Ignite Creation Date:
2025-12-24 @ 3:44 PM
Ignite Modification Date:
2026-01-04 @ 2:53 AM
Study NCT ID:
NCT02260492
Status:
COMPLETED
Last Update Posted:
2017-06-15
First Post:
2014-10-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068299', 'term': 'Salmeterol Xinafoate'}, {'id': 'D000068297', 'term': 'Fluticasone-Salmeterol Drug Combination'}], 'ancestors': [{'id': 'D000420', 'term': 'Albuterol'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D000068298', 'term': 'Fluticasone'}, {'id': 'D000730', 'term': 'Androstadienes'}, {'id': 'D000736', 'term': 'Androstenes'}, {'id': 'D000731', 'term': 'Androstanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'mlongphre@orieltherapeutics.com', 'phone': '9193131290', 'title': 'Malinda Longphre PhD, Director Clinical Reserach', 'phoneExt': '114', 'organization': 'Oriel Therapeutics, a Novartis Company'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'One patient was randomized to OT329 SOLIS treatment but was given a Placebo kit in error. They are included in the SOLIS group for the efficacy analysis and in the Placebo group for the safety analysis as dictated by the Statistical Analysis Plan.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from time of consent until 1 week post last treatment, up to 5 weeks. Adverse events from screen failed subjects are omitted.', 'description': 'Treatment emergent adverse events are reported from Day 1 of treatment.', 'eventGroups': [{'id': 'EG000', 'title': 'OT329 Solis', 'description': 'OT329 Solis (twice daily inhalation throughout the study)\n\nOT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler', 'otherNumAtRisk': 417, 'deathsNumAtRisk': 417, 'otherNumAffected': 52, 'seriousNumAtRisk': 417, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Advair Diskus', 'description': 'Advair Diskus (twice daily inhalation throughout the study)\n\nAdvair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler', 'otherNumAtRisk': 419, 'deathsNumAtRisk': 419, 'otherNumAffected': 47, 'seriousNumAtRisk': 419, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG002', 'title': 'Placebo', 'description': 'Placebo (twice daily inhalation throughout the study)\n\nPlacebo: Placebo (lactose) administered via the Solis dry powder inhaler', 'otherNumAtRisk': 43, 'deathsNumAtRisk': 43, 'otherNumAffected': 7, 'seriousNumAtRisk': 43, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 13, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Dysphonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'seriousEvents': [{'term': 'Myocardial Infarction', 'notes': 'Fatal heart attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}, {'term': 'H. pylori infection', 'notes': 'H. pylori gastrointestinal infection leading to hospitalization', 'stats': [{'groupId': 'EG000', 'numAtRisk': 417, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 419, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 16.1'}], 'frequencyThreshold': '1'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Serial FEV1-time Curve (AUC 0-12h)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'OG000'}, {'value': '419', 'groupId': 'OG001'}, {'value': '42', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OT329 Solis', 'description': 'OT329 Solis (twice daily inhalation throughout the study)\n\nOT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler'}, {'id': 'OG001', 'title': 'Advair Diskus', 'description': 'Advair Diskus (twice daily inhalation throughout the study)\n\nAdvair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (twice daily inhalation throughout the study)\n\nPlacebo: Placebo (lactose) administered via the Solis dry powder inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '29.610', 'spread': '9.044', 'groupId': 'OG000'}, {'value': '30.151', 'spread': '9.107', 'groupId': 'OG001'}, {'value': '27.270', 'spread': '7.710', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Test/Reference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0799', 'ciLowerLimit': '.8', 'ciUpperLimit': '1.25', 'groupDescription': 'Primary analyses were conducted on BL subtracted values (pre-dose - post-dose). The two one-sided tests method of interval analysis is standard for bioequivalence testing and employs 2 sets of one-sided hypotheses as follows, performed at the 5% alpha level:\n\nH01: uT-uR \\< -0.20 uR vs. Ha1: -0.20 uR \\</= uT- uR (the lower tail) and H02: uT-uR \\>0.25 uR vs. Ha2: uT- uR \\</=0.25 uR (the upper tail) When uT is the LSM SOLIS, uR is the LSM of ADVAIR DISKUS', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Equivalence test compares the Test/Reference with confidence bounds set at standard 80-125%.\n\nSuperiority test compares Test with Placebo (p\\<0.05) Superiority test compares Reference with Placebo (p\\<0.05) (p\\<0.05)', 'otherAnalysisDescription': 'Day 1 superiority to placebo:\n\nSolis vs. Placebo p=0.004 Advair vs. Placebo p=0.012'}], 'paramType': 'MEAN', 'timeFrame': '0-12 hours after dosing on Day 1', 'description': 'Bioequivalence comparison of lung function (FEV1) for 12 hours after the first dose on Day 1 following OT329 Solis and Advair Diskus treatment. Serial lung function measurements were made pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-treat (ITT)'}, {'type': 'PRIMARY', 'title': 'FEV1 Trough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '395', 'groupId': 'OG000'}, {'value': '406', 'groupId': 'OG001'}, {'value': '37', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OT329 Solis', 'description': 'OT329 Solis (twice daily inhalation throughout the study)\n\nOT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler'}, {'id': 'OG001', 'title': 'Advair Diskus', 'description': 'Advair Diskus (twice daily inhalation throughout the study)\n\nAdvair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (twice daily inhalation throughout the study)\n\nPlacebo: Placebo (lactose) administered via the Solis dry powder inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '2.516', 'spread': '0.792', 'groupId': 'OG000'}, {'value': '2.579', 'spread': '0.774', 'groupId': 'OG001'}, {'value': '2.323', 'spread': '0.736', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Test/Reference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.0475', 'ciLowerLimit': '.8', 'ciUpperLimit': '1.25', 'groupDescription': 'Same as the Day 1 analyses', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Standard bioequivalence 90% confidence bounds set at 0.8-1.25.', 'otherAnalysisDescription': 'Week 4 superiority to placebo:\n\nSolis vs. Placebo p=0.019 Advair vs. Placebo p=0.035'}], 'paramType': 'MEAN', 'timeFrame': 'Post-4 weeks of treatment', 'description': 'Bioequivalence comparison of trough lung function (FEV1) after 4 weeks of treatment with OT329 SOLIS or ADVAIR DISKUS.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '417', 'groupId': 'OG000'}, {'value': '418', 'groupId': 'OG001'}, {'value': '43', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'OT329 Solis', 'description': 'OT329 Solis (twice daily inhalation throughout the study)\n\nOT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler'}, {'id': 'OG001', 'title': 'Advair Diskus', 'description': 'Advair Diskus (twice daily inhalation throughout the study)\n\nAdvair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler'}, {'id': 'OG002', 'title': 'Placebo', 'description': 'Placebo (twice daily inhalation throughout the study)\n\nPlacebo: Placebo (lactose) administered via the Solis dry powder inhaler'}], 'classes': [{'categories': [{'measurements': [{'value': '67', 'groupId': 'OG000'}, {'value': '66', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From Screen (Day -28) until 1 week post last treatment', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One subject who was assigned OT329 SOLIS received placebo treatment kit in error. The mistake was discovered on Day 1 and the patient was removed from the study. The patient was included in the OT329 SOLIS group for the intent-to-treat analysis but was put in the Placebo group for the Safety analysis as defined by the Statisical Analysis Plan.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OT329 Solis', 'description': 'OT329 Solis (twice daily inhalation throughout the study)\n\nOT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler'}, {'id': 'FG001', 'title': 'Advair Diskus', 'description': 'Advair Diskus (twice daily inhalation throughout the study)\n\nAdvair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler'}, {'id': 'FG002', 'title': 'Placebo', 'description': 'Placebo (twice daily inhalation throughout the study)\n\nPlacebo: Placebo (lactose) administered via the Solis dry powder inhaler'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '418'}, {'groupId': 'FG001', 'numSubjects': '419'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'Completed Day 1', 'achievements': [{'groupId': 'FG000', 'numSubjects': '418'}, {'groupId': 'FG001', 'numSubjects': '419'}, {'groupId': 'FG002', 'numSubjects': '42'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '395'}, {'groupId': 'FG001', 'numSubjects': '406'}, {'groupId': 'FG002', 'numSubjects': '37'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': '1526 Patients with asthma were screened at 48 clinical sites', 'preAssignmentDetails': '647 Failed screening (42%)\n\n* 239 failed because they did not have 40-85% pred FEV1\n* 240 failed because they were not \\>15% reversible with albuterol\n* 168 failed for other inclusion/exclusion criteria'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '418', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '879', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'OT329 Solis', 'description': 'OT329 Solis (twice daily inhalation throughout the study)\n\nOT329 (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler'}, {'id': 'BG001', 'title': 'Advair Diskus', 'description': 'Advair Diskus (twice daily inhalation throughout the study)\n\nAdvair Diskus (combination of fluticasone propionate and salmeterol xinafoate): Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler'}, {'id': 'BG002', 'title': 'Placebo', 'description': 'Placebo (twice daily inhalation throughout the study)\n\nPlacebo: Placebo (lactose) administered via the Solis dry powder inhaler'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.9', 'spread': '14.52', 'groupId': 'BG000'}, {'value': '43.3', 'spread': '14.26', 'groupId': 'BG001'}, {'value': '43.2', 'spread': '15.25', 'groupId': 'BG002'}, {'value': '43.6', 'spread': '14.42', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '274', 'groupId': 'BG000'}, {'value': '251', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '555', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '324', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '122', 'groupId': 'BG000'}, {'value': '118', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '249', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '296', 'groupId': 'BG000'}, {'value': '301', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}, {'value': '630', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '173', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '332', 'groupId': 'BG000'}, {'value': '308', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}, {'value': '669', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '418', 'groupId': 'BG000'}, {'value': '419', 'groupId': 'BG001'}, {'value': '42', 'groupId': 'BG002'}, {'value': '879', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight (kg)', 'classes': [{'categories': [{'measurements': [{'value': '88.5', 'spread': '22.9', 'groupId': 'BG000'}, {'value': '85.9', 'spread': '23.1', 'groupId': 'BG001'}, {'value': '81.0', 'spread': '17.2', 'groupId': 'BG002'}, {'value': '86.9', 'spread': '22.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height (cm)', 'classes': [{'categories': [{'measurements': [{'value': '167.5', 'spread': '9.9', 'groupId': 'BG000'}, {'value': '169.2', 'spread': '10.7', 'groupId': 'BG001'}, {'value': '166.3', 'spread': '8.3', 'groupId': 'BG002'}, {'value': '168.2', 'spread': '10.2', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '31.49', 'spread': '7.61', 'groupId': 'BG000'}, {'value': '29.91', 'spread': '7.20', 'groupId': 'BG001'}, {'value': '29.32', 'spread': '6.30', 'groupId': 'BG002'}, {'value': '30.63', 'spread': '7.40', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Airways Reversibility with Albuterol', 'classes': [{'categories': [{'measurements': [{'value': '30.5', 'spread': '19.3', 'groupId': 'BG000'}, {'value': '29.7', 'spread': '17.5', 'groupId': 'BG001'}, {'value': '25.9', 'spread': '13.3', 'groupId': 'BG002'}, {'value': '29.9', 'spread': '18.3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Patients were screened for their airways reversibility following albuterol. Baseline FEV1 was measured then the patient received 360 mcg of albuterol (pMDI), a short-acting adrenergic agonist. Within 30 min of albuterol administration, lung function was measured again. Inclusion Criteria #5 required at least 15% reversibility or improvement in FEV1.', 'unitOfMeasure': '% change from pre-albuterol lung functio', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Intent-to-Treat (ITT)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 879}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-28', 'studyFirstSubmitDate': '2014-10-06', 'resultsFirstSubmitDate': '2017-02-10', 'studyFirstSubmitQcDate': '2014-10-08', 'lastUpdatePostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-03-28', 'studyFirstPostDateStruct': {'date': '2014-10-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Serial FEV1-time Curve (AUC 0-12h)', 'timeFrame': '0-12 hours after dosing on Day 1', 'description': 'Bioequivalence comparison of lung function (FEV1) for 12 hours after the first dose on Day 1 following OT329 Solis and Advair Diskus treatment. Serial lung function measurements were made pre-dose and 0.5, 1, 2, 3, 4, 6, 8, 10, and 12 hours postdose.'}, {'measure': 'FEV1 Trough', 'timeFrame': 'Post-4 weeks of treatment', 'description': 'Bioequivalence comparison of trough lung function (FEV1) after 4 weeks of treatment with OT329 SOLIS or ADVAIR DISKUS.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': 'From Screen (Day -28) until 1 week post last treatment'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '27849125', 'type': 'DERIVED', 'citation': 'Longphre MV, Getz EB, Fuller R. Clinical Bioequivalence of OT329 SOLIS and ADVAIR DISKUS in Adults with Asthma. Ann Am Thorac Soc. 2017 Feb;14(2):182-189. doi: 10.1513/AnnalsATS.201606-436OC.'}]}, 'descriptionModule': {'briefSummary': 'This is a study to establish the equivalence of OT329 Solis and Advair Diskus when administered by inhalation in patients with asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Males and females ≥ 18 years old of non-child bearing potential or of child bearing potential committing to consistent and correct use of an acceptable method of birth control\n2. Subjects with a reliable clinical history of asthma documented at least 12 weeks prior to screening\n3. Subjects with a pre-bronchodilator FEV1 of \\> 40% and \\<85% of the predicted value during the screening visit and on the first day of treatment\n4. Subjects who are currently non-smoking and have not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and had \\< 10 pack-years of historical use\n5. Subjects with \\> 15% reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI). Note: This test may be repeated on a different day if the patient fails the first attempt; and if the patient achieves at least 10% reversibility and the Investigator thinks that a second attempt is appropriate\n6. Subjects who are able to discontinue their asthma medications (inhaled corticosteroids and long-acting beta agonists) during the run-in period and for the remainder of the study\n7. Subjects who are able to replace current short-acting beta agonists (SABAs) with salbutamol/albuterol inhaler for use as needed for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits)\n8. Subjects who are able to continue the following medications without a significant adjustment of dosage, formulation, or dosing interval for the duration of the study, and judged able by the investigator to withhold them for the specified minimum time intervals prior to each clinic visit: short-acting forms of theophylline for 12 hours, twice-a-day controlled release forms of theophylline for 24 hours, once-a-day controlled-release forms of theophylline for 36 hours\n9. Subjects who are able to discontinue the following medications for the specified minimum time intervals prior to the run-in period and for the remainder of the study: oral and parenteral corticosteroids for 1 month and oral short-acting beta agonists for 12 hours\n10. Subjects who are able and willing to give their written informed consent to participate in the study.\n\n \\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\\*\n\n Exclusion Criteria:\n11. Female Subjects who are pregnant or breastfeeding\n12. Subjects who have life-threatening asthma in the last 10 years, as defined as a history of asthma episode(s) requiring intubation, and/or associated with hypercapnoea; respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within the past year or during the run-in period\n13. Subjects with evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study\n14. Subjects with a hypersensitivity to any sympathomimetic drug (e.g. Salmeterol or salbutamol/albuterol) or any inhaled, intranasal or systemic corticosteroid therapy\n15. Subjects who are on other medications with the potential to affect the course of asthma or to interact with sympathomimetic amines (e.g. beta blockers, oral decongestants, benzodiazepines, digitalis, phenothiazines, polycyclic antidepressants, monoamine oxidase inhibitors)\n16. Subjects with a viral or bacterial upper or lower respiratory tract infection or sinus or middle ear infection within 4 weeks prior to the screening visit or during the run-in period\n17. Subjects with any factors (e.g. infirmity, disability, or geographic location) that the investigator feel would likely limit the patient's compliance with the study protocol or scheduled clinic visits\n18. Subjects who have used any investigational drug in any clinical trial within 1 month of receiving the first dose of OT329 Solis™ study medication\n19. Subjects who cannot communicate reliably or who are unlikely to co-operate with the requirements of the study, in the opinion of the Investigator\n20. Subjects with a milk protein allergy"}, 'identificationModule': {'nctId': 'NCT02260492', 'briefTitle': 'Clinical Efficacy Study of Salmeterol Xinafoate/Fluticasone Propionate in Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oriel Therapeutics'}, 'officialTitle': 'Clinical Endpoint Study of Salmeterol Xinafoate/Fluticasone Propionate Combination for Comparison of a Test and Reference Product in Patients With Asthma', 'orgStudyIdInfo': {'id': 'OTT329/305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'OT329 Solis', 'description': 'OT329 Solis (twice daily inhalation throughout the study)', 'interventionNames': ['Drug: OT329 (combination of fluticasone propionate and salmeterol xinafoate)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Advair Diskus', 'description': 'Advair Diskus (twice daily inhalation throughout the study)', 'interventionNames': ['Drug: Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo (twice daily inhalation throughout the study)', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'OT329 (combination of fluticasone propionate and salmeterol xinafoate)', 'type': 'DRUG', 'description': 'Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Solis dry powder inhaler', 'armGroupLabels': ['OT329 Solis']}, {'name': 'Advair Diskus (combination of fluticasone propionate and salmeterol xinafoate)', 'type': 'DRUG', 'description': 'Fluticasone propionate (100 mcg) and salmeterol xinafoate (50 mcg) administered by Diskus dry powder inhaler', 'armGroupLabels': ['Advair Diskus']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo (lactose) administered via the Solis dry powder inhaler', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85395', 'city': 'Goodyear', 'state': 'Arizona', 'country': 'United States', 'facility': 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