Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-26 @ 6:48 PM
Study NCT ID:
NCT00929734
Status:
COMPLETED
Last Update Posted:
2015-10-08
First Post:
2009-06-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D050197', 'term': 'Atherosclerosis'}], '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': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068718', 'term': 'Rosuvastatin Calcium'}, {'id': 'D019161', 'term': 'Hydroxymethylglutaryl-CoA Reductase Inhibitors'}], 'ancestors': [{'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D005464', 'term': 'Fluorobenzenes'}, {'id': 'D006845', 'term': 'Hydrocarbons, Fluorinated'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000924', 'term': 'Anticholesteremic Agents'}, {'id': 'D000960', 'term': 'Hypolipidemic Agents'}, {'id': 'D000963', 'term': 'Antimetabolites'}, {'id': 'D045504', 'term': 'Molecular Mechanisms of Pharmacological Action'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D004791', 'term': 'Enzyme Inhibitors'}, {'id': 'D057847', 'term': 'Lipid Regulating Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'torbjorn.omland@medisin.uio.no', 'phone': '+47 40107050', 'title': 'Professor Torbjørn Omland', 'organization': 'University of Oslo'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '3 months', 'description': 'Data are presented for all patients with adverse event registration (patient diary).\n\nThe 2 patients lost to follow-up in the rosuvastatin arm had missing adverse event data.\n\n2 of 3 patients without control investigation in the placebo arm withdrew, but provided adverse event data.', 'eventGroups': [{'id': 'EG000', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin: 10mg tablets, once daily in three months', 'otherNumAtRisk': 47, 'otherNumAffected': 12, 'seriousNumAtRisk': 47, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo: 1 tablet, once daily in three months', 'otherNumAtRisk': 49, 'otherNumAffected': 21, 'seriousNumAtRisk': 49, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'AECOPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 12, 'numAffected': 12}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Stomach pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myalgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Orthostatic vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Migraine', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ankle edema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cold', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial flutter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Acute exacerbation of chronic obstructive pulmonary disease (AECOPD)', 'notes': 'Hospitalization for AECOPD', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypophysis apoplexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relative Change in Reactive Hyperemia Index (RHI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin: 10mg tablets, once daily in three months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 1 tablet, once daily in three months'}], 'classes': [{'categories': [{'measurements': [{'value': '6.65', 'groupId': 'OG000', 'lowerLimit': '1.80', 'upperLimit': '15.11'}, {'value': '-1.27', 'groupId': 'OG001', 'lowerLimit': '-8.33', 'upperLimit': '5.79'}]}]}], 'analyses': [{'pValue': '0.292', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'description': 'Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment.', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis'}, {'type': 'SECONDARY', 'title': 'Relative Change in FEV1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin: 10mg tablets, once daily in three months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 1 tablet, once daily in three months'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'groupId': 'OG000', 'lowerLimit': '-2.2', 'upperLimit': '7.5'}, {'value': '-1.1', 'groupId': 'OG001', 'lowerLimit': '-4.7', 'upperLimit': '2.5'}]}]}], 'analyses': [{'pValue': '0.462', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 3 months', 'unitOfMeasure': 'percent change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis'}, {'type': 'SECONDARY', 'title': 'Relative Change in High-sensitivity C-reactive Protein', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin: 10mg tablets, once daily in three months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 1 tablet, once daily in three months'}], 'classes': [{'categories': [{'measurements': [{'value': '-20.0', 'groupId': 'OG000', 'lowerLimit': '-45.8', 'upperLimit': '14.3'}, {'value': '11.0', 'groupId': 'OG001', 'lowerLimit': '-35.1', 'upperLimit': '93.3'}]}]}], 'analyses': [{'pValue': '0.017', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'ANCOVA with natural logarithm of hs-CRP (ln hs-CRP)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 3 months', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis'}, {'type': 'SECONDARY', 'title': 'Relative Change in Interleukin 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin: 10mg tablets, once daily in three months'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo: 1 tablet, once daily in three months'}], 'classes': [{'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000', 'lowerLimit': '-20', 'upperLimit': '43.8'}, {'value': '30', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '52.2'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'ANCOVA with natural logarithm of interleukin 6 (ln IL6)', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Baseline to 3 months', 'unitOfMeasure': 'percent change', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Complete case analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin: 10mg tablets, once daily in three months'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo: 1 tablet, once daily in three months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '49'}, {'groupId': 'FG001', 'numSubjects': '50'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '47'}, {'groupId': 'FG001', 'numSubjects': '47'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Rosuvastatin', 'description': 'Rosuvastatin 10mg tablet'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo tablet'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '63', 'spread': '6.6', 'groupId': 'BG001'}, {'value': '65', 'spread': '6.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '45', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '3.8', 'groupId': 'BG000'}, {'value': '24', 'spread': '4.1', 'groupId': 'BG001'}, {'value': '24', 'spread': '3.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Systolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '131', 'spread': '17.7', 'groupId': 'BG000'}, {'value': '135', 'spread': '20.1', 'groupId': 'BG001'}, {'value': '133', 'spread': '18.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Diastolic blood pressure', 'classes': [{'categories': [{'measurements': [{'value': '79', 'spread': '8.4', 'groupId': 'BG000'}, {'value': '80', 'spread': '10.3', 'groupId': 'BG001'}, {'value': '80', 'spread': '9.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Heart rate', 'classes': [{'categories': [{'measurements': [{'value': '68', 'spread': '11.2', 'groupId': 'BG000'}, {'value': '67', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '67', 'spread': '11.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'beats/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'History of hypertension', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '71', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of asthma', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Pack-years', 'classes': [{'categories': [{'measurements': [{'value': '39', 'spread': '16.1', 'groupId': 'BG000'}, {'value': '35', 'spread': '15.5', 'groupId': 'BG001'}, {'value': '37', 'spread': '15.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Number of packs of cigarettes smoked per day by the number of years the person has smoked', 'unitOfMeasure': 'pack-years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Current smoking', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Haemoglobin', 'classes': [{'categories': [{'measurements': [{'value': '14.1', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '14.0', 'spread': '0.2', 'groupId': 'BG001'}, {'value': '14.0', 'spread': '1.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'g/dl', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Estimated Glomerular Filtration Rate (eGFR)', 'classes': [{'categories': [{'measurements': [{'value': '82.4', 'spread': '19.6', 'groupId': 'BG000'}, {'value': '90.1', 'spread': '29.4', 'groupId': 'BG001'}, {'value': '86.2', 'spread': '25.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Renal function as calculated by the Cockcroft-Gault formula ((140- age) × bodyweight/serum creatinine) (× 0.85 for women))', 'unitOfMeasure': 'ml/min', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Leucocyte count', 'classes': [{'categories': [{'measurements': [{'value': '6.6', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '6.9', 'spread': '1.7', 'groupId': 'BG001'}, {'value': '6.7', 'spread': '1.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cells*10^9/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'High-sensitivity C-reactive protein', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'groupId': 'BG000', 'lowerLimit': '0.8', 'upperLimit': '3.7'}, {'value': '1.8', 'groupId': 'BG001', 'lowerLimit': '1.0', 'upperLimit': '4.4'}, {'value': '1.7', 'groupId': 'BG002', 'lowerLimit': '0.8', 'upperLimit': '3.8'}]}]}], 'paramType': 'MEDIAN', 'description': 'Acute-phase reactant used in cardiovascular risk assessment', 'unitOfMeasure': 'mg/L', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Interleukin 6', 'classes': [{'categories': [{'measurements': [{'value': '4.1', 'groupId': 'BG000', 'lowerLimit': '2.9', 'upperLimit': '5.3'}, {'value': '3.4', 'groupId': 'BG001', 'lowerLimit': '2.7', 'upperLimit': '4.7'}, {'value': '3.7', 'groupId': 'BG002', 'lowerLimit': '2.7', 'upperLimit': '5.1'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Glucose', 'classes': [{'categories': [{'measurements': [{'value': '5.0', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '5.1', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '5.0', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Cholesterol', 'classes': [{'categories': [{'measurements': [{'value': '5.5', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '5.7', 'spread': '1.1', 'groupId': 'BG001'}, {'value': '5.6', 'spread': '1.0', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'LDL-C', 'classes': [{'categories': [{'measurements': [{'value': '3.3', 'spread': '0.8', 'groupId': 'BG000'}, {'value': '3.5', 'spread': '0.9', 'groupId': 'BG001'}, {'value': '3.4', 'spread': '0.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HDL-C', 'classes': [{'categories': [{'measurements': [{'value': '1.8', 'spread': '0.1', 'groupId': 'BG000'}, {'value': '1.8', 'spread': '0.1', 'groupId': 'BG001'}, {'value': '1.8', 'spread': '0.5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Triglycerides', 'classes': [{'categories': [{'measurements': [{'value': '1.0', 'spread': '0.4', 'groupId': 'BG000'}, {'value': '1.1', 'spread': '0.5', 'groupId': 'BG001'}, {'value': '1.1', 'spread': '0.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Forced expiratory volume at one second (FEV1)', 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '0.6', 'groupId': 'BG000'}, {'value': '1.5', 'spread': '0.7', 'groupId': 'BG001'}, {'value': '1.4', 'spread': '0.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Liter', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1, % of predicted', 'classes': [{'categories': [{'measurements': [{'value': '48.3', 'spread': '18.9', 'groupId': 'BG000'}, {'value': '52.1', 'spread': '18.8', 'groupId': 'BG001'}, {'value': '50.2', 'spread': '18.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Percent predicted value', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'FEV1/FVC', 'classes': [{'categories': [{'measurements': [{'value': '47', 'spread': '13.8', 'groupId': 'BG000'}, {'value': '49', 'spread': '11.8', 'groupId': 'BG001'}, {'value': '48', 'spread': '12.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Forced vital capacity (FVC)', 'unitOfMeasure': 'Percent of FVC', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Antihypertensive treatment', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '37', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Inhaled corticosteroids', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'including long acting beta agonists (LABA)', 'unitOfMeasure': 'participants'}, {'title': 'Long acting beta agonists', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Long acting muscarinic antagonists', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Anti-inflammatory treatment', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Oestrogen treatment', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '87', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Complete case population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-07', 'studyFirstSubmitDate': '2009-06-26', 'resultsFirstSubmitDate': '2015-07-09', 'studyFirstSubmitQcDate': '2009-06-26', 'lastUpdatePostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-09-07', 'studyFirstPostDateStruct': {'date': '2009-06-29', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-10-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relative Change in Reactive Hyperemia Index (RHI)', 'timeFrame': 'Baseline to 3 months', 'description': 'Endothelial function assessed with peripheral arterial tonometry, expressed as the reactive hyperemia index (RHI) as a marker for subclinical atherosclerosis and future cardiovascular risk assessment.'}], 'secondaryOutcomes': [{'measure': 'Relative Change in FEV1', 'timeFrame': 'Baseline to 3 months'}, {'measure': 'Relative Change in High-sensitivity C-reactive Protein', 'timeFrame': 'Baseline to 3 months'}, {'measure': 'Relative Change in Interleukin 6', 'timeFrame': 'Baseline to 3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Inflammation', 'Atherosclerosis', 'Hydroxymethylglutaryl-coenzyme A Reductase Inhibitors'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate whether rosuvastatin improves measures of endothelial function, decreases measures of inflammation, and improves pulmonary function in patients with stable chronic obstructive pulmonary disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Stable COPD patients of both genders with no COPD exacerbations less than three weeks prior to inclusion\n* COPD stage I to IV after the GOLD criteria (Global Initiative for Chronic Obstructive Lung Disease)\n* Age between 40 and 80 years\n\nExclusion criteria:\n\n* Diagnosed lung disease other than COPD, except chronic asthmatic bronchitis and mild bronchiectasis without or few physical signs (diagnosed by high resolution CT)\n* History of or active coronary artery disease (CAD), cerebrovascular or peripheral vascular disease\n* History of or clinically significant congestive heart failure, valvular heart disease, clinically significant arrhythmias or conduction delays\n* History of uncontrolled arterial hypertension (defined as blood pressure above180/110 mmHg with or without the use of antihypertensive medication)\n* Body mass index \\>40kg/m2\n* History of diabetes mellitus, measured fasting glucose \\> 11 mmol/L\n* History of Hypercholesterolemia, measured total cholesterol \\> 8 mmol/L\n* Known poliomyelitis, motor neurone disease, cranial or temporal arteritis, stroke or myopathy\n* Neutropenia, anemia (Hb \\< 8 g/100mL)\n* History of chronic renal failure, serum creatinine \\> 176 micromol/L (2.0mg/dL)\n* Creatine kinase \\> 3 times the upper limit of normal (ULN)\n* Acute or chronic liver disease (serum transaminases \\> 3 times the ULN)\n* Pregnancy (oral examination and blood test prior to inclusion)\n* Active abuse of drugs or alcohol, poor compliance anticipated\n* Statin use within the last 4 weeks prior to study start or previously clear indication for statin use\n* Prior diagnosis of statin induced myopathy or hypersensitivity reaction to another hydroxymethylglutaryl-Coenzyme A-reductase inhibitor incl. Rosuvastatin\n* History of malignant disease of any kind within 5 years prior to inclusion.\n* History of uncontrolled hypothyroidism\n* Participation in another pharmaceutical or medical device clinical trial study less than 4 weeks prior inclusion.\n* Use concomitant of medications that are known to interact with Crestor. This includes the following medications: Warfarin and other coumarin (vitamin K antagonist) anticoagulants, Cyclosporin, Gemfibrozil and Antacid'}, 'identificationModule': {'nctId': 'NCT00929734', 'acronym': 'RODEO', 'briefTitle': 'Effect of Rosuvastatin Therapy in Patients With Stable Chronic Obstructive Pulmonary Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Akershus'}, 'officialTitle': 'Effect of ROsuvastatin Therapy on Peripheral Vasodilator Function, Inflammatory Markers and Pulmonary Function in Patients With StablE Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': '2009A2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Rosuvastatin', 'interventionNames': ['Drug: Rosuvastatin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Rosuvastatin', 'type': 'DRUG', 'otherNames': ['Hydroxymethylglutaryl-CoA Reductase Inhibitor'], 'description': '10mg tablets, once daily in three months', 'armGroupLabels': ['Rosuvastatin']}, {'name': 'Placebo', 'type': 'DRUG', 'description': '1 tablet, once daily in three months', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1478', 'city': 'Lørenskog', 'state': 'Akershus', 'country': 'Norway', 'facility': 'Akershus University Hospital'}], 'overallOfficials': [{'name': 'Torbjørn Omland, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Akershus'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Akershus', 'class': 'OTHER'}, 'collaborators': [{'name': 'AstraZeneca', 'class': 'INDUSTRY'}, {'name': 'Haukeland University Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Torbjorn Omland', 'investigatorAffiliation': 'University Hospital, Akershus'}}}}