Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-31 @ 1:53 AM
Study NCT ID:
NCT02070133
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
2013-10-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy of Simvastatin for the Treatment of COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}], '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'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial 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': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-21', 'studyFirstSubmitDate': '2013-10-14', 'studyFirstSubmitQcDate': '2014-02-21', 'lastUpdatePostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-02-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Endothelial Dysfunction (Arterial Stiffness)', 'timeFrame': 'Day 1 and day 84 (end of of week 12)'}], 'secondaryOutcomes': [{'measure': 'Systemic inflammation', 'timeFrame': 'Day 1 and day 84 (end of of week 12)'}, {'measure': 'BODE index', 'timeFrame': 'Day 1 and day 84 (end of of week 12)'}, {'measure': 'Uric acid', 'timeFrame': 'Day 1 and day 84 (end of of week 12)'}, {'measure': 'Vascular growth factors', 'timeFrame': 'Day 1 and day 84 (end of of week 12)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Chronic Bronchitis', 'Statins', 'Endothelial dysfunction', 'Systemic inflammation', 'BODE index', 'Uric acid', 'Vascular growth factors'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'To evaluate in patients with stable Chronic Obstructive Pulmonary Disease (COPD) the efficacy of statins (simvastatin) on: (1) endothelial function; (2) systemic inflammation; (3)BODE (B: body mass , O: bronchial obstruction, D: dyspnea and, E: exercise tolerance) index; (4) Uric acid; and, (5)vascular growth factors. Design: a 12 weeks randomized (1:1), double-blind, placebo control study. Population: 18 males with stable COPD between 40-80 years of age, exsmokers, with Forced expiratory volume in one second (FEV1) between 30 and 80% predicted post-bronchodilation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Stable COPD between 40-80 years of age, exsmokers, with FEV1 lower that 80% predicted post-bronchodilation.\n\nExclusion Criteria:\n\n* Severe co-morbidity (advanced-stage cancer, tuberculosis affecting more than a third of the total lung parenchyma, pneumonectomy, pneumoconiosis, left cardiac failure previously reported, known cardiopathy with ventricular dysfunction (ejection fraction \\< 45%) or any cardiovascular disease, Diabetes Mellitus treated with insulin, Hypercholesterolemia, Chronic inflammatory diseases (asthma, rheumatoid arthritis, lung fibrosis, autoimmune diseases), Treatment with systemic steroid, non steroidal anti-inflammatory drugs or stains within 3 months prior to inclusion.'}, 'identificationModule': {'nctId': 'NCT02070133', 'briefTitle': 'Efficacy of Simvastatin for the Treatment of COPD', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitari Son Dureta'}, 'officialTitle': 'Pilot Study on the Efficacy of Statins for the Treatment of Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'EC08/00123'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Simvastatin', 'description': 'Patients with COPD will receive simvastatin 40 mg once a day for 12 weeks', 'interventionNames': ['Drug: Simvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients with COPD will receive placebo once a day during 12 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Simvastatin', 'type': 'DRUG', 'description': 'Simvastatin 40 mg once a day during 12 weeks', 'armGroupLabels': ['Simvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo once a day during 12 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07110', 'city': 'Bunyola', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Fundacio Caubet-CIMERA', 'geoPoint': {'lat': 39.69634, 'lon': 2.69955}}, {'zip': '07010', 'city': 'Palma Mallorca', 'state': 'Balearic Islands', 'country': 'Spain', 'facility': 'Hospital Son Espases'}], 'overallOfficials': [{'name': 'Ernest Sala, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Son Espases, Palma Mallorca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitari Son Dureta', 'class': 'OTHER'}, 'collaborators': [{'name': "Fundació d'investigació Sanitària de les Illes Balears", 'class': 'OTHER_GOV'}, {'name': 'Cimera', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Doctor', 'investigatorFullName': 'Ernest Sala', 'investigatorAffiliation': 'Hospital Son Espases'}}}}