Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2025-12-29 @ 6:31 PM
Study NCT ID:
NCT00322868
Status:
COMPLETED
Last Update Posted:
2018-02-23
First Post:
2006-05-04
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003550', 'term': 'Cystic Fibrosis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077205', 'term': 'Pioglitazone'}], 'ancestors': [{'id': 'D045162', 'term': 'Thiazolidinediones'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael.konstan@case.edu', 'phone': '2168443267', 'title': 'Michael W Konstan, MD', 'organization': 'Case Western Reserve University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pioglitazone (30 mg)', 'description': 'After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally,30 mg, once daily for 28 days', 'otherNumAtRisk': 20, 'otherNumAffected': 1, 'seriousNumAtRisk': 20, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'hypoglycemic event', 'notes': 'Non serious, unexpected, possibly study related', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sputum White Cell Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Results pre-Pioglitazone dosing'}, {'id': 'OG001', 'title': 'Post-Treatment', 'description': 'Results following 28 days of Pioglitazone (oral, 30mg, once daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.93', 'spread': '0.40', 'groupId': 'OG000'}, {'value': '6.81', 'spread': '0.41', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2772', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Paired t-test analysis of the intra-subject change in log10 sputum white cell count'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 29', 'description': 'The total number of white cells log 10 cells/mL', 'unitOfMeasure': 'log 10 (cells/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples."}, {'type': 'PRIMARY', 'title': 'Sputum Neutrophil Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Results pre-Pioglitazone dosing'}, {'id': 'OG001', 'title': 'Post-Treatment', 'description': 'Results following 28 days of Pioglitazone (oral, 30mg, once daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '6.88', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '6.75', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2467', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Paired t-test analysis of the intra-subject change in log10 sputum neutrophil count'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 29', 'description': 'sputum neutrophils log 10 (cells/mL)', 'unitOfMeasure': 'log 10 (cells/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples."}, {'type': 'PRIMARY', 'title': 'Sputum Neutrophil Percent', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Results pre-Pioglitazone dosing'}, {'id': 'OG001', 'title': 'Post-Treatment', 'description': 'Results following 28 days of Pioglitazone (oral, 30mg, once daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '82.47', 'spread': '11.88', 'groupId': 'OG000'}, {'value': '74.44', 'spread': '17.07', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0288', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Paired t-test analysis of the intra-subject change in sputum percent neutrophils'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 29', 'description': 'Neutrophils as a percent of the total white cells.', 'unitOfMeasure': 'Percent (%) of white blood cells', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples."}, {'type': 'PRIMARY', 'title': 'Sputum Active Elastase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Results pre-Pioglitazone dosing'}, {'id': 'OG001', 'title': 'Post-Treatment', 'description': 'Results following 28 days of Pioglitazone (oral, 30mg, once daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '2.03', 'spread': '0.36', 'groupId': 'OG000'}, {'value': '1.96', 'spread': '0.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Paired t-test analysis of the intra-subject change in log10 sputum active elastase'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 29', 'description': 'Log 10 of Concentration of active Elastase in mcg/mL', 'unitOfMeasure': 'log 10 (mcg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples."}, {'type': 'PRIMARY', 'title': 'Sputum TNFα', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Results pre-Pioglitazone dosing'}, {'id': 'OG001', 'title': 'Post-Treatment', 'description': 'Results following 28 days of Pioglitazone (oral, 30mg, once daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.74', 'spread': '0.49', 'groupId': 'OG000'}, {'value': '1.69', 'spread': '0.59', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.62', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Paired t-test analysis of the intra-subject change in log10 sputum TNFα'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 29', 'description': 'The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)', 'unitOfMeasure': 'log 10 (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples."}, {'type': 'PRIMARY', 'title': 'Sputum IL-1ß', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Results pre-Pioglitazone dosing'}, {'id': 'OG001', 'title': 'Post-Treatment', 'description': 'Results following 28 days of Pioglitazone (oral, 30mg, once daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '4.05', 'spread': '0.42', 'groupId': 'OG000'}, {'value': '3.99', 'spread': '0.52', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.50', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Paired t-test analysis of the intra-subject change in log10 sputum IL-1ß'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 29', 'description': 'The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)', 'unitOfMeasure': 'log 10 (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples."}, {'type': 'PRIMARY', 'title': 'Sputum IL-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Results pre-Pioglitazone dosing'}, {'id': 'OG001', 'title': 'Post-Treatment', 'description': 'Results following 28 days of Pioglitazone (oral, 30mg, once daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '1.38', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '1.41', 'spread': '0.32', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Paired t-test analysis of the intra-subject change in log10 sputum IL-6'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 29', 'description': 'The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)', 'unitOfMeasure': 'log 10 (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples."}, {'type': 'PRIMARY', 'title': 'Sputum IL-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Baseline', 'description': 'Results pre-Pioglitazone dosing'}, {'id': 'OG001', 'title': 'Post-Treatment', 'description': 'Results following 28 days of Pioglitazone (oral, 30mg, once daily)'}], 'classes': [{'categories': [{'measurements': [{'value': '5.13', 'spread': '0.35', 'groupId': 'OG000'}, {'value': '5.10', 'spread': '0.34', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.75', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Paired t-test analysis of the intra-subject change in log10 sputum IL-8'}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 and Day 29', 'description': 'Concentration of Interleukin-8 log 10 (pg/mL)', 'unitOfMeasure': 'log 10 (pg/mL)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pioglitazone (30 mg)', 'description': 'After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally, 30 mg, once daily, for 28 days'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '21'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'disease progression', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'All patients who will be approached for participation in this trial will first be identified using either Port CF (CFF Registry) or CF Center database. Once potentials are identified a chart review will be conducted to determine eligibility. Patients will approached at clinic for possible participation in the study.', 'preAssignmentDetails': 'Washout: A 4 week washout from chronic use of NSAIDs, corticosteroids and oral meds to treat diabetes will be required. Subjects will be excluded if they take these medication within 72 hours of Visit 1. Subjects using alternate month tobramycin for inhalation (TOBI) will need to be on an off cycle to participate in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Pioglitazone (30 mg)', 'description': 'After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally, 30 mg, once daily, for 28 days'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '30', 'spread': '9.28', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'great or equal to 18 years of age', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 subject withdrawn due to disease progression'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '8', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 subject was withdrawn and no samples analyzed'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '20', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 subject withdrawn due to disease progression. no samples analyzed.'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 subject withdrawn due to disease progression no samples analyzed'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': '1 subject was withdrawn due to disease progression. No samples analyzed.'}, {'title': 'Total white cell count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.93', 'spread': '0.40', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'log 10 (cells/mL)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 subject withdrawn due to disease progression. No samples analyzed.'}, {'title': 'Total neutrophil count', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '6.88', 'spread': '0.39', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Log 10 (PMN/mL)', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 subject withdrawn due to disease progression. No samples analyzed.'}, {'title': 'percent neutrophils', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '82.47', 'spread': '11.88', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percent of white blood cells', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': '1 subject withdrawn due to disease progression. No samples analyzed'}], 'populationDescription': '21 subjects were screened and enrolled with 1 subject withdrawal due to disease progression.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'This was open-label and no one was masked.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-21', 'studyFirstSubmitDate': '2006-05-04', 'resultsFirstSubmitDate': '2016-12-03', 'studyFirstSubmitQcDate': '2006-05-04', 'lastUpdatePostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-02-21', 'studyFirstPostDateStruct': {'date': '2006-05-08', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2006-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sputum White Cell Count', 'timeFrame': 'Day 0 and Day 29', 'description': 'The total number of white cells log 10 cells/mL'}, {'measure': 'Sputum Neutrophil Count', 'timeFrame': 'Day 0 and Day 29', 'description': 'sputum neutrophils log 10 (cells/mL)'}, {'measure': 'Sputum Neutrophil Percent', 'timeFrame': 'Day 0 and Day 29', 'description': 'Neutrophils as a percent of the total white cells.'}, {'measure': 'Sputum Active Elastase', 'timeFrame': 'Day 0 and Day 29', 'description': 'Log 10 of Concentration of active Elastase in mcg/mL'}, {'measure': 'Sputum TNFα', 'timeFrame': 'Day 0 and Day 29', 'description': 'The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)'}, {'measure': 'Sputum IL-1ß', 'timeFrame': 'Day 0 and Day 29', 'description': 'The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)'}, {'measure': 'Sputum IL-6', 'timeFrame': 'Day 0 and Day 29', 'description': 'The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)'}, {'measure': 'Sputum IL-8', 'timeFrame': 'Day 0 and Day 29', 'description': 'Concentration of Interleukin-8 log 10 (pg/mL)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Prescription drugs', 'Administration, oral', 'Durable medical equipment', 'Kinetics'], 'conditions': ['Cystic Fibrosis']}, 'descriptionModule': {'briefSummary': 'Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease.\n\nPrimary outcomes: Markers of inflammation (neutrophils, elastase, cytokines and bacteria)will be measured in induced sputum specimens before and after a 4 week treatment period with pioglitazone in clinically stable CF patients.', 'detailedDescription': '* Single-center, open label study of pioglitazone in clinically stable patients with mild to moderate CF lung disease\n* Induced sputum will be obtained from each subject at enrollment (Baseline) and again following 28 days of pioglitazone treatment (End of Treatment)\n* Changes in markers of inflammation in the sputum samples will be assessed\n* Safety measures, including complete blood count (CBC), serum chemistry, Erythrocyte sedimentation rate (ESR), C-Reactive Protein (CRP), urinalysis and spirometry, will also be assessed'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female \\>= 28 years of age\n* Confirmed diagnosis of cystic fibrosis\n* Forced Expiratory Volume in 1 second (FEV1) \\>= 40% predicted\n* Clinically stable\n* Ability to reproduce spirometry\n* Ability to understand and sign the informed consent\n\nExclusion Criteria:\n\n* Use of an investigational agent within 4-week period prior to Visit 1\n* Chronic daily use of ibuprofen or other NSAIDS\n* Chronic daily use of insulin,oral diabetic agents or oral hypoglycemic agents\n* History of hypersensitivity to beta agonists\n* History of hypersensitivity to glitazones\n* Oxygen saturation\\<92%\n* Pregnant, breastfeeding or unwilling to practice acceptable birth control\n* History of hemoptysis \\>30cc per episode within 30 days prior to Visit 1\n* Significant history of hepatic, cardiovascular, renal,neurologic, hematologic or peptic ulcer disease\n* Serum Glutamic-Oxaloacetic Transaminase (SGOT)/(Serum Glutamic Pyruvic Transaminase (SGPT) \\>3 times the upper limit of normal at screening, documented biliary cirrhosis,or portal hypertension\n* Creatinine \\> 1.8 mg/dL at screening\n* Inability to swallow pills\n* Presence or abnormality that in the opinion of the investigator would compromise the safety or the quality of the data\n* Subjects who have routinely taken ibuprofen or other NSAIDS; prednisone or other systemic corticosteroids, or insulin, or oral diabetic agents within 4 weeks prior to visit 1 or who have taken these medications as needed within 72 hours prior to visit one will be excluded'}, 'identificationModule': {'nctId': 'NCT00322868', 'briefTitle': 'Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'University Hospitals Cleveland Medical Center'}, 'officialTitle': 'A Pilot Study Assessing the Safety and Efficacy of Pioglitazone as an Anti-inflammatory Agent for the Treatment of CF Lung Disease in Patients With Cystic Fibrosis', 'orgStudyIdInfo': {'id': 'CFFTI-Pio001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pioglitazone', 'description': 'All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda', 'interventionNames': ['Drug: pioglitazone']}], 'interventions': [{'name': 'pioglitazone', 'type': 'DRUG', 'otherNames': ['Actos', 'Takeda'], 'description': 'All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.', 'armGroupLabels': ['Pioglitazone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': "Rainbow Babies and Children's Hospital", 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}], 'overallOfficials': [{'name': 'Michael W. Konstan, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Case University and Rainbow Babies and Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individualized personal data (IPD) will not be shared'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospitals Cleveland Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cystic Fibrosis Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Pediatrics', 'investigatorFullName': 'Michael W. Konstan', 'investigatorAffiliation': 'University Hospitals Cleveland Medical Center'}}}}