Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT00413205
Status:
COMPLETED
Last Update Posted:
2016-11-02
First Post:
2006-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004646', 'term': 'Emphysema'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000097768', 'term': 'Retinoic Acid Receptor gamma'}], 'ancestors': [{'id': 'D018168', 'term': 'Receptors, Retinoic Acid'}, {'id': 'D018160', 'term': 'Receptors, Cytoplasmic and Nuclear'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014157', 'term': 'Transcription Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 491}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2016-07-06', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-01', 'studyFirstSubmitDate': '2006-12-18', 'dispFirstSubmitQcDate': '2016-07-06', 'studyFirstSubmitQcDate': '2006-12-18', 'dispFirstPostDateStruct': {'date': '2016-07-11', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2016-11-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-12-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-bronchodilator FEVI', 'timeFrame': 'At intervals throughout study, and 2 and 6 months after cessation of study drug'}], 'secondaryOutcomes': [{'measure': 'DLCo, lung densitometry, SGRQ, lung volume, walk test, time to first COPD exacerbation.', 'timeFrame': 'At intervals throughout study'}, {'measure': 'AEs, SAEs, retinoid side effects, lab parameters.', 'timeFrame': 'Thoughout study'}]}, 'conditionsModule': {'conditions': ['Emphysema']}, 'descriptionModule': {'briefSummary': 'This 2 arm study will investigate the efficacy, safety and tolerability of RAR Gamma versus placebo in ex-smokers with moderate or severe emphysema treated with optimal COPD therapy. Following optimization of COPD therapy (up to 6 weeks) patients will be randomized to receive either RAR Gamma (5mg) or placebo once daily using a 2:1 ratio (active:placebo), in addition to their standard therapy. Following the double-blind treatment period, patients will enter a 4-week follow-up period. The anticipated time on study period is 1-2 years, and the target sample size is 100-500 individuals.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '44 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients of \\>44 years of age, with \\>10 pack-year smoking history;\n* women not of child-bearing potential;\n* ex-smokers (must have stopped smoking for \\>=12 months) with clinical diagnosis of emphysema;\n* willing to be switched to optimal COPD therapy.\n\nExclusion Criteria:\n\n* off oral steroids \\>28 days prior to enrollment;\n* \\>2 exacerbations of pulmonary symptoms requiring outpatient treatment, or \\>1 exacerbation requiring hospitalization, within 12 months prior to screening;\n* exposure to synthetic oral retinoids in past 12 months;\n* history of allergy or sensitivity to retinoids.'}, 'identificationModule': {'nctId': 'NCT00413205', 'briefTitle': 'TESRA: (Treatment of Emphysema With a Gamma-Selective Retinoid Agonist)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hoffmann-La Roche'}, 'officialTitle': 'A Double-blind, Placebo-controlled Efficacy (as Assessed by Post-bronchodilator FEV1) and Safety Study of RAR Gamma in Subjects With Smoking-related, Moderate to Severe COPD With Emphysema Receiving Concurrent Optimised COPD Drug Therapy.', 'orgStudyIdInfo': {'id': 'NB19751'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'po daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'RAR Gamma', 'description': '5mg po daily', 'interventionNames': ['Drug: RAR Gamma']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'description': 'po daily', 'armGroupLabels': ['Placebo']}, {'name': 'RAR Gamma', 'type': 'DRUG', 'description': '5mg po daily', 'armGroupLabels': ['RAR Gamma']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35299', 'city': 'Birmingham', 'state': 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