
Last Update Posted:
2017-09-26
First Post:
2015-04-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trial of Simvastatin for the Treatment of Severe 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-22', 'studyFirstSubmitDate': '2015-04-29', 'studyFirstSubmitQcDate': '2015-05-04', 'lastUpdatePostDateStruct': {'date': '2017-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Th2 gene expression in nasal epithelial cells.', 'timeFrame': 'Before and after 12 weeks of drug or placebo intervention.', 'description': 'IL13, eotaxin-1,-2,-3, STAT6) by RT-PCR.'}, {'measure': 'Exhaled nitric oxide (ENO)', 'timeFrame': 'Before and after 12 weeks of drug or placebo intervention.', 'description': 'ENO will be measured using our NIOX-Mino portable NO analyzer.'}], 'secondaryOutcomes': [{'measure': 'Acute Exacerbations', 'timeFrame': 'Before and after 12 weeks of drug or placebo intervention.', 'description': 'Assessed as a rate per month.'}, {'measure': 'Lung function', 'timeFrame': 'Before and after 12 weeks of drug or placebo intervention.', 'description': 'FEV1, FVC, and FEV/FVC ratio.'}, {'measure': 'Asthma symptom control score', 'timeFrame': 'Before and after 12 weeks of drug or placebo intervention.', 'description': 'Asthma Control Test score (5 question survey).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['severe asthma', 'simvastatin', 'allergic airway inflammation'], 'conditions': ['Severe Asthma']}, 'descriptionModule': {'briefSummary': 'This purpose of this clinical trial is to determine if a statin drug, Simvastatin, added to inhaled corticosteroids and bronchodilators can reduce systemic and airway inflammation, improve lung function and symptoms, and reduce acute exacerbations in patients with severe asthma who are already on controller inhaler therapy.\n\nThis proposed investigator-initiated, single-center, early Phase II, cross-over, randomized clinical trial, titled "Randomized Trial of Simvastatin for the Treatment of Severe Asthma", will be conducted at the University of California, Davis Medical Center (UCDMC) in Sacramento, CA. This trial will evaluate Simvastatin for treatment of asthma in subjects with severe asthma (as defined by the American Thoracic Society (ATS)), who are already taking inhaler controller therapy. The investigators plan to enroll 24 patients with severe allergic asthma.\n\nThe investigators hypothesize that treatment with Simvastatin 40 mg (administered once daily) will not only improve indicators of airway and systemic allergic/Th2 inflammation, but will also reduce acute exacerbations and improve lung function. All patients will be on standard controller therapy including appropriate doses of inhaled corticosteroids and long-acting bronchodilators.', 'detailedDescription': 'See above.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. statin-naïve adults \\>18 years old with the ATS definition of severe asthma,\n2. on ICS and LABA,\n3. confirmation of allergic asthma (serum IgE \\>100 kU/L, positive radioallergosorbent test (RAST) panel, and/or peripheral blood absolute eosinophil count of ≥700/mm3),\n4. clinically stable for 4 weeks.\n\nExclusion Criteria:\n\n1. baseline FEV1 \\<30% predicted,\n2. current smokers or ex-smokers with \\>5 pack-years of smoking history,\n3. pregnant women, nursing/lactating mothers, or women of childbearing potential who are actively attempting to become pregnant,\n4. nasal or sinus surgery or trauma within 3 months of study participation,\n5. ischemic heart disease,\n6. liver disease, and\n7. the concurrent use of the following medications (amiodarone, verapamil, diltiazem, gemfibrozil, cyclosporine, antifungal azoles (itraconazole, ketoconazole, or voriconazole), and danazol.'}, 'identificationModule': {'nctId': 'NCT02433535', 'briefTitle': 'Trial of Simvastatin for the Treatment of Severe Asthma', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Randomized Trial of Simvastatin for the Treatment of Severe Asthma', 'orgStudyIdInfo': {'id': '522110'}, 'secondaryIdInfos': [{'id': '522110-3', 'type': 'OTHER', 'domain': 'UC Davis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simvastatin', 'description': 'Simvastatin 40 mg daily will be given for 12 weeks.', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'A placebo capsule will be given daily for 12 weeks.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'otherNames': ['Zocor'], 'description': 'Simvastatin is used to lower cholesterol, however, it also possess anti-inflammatory and immunomodulatory properties that may also alleviate allergic airway inflammation in asthma.', 'armGroupLabels': ['Simvastatin']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'A placebo pill will be given to the placebo group. There will be no detectible differences between study drug pill and placebo pill.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'CTSC Clinical Research Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}