Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-11 @ 5:07 PM
Study NCT ID:
NCT02105012
Status:
COMPLETED
Last Update Posted:
2017-06-06
First Post:
2014-04-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], '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'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pdorinsky@pearltherapeutics.com', 'phone': '650-305-2600', 'title': 'Paul Dorinsky, MD, FCCP', 'organization': 'Pearl Therapeutics Inc.'}, 'certainAgreement': {'otherDetails': 'Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were recorded from the time subjects received their first dose of study medication, during the entire study period, and up to 14 days from the date of the last study medication dose.', 'description': 'The Safety population was defined as all subjects who were randomized to treatment and received at least 1 dose of the study treatment. Subjects in the Safety population were analyzed according to the treatment received.', 'eventGroups': [{'id': 'EG000', 'title': 'BD MDI 320 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg', 'otherNumAtRisk': 124, 'otherNumAffected': 7, 'seriousNumAtRisk': 124, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'BD MDI 160 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg', 'otherNumAtRisk': 132, 'otherNumAffected': 7, 'seriousNumAtRisk': 132, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'BD MDI 80 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg', 'otherNumAtRisk': 64, 'otherNumAffected': 1, 'seriousNumAtRisk': 64, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'BD MDI 40 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg', 'otherNumAtRisk': 63, 'otherNumAffected': 2, 'seriousNumAtRisk': 63, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Placebo MDI', 'description': 'Placebo MDI.', 'otherNumAtRisk': 127, 'otherNumAffected': 12, 'seriousNumAtRisk': 127, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 127, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 127, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 124, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 132, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 64, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 63, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 127, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '2'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '109', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '111', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BD MDI 320 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg'}, {'id': 'OG001', 'title': 'BD MDI 160 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg'}, {'id': 'OG002', 'title': 'BD MDI 80 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg'}, {'id': 'OG003', 'title': 'BD MDI 40 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg'}, {'id': 'OG004', 'title': 'Placebo MDI', 'description': 'Placebo MDI.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.002', 'groupId': 'OG000', 'lowerLimit': '-0.036', 'upperLimit': '0.033'}, {'value': '-0.001', 'groupId': 'OG001', 'lowerLimit': '-0.035', 'upperLimit': '0.033'}, {'value': '-0.034', 'groupId': 'OG002', 'lowerLimit': '-0.081', 'upperLimit': '0.014'}, {'value': '-0.031', 'groupId': 'OG003', 'lowerLimit': '-0.079', 'upperLimit': '0.016'}, {'value': '-0.116', 'groupId': 'OG004', 'lowerLimit': '-0.150', 'upperLimit': '-0.082'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)', 'description': 'Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent to Treat Population (MITT)'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '107', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '50', 'groupId': 'OG003'}, {'value': '107', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BD MDI 320 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg'}, {'id': 'OG001', 'title': 'BD MDI 160 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg'}, {'id': 'OG002', 'title': 'BD MDI 80 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg'}, {'id': 'OG003', 'title': 'BD MDI 40 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg'}, {'id': 'OG004', 'title': 'Placebo MDI', 'description': 'Placebo MDI.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.802', 'groupId': 'OG000', 'lowerLimit': '-17.937', 'upperLimit': '6.333'}, {'value': '-7.461', 'groupId': 'OG001', 'lowerLimit': '-19.536', 'upperLimit': '4.614'}, {'value': '-9.992', 'groupId': 'OG002', 'lowerLimit': '-24.293', 'upperLimit': '4.309'}, {'value': '-5.653', 'groupId': 'OG003', 'lowerLimit': '-20.320', 'upperLimit': '9.014'}, {'value': '-29.933', 'groupId': 'OG004', 'lowerLimit': '-42.019', 'upperLimit': '-17.847'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Last 7 Days of Treatment Period', 'description': 'Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)', 'unitOfMeasure': 'Liters/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '108', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '52', 'groupId': 'OG003'}, {'value': '110', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BD MDI 320 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg'}, {'id': 'OG001', 'title': 'BD MDI 160 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg'}, {'id': 'OG002', 'title': 'BD MDI 80 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg'}, {'id': 'OG003', 'title': 'BD MDI 40 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg'}, {'id': 'OG004', 'title': 'Placebo MDI', 'description': 'Placebo MDI.'}], 'classes': [{'categories': [{'measurements': [{'value': '-7.345', 'groupId': 'OG000', 'lowerLimit': '-18.394', 'upperLimit': '3.703'}, {'value': '-11.791', 'groupId': 'OG001', 'lowerLimit': '-22.737', 'upperLimit': '-0.844'}, {'value': '-14.403', 'groupId': 'OG002', 'lowerLimit': '-28.118', 'upperLimit': '-0.688'}, {'value': '-1.896', 'groupId': 'OG003', 'lowerLimit': '-15.585', 'upperLimit': '11.793'}, {'value': '-32.807', 'groupId': 'OG004', 'lowerLimit': '-43.712', 'upperLimit': '-21.902'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Last 7 Days of Treatment Period', 'description': 'Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)', 'unitOfMeasure': 'Liters/min', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA', 'denoms': [{'units': 'Participants', 'counts': [{'value': '111', 'groupId': 'OG000'}, {'value': '115', 'groupId': 'OG001'}, {'value': '56', 'groupId': 'OG002'}, {'value': '56', 'groupId': 'OG003'}, {'value': '114', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BD MDI 320 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg'}, {'id': 'OG001', 'title': 'BD MDI 160 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg'}, {'id': 'OG002', 'title': 'BD MDI 80 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg'}, {'id': 'OG003', 'title': 'BD MDI 40 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg'}, {'id': 'OG004', 'title': 'Placebo MDI', 'description': 'Placebo MDI.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.140', 'groupId': 'OG000', 'lowerLimit': '-0.531', 'upperLimit': '0.251'}, {'value': '-0.268', 'groupId': 'OG001', 'lowerLimit': '-0.654', 'upperLimit': '0.119'}, {'value': '-0.312', 'groupId': 'OG002', 'lowerLimit': '-0.810', 'upperLimit': '0.186'}, {'value': '-0.095', 'groupId': 'OG003', 'lowerLimit': '-0.592', 'upperLimit': '0.402'}, {'value': '0.606', 'groupId': 'OG004', 'lowerLimit': '0.218', 'upperLimit': '0.994'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Last 7 Days of Treatment', 'description': 'Change from baseline in mean number of puffs of rescue Ventolin HFA', 'unitOfMeasure': 'Puffs/Day', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}, {'value': '114', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}, {'value': '115', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'BD MDI 320 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 320 µg'}, {'id': 'OG001', 'title': 'BD MDI 160 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 160 µg'}, {'id': 'OG002', 'title': 'BD MDI 80 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 80 µg'}, {'id': 'OG003', 'title': 'BD MDI 40 µg', 'description': 'Budesonide (BD) Metered Dose Inhaler (MDI) 40 µg'}, {'id': 'OG004', 'title': 'Placebo MDI', 'description': 'Placebo MDI.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.575', 'groupId': 'OG000', 'lowerLimit': '-0.730', 'upperLimit': '-0.420'}, {'value': '-0.565', 'groupId': 'OG001', 'lowerLimit': '-0.717', 'upperLimit': '-0.412'}, {'value': '-0.515', 'groupId': 'OG002', 'lowerLimit': '-0.714', 'upperLimit': '-0.317'}, {'value': '-0.407', 'groupId': 'OG003', 'lowerLimit': '-0.605', 'upperLimit': '-0.209'}, {'value': '-0.100', 'groupId': 'OG004', 'lowerLimit': '-0.252', 'upperLimit': '0.052'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)', 'description': 'The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Subjects'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '147'}]}, {'type': 'BD MDI 320 µg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '124'}]}, {'type': 'BD MDI 160 µg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '132'}]}, {'type': 'BD MDI 80 µg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '64'}]}, {'type': 'BD MDI 40 µg', 'achievements': [{'groupId': 'FG000', 'numSubjects': '63'}]}, {'type': 'Placebo MDI', 'achievements': [{'groupId': 'FG000', 'numSubjects': '127'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '114'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Protocol Specified Criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '9'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Conducted at 44 sites in the US from May 2015 to September 2015. Study participation maximum of 32 weeks.', 'preAssignmentDetails': 'A Randomized, Double-Blind, Chronic Dosing (4 Weeks), Four-Period, Five-Treatment, Incomplete Block, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Four Doses of Budesonide Inhalation Aerosol (BD MDI, PT008) Relative to Placebo MDI in Adult Subjects With Mild to Moderate Persistent Asthma'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '147', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Subjects'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '11.2', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '102', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '45', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'Double Blind'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 147}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2015-09-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-05-05', 'studyFirstSubmitDate': '2014-04-02', 'resultsFirstSubmitDate': '2016-10-31', 'studyFirstSubmitQcDate': '2014-04-04', 'lastUpdatePostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-05-05', 'studyFirstPostDateStruct': {'date': '2014-04-07', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Morning Pre-dose Trough Forced Expiratory Volume in 1 Second (FEV1) at the End of the Treatment Period', 'timeFrame': 'Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)', 'description': 'Change from baseline in morning pre-dose trough Forced Expiratory Volume in 1 second (FEV1) at the end of the Treatment Period.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)', 'timeFrame': 'Baseline to Last 7 Days of Treatment Period', 'description': 'Change From Baseline in Mean Morning Pre-dose Diary Peak Expiratory Flow Rate (PEFR)'}, {'measure': 'Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)', 'timeFrame': 'Baseline to Last 7 Days of Treatment Period', 'description': 'Change From Baseline in Mean Evening Pre-dose Diary Peak Expiratory Flow Rate (PEFR)'}, {'measure': 'Change From Baseline in Mean Number of Puffs of Rescue Ventolin HFA', 'timeFrame': 'Baseline to Last 7 Days of Treatment', 'description': 'Change from baseline in mean number of puffs of rescue Ventolin HFA'}, {'measure': 'Change From Baseline in Asthma Control Questionnaire (ACQ-5) Score', 'timeFrame': 'Baseline to End of Treatment Period (Day 29 or Day 15 if Day 29 is missing)', 'description': 'The ACQ-5 measures 5 symptoms (woken at night by symptoms, wake in the morning with symptoms, limitation of daily activities, shortness of breath, and wheeze). The scale is 0-6, where 0=minimum and 6=maximum'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Mild', 'moderate persistent', 'Adult'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'Study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.', 'detailedDescription': 'This is a randomized, double-blind, chronic dosing (4 weeks), four-period, five-treatment, incomplete block, cross-over, multicenter study to assess the efficacy and safety of four doses of budesonide inhalation aerosol (BD MDI, PT008) relative to placebo MDI in adult subjects with mild to moderate persistent asthma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥ 18 - 65 years of age\n* Diagnosis of mild to moderate persistent asthma, diagnosed at least 6 months prior to screening\n* Currently receiving treatment with a low to medium dose of an inhaled corticosteroid (ICS) OR a combination of controller medications for at least 4 weeks preceding screening\n* Pre-albuterol FEV1 of \\> 60% and \\< 85% of predicted normal value\n* Reversibility: Increase in FEV1 of ≥ 12% and ≥ 200 mL over the pre-albuterol FEV1 within 30 - 60 minutes after the inhalation of 4 puffs of Ventolin hydrofluoroalkane (HFA)\n* Asthma Symptom Criteria: Have required albuterol use on at least two of the last seven days and have an Asthma Control Questionnaire (ACQ) total score ≥ 1.5 prior to Randomization\n\nExclusion Criteria:\n\n* Life-Threatening Asthma: A subject must not have life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within the 12 months prior to screening\n* Worsening of Asthma: A subject must not have experienced a worsening of asthma which involved an emergency department visit, hospitalization or use of oral/parenteral corticosteroids within 6 weeks of screening\n* Intermittent, Seasonal, or Exercise-Induced Asthma Alone: Subjects with only intermittent, seasonal or exercise-induced asthma are excluded from participation in this study\n* Concurrent Respiratory Disease\n* Pregnant women or nursing mothers\n* A current diagnosis of Chronic Obstructive Pulmonary Disease (COPD\n* Current smokers or subjects with a \\> 10 pack year history of cigarettes, cigars, or pipe smoking\n* Respiratory tract infection within 6 weeks prior to Visit 1\n* Subjects with documented myocardial infarction within a year from screening visit\n* Clinically significant abnormal ECG\n* Abnormal liver function tests defined as aspartate aminotransferase (AST), alanine aminotransferace (ALT), alkaline phosphatase or total bilirubin ≥ 1.5 times upper limit of normal on repeat testing\n* Subjects who have cancer that has not been in complete remission for at least 5 years\n* Drug Allergy: Subjects who have a history of hypersensitivity to any component of the metered-dose inhaler (MDI)'}, 'identificationModule': {'nctId': 'NCT02105012', 'briefTitle': 'Study to Assess the Efficacy and Safety of Budesonide (PT008) in Adult Subjects With Mild to Moderate Persistent Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pearl Therapeutics, Inc.'}, 'officialTitle': 'Randomized, Double-Blind, Chronic Dosing (4 Weeks), Four-Period, Five-Treatment, Incomplete Block, Cross-Over, Multi-Center Study to Assess the Efficacy and Safety of Four Doses of Budesonide Inhalation Aerosol (BD MDI, PT008) Relative to Placebo MDI in Adult Subjects With Mild to Moderate Persistent Asthma', 'orgStudyIdInfo': {'id': 'PT008001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BD MDI 320 µg', 'description': 'Budesonide metered dose inhaler (BD MDI) 320 µg (PT008) administered as 2 inhalations BID', 'interventionNames': ['Drug: BD MDI 320 µg']}, {'type': 'EXPERIMENTAL', 'label': 'BD MDI 160 µg', 'description': 'BD MDI 160 µg (PT008) administered as 2 inhalations BID', 'interventionNames': ['Drug: BD MDI 160 µg']}, {'type': 'EXPERIMENTAL', 'label': 'BD MDI 80 µg', 'description': 'BD MDI 80 µg (PT008) administered as 2 inhalations BID', 'interventionNames': ['Drug: BD MDI 80 µg']}, {'type': 'EXPERIMENTAL', 'label': 'BD MDI 40 µg', 'description': 'BD MDI 40 µg (PT008) administered as 2 inhalations BID', 'interventionNames': ['Drug: BD MDI 40 µg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MDI', 'description': 'Placebo MDI administered as 2 inhalations BID', 'interventionNames': ['Drug: Placebo MDI']}], 'interventions': [{'name': 'BD MDI 320 µg', 'type': 'DRUG', 'otherNames': ['PT008'], 'description': 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