Ignite Creation Date:
2025-12-24 @ 10:07 PM
Ignite Modification Date:
2025-12-28 @ 10:28 AM
Study NCT ID:
NCT01134835
Status:
TERMINATED
Last Update Posted:
2015-12-03
First Post:
2010-05-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PPAR-gamma: a Novel Therapeutic Target for 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'whyStopped': 'safety concerns with pioglitazone', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-01', 'studyFirstSubmitDate': '2010-05-28', 'studyFirstSubmitQcDate': '2010-06-01', 'lastUpdatePostDateStruct': {'date': '2015-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'FEV1 after 12 weeks treatment', 'timeFrame': 'week 12'}], 'secondaryOutcomes': [{'measure': 'Change in symptoms', 'timeFrame': '12 weeks', 'description': 'Change over 12 weeks in daily asthma symptoms, mean morning and evening PEF, Juniper asthma control questionnaire and asthma quality of life questionnaire scores, exhaled nitric oxide level, bronchial hyper-responsiveness, induced sputum cell counts and analysis detailed above, adverse effects'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '27560168', 'type': 'DERIVED', 'citation': 'Anderson JR, Mortimer K, Pang L, Smith KM, Bailey H, Hodgson DB, Shaw DE, Knox AJ, Harrison TW. Evaluation of the PPAR-gamma Agonist Pioglitazone in Mild Asthma: A Double-Blind Randomized Controlled Trial. PLoS One. 2016 Aug 25;11(8):e0160257. doi: 10.1371/journal.pone.0160257. eCollection 2016.'}]}, 'descriptionModule': {'briefSummary': 'To test the hypothesis that stimulation of PPAR-γ receptors has a therapeutic role in the treatment of asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18-75 of either sex with a clinical diagnosis of asthma,\n* FEV1 ≥ 60% predicted and an increase in FEV1 of greater than 12% following inhaled salbutamol 400μg or Peak Expiratory Flow (PEF) variability \\>12% during run-in.\n* Allowed medication: 0-800μg inhaled beclomethasone diproprionate or equivalent and as required short acting beta agonist.\n\nExclusion Criteria:\n\n* Current smoking,\n* \\> 10 pack years smoking history,\n* Treatment with leukotriene antagonists,\n* Liver or cardiovascular disease,\n* Oral steroid treatment or exacerbation within 6 weeks,\n* Females who are pregnant, lactating or not using adequate contraception,\n* Any contra-indication to pioglitazone (hypersensitivity to pioglitazone, cardiac failure, history of cardiac failure, hepatic impairment, diabetic ketoacidosis),\n* Oral or insulin treatment for diabetes,\n* Treatment with gemfibrozil or rifampicin.'}, 'identificationModule': {'nctId': 'NCT01134835', 'briefTitle': 'PPAR-gamma: a Novel Therapeutic Target for Asthma?', 'organization': {'class': 'OTHER', 'fullName': 'University of Nottingham'}, 'officialTitle': 'PPAR-gamma: a Novel Therapeutic Target in Asthma?', 'orgStudyIdInfo': {'id': '08028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'IMP Pioglitazone', 'description': 'Pioglitazone 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks and placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks.', 'interventionNames': ['Drug: IMP Pioglitozone']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks and placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'placebo', 'type': 'OTHER', 'description': 'placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks', 'armGroupLabels': ['Placebo']}, {'name': 'IMP Pioglitozone', 'type': 'DRUG', 'description': 'Pioglitazone 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks and placebo 30mg daily by mouth for 4 weeks then 45mg daily for 8 weeks.', 'armGroupLabels': ['IMP Pioglitazone']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nottingham', 'country': 'United Kingdom', 'facility': 'Nottingham University Hospitals NHS Trust', 'geoPoint': {'lat': 52.9536, 'lon': -1.15047}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nottingham', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}