Viewing Study NCT04600505

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Ignite Creation Date: 2025-12-25 @ 3:30 AM
Ignite Modification Date: 2025-12-26 @ 2:12 AM
Study NCT ID: NCT04600505
Status: COMPLETED
Last Update Posted: 2023-01-23
First Post: 2020-10-19
Is NOT Gene Therapy: False
Has Adverse Events: True
Brief Title: A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '1-877-240-9479', 'title': 'Global Clinical Head', 'organization': 'AstraZeneca Clinical Study Information Center'}, 'certainAgreement': {'otherDetails': 'No unpublished information may be disclosed without prior written approval from AstraZeneca AB.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Screening, Day -1 until Follow-up visit, up to 53 days', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment A', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 9, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment B', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 10, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment C', 'description': 'Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)', 'otherNumAtRisk': 47, 'deathsNumAtRisk': 47, 'otherNumAffected': 10, 'seriousNumAtRisk': 47, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Dry throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Nasal congestion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Productive cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Sputum increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Throat irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Throat tightness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Upper-airway cough syndrome', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Medical device site dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Chills', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Abdominal distension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Dry mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Abnormal dreams', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Nightmare', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Hypermetropia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Bone pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Testicular pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 47, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 47, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 47, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 23.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Concentration (Cmax) of BGF MDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)'}], 'classes': [{'title': 'Budesonide', 'categories': [{'measurements': [{'value': '552.2', 'spread': '54.74', 'groupId': 'OG000'}, {'value': '483.2', 'spread': '48.43', 'groupId': 'OG001'}, {'value': '489.4', 'spread': '61.61', 'groupId': 'OG002'}]}]}, {'title': 'Glycopyrronium', 'categories': [{'measurements': [{'value': '11.74', 'spread': '72.16', 'groupId': 'OG000'}, {'value': '10.19', 'spread': '58.42', 'groupId': 'OG001'}, {'value': '10.76', 'spread': '70.78', 'groupId': 'OG002'}]}]}, {'title': 'Formoterol', 'categories': [{'measurements': [{'value': '12.70', 'spread': '50.52', 'groupId': 'OG000'}, {'value': '11.68', 'spread': '47.22', 'groupId': 'OG001'}, {'value': '11.48', 'spread': '52.95', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '111.7', 'ciLowerLimit': '91.01', 'ciUpperLimit': '137.1', 'groupDescription': 'Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.78', 'ciLowerLimit': '78.67', 'ciUpperLimit': '124.0', 'groupDescription': 'Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '108.3', 'ciLowerLimit': '85.50', 'ciUpperLimit': '137.3', 'groupDescription': 'Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '94.88', 'ciLowerLimit': '74.69', 'ciUpperLimit': '120.5', 'groupDescription': 'Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '109.1', 'ciLowerLimit': '97.02', 'ciUpperLimit': '122.7', 'groupDescription': 'Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciPctValue': '90', 'paramValue': '100.1', 'ciLowerLimit': '83.78', 'ciUpperLimit': '119.5', 'groupDescription': 'Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Evaluation of the relative bioavailability between the test formulations and the reference formulation for fixed dose combinations (FDCs) of BGF when delivered as BGF MDI with 3 different propellants by Cmax.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of BGF MDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)'}], 'classes': [{'title': 'Budesonide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2454', 'spread': '36.76', 'groupId': 'OG000'}, {'value': '2262', 'spread': '32.27', 'groupId': 'OG001'}, {'value': '2314', 'spread': '45.60', 'groupId': 'OG002'}]}]}, {'title': 'Glycopyrronium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '30.32', 'spread': '39.74', 'groupId': 'OG000'}, {'value': '27.23', 'spread': '30.67', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Three values were required as a minimum for PK parameters to be summarized as per protocol.', 'groupId': 'OG002'}]}]}, {'title': 'Formoterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '93.68', 'spread': '35.71', 'groupId': 'OG000'}, {'value': '115.1', 'spread': '30.99', 'groupId': 'OG001'}, {'value': '92.84', 'spread': '30.45', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '104.7', 'ciLowerLimit': '91.95', 'ciUpperLimit': '119.2', 'groupDescription': 'Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.03', 'ciLowerLimit': '83.33', 'ciUpperLimit': '115.3', 'groupDescription': 'Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciPctValue': '90', 'paramValue': '96.00', 'ciLowerLimit': '70.33', 'ciUpperLimit': '131.0', 'groupDescription': 'Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciPctValue': '90', 'paramValue': '116.7', 'ciLowerLimit': '86.31', 'ciUpperLimit': '157.8', 'groupDescription': 'Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Evaluation of the relative bioavailability between the test formulations and the reference formulation for FDCs of BGF when delivered as BGF MDI with 3 different propellants by AUCinf.', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.'}, {'type': 'PRIMARY', 'title': 'Area Under the Plasma Concentration- Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of BGF MDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)'}], 'classes': [{'title': 'Budesonide', 'categories': [{'measurements': [{'value': '2391', 'spread': '36.77', 'groupId': 'OG000'}, {'value': '2197', 'spread': '32.81', 'groupId': 'OG001'}, {'value': '2232', 'spread': '44.14', 'groupId': 'OG002'}]}]}, {'title': 'Glycopyrronium', 'categories': [{'measurements': [{'value': '29.87', 'spread': '88.09', 'groupId': 'OG000'}, {'value': '28.63', 'spread': '53.90', 'groupId': 'OG001'}, {'value': '29.20', 'spread': '82.24', 'groupId': 'OG002'}]}]}, {'title': 'Formoterol', 'categories': [{'measurements': [{'value': '66.17', 'spread': '50.54', 'groupId': 'OG000'}, {'value': '74.34', 'spread': '41.35', 'groupId': 'OG001'}, {'value': '67.82', 'spread': '55.58', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '107.3', 'ciLowerLimit': '94.53', 'ciUpperLimit': '121.9', 'groupDescription': 'Statistical Comparison of Budesonide PK Parameters for Treatment A (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.80', 'ciLowerLimit': '84.59', 'ciUpperLimit': '115.4', 'groupDescription': 'Statistical Comparison of Budesonide PK Parameters for Treatment B (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '106.1', 'ciLowerLimit': '86.18', 'ciUpperLimit': '130.6', 'groupDescription': 'Statistical Comparison of Glycopyrronium PK Parameters for Treatment A (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '99.71', 'ciLowerLimit': '80.84', 'ciUpperLimit': '123.0', 'groupDescription': 'Statistical Comparison of Glycopyrronium PK Parameters for Treatment B (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG000', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '98.13', 'ciLowerLimit': '86.44', 'ciUpperLimit': '111.4', 'groupDescription': 'Statistical Comparison of Formoterol PK Parameters for Treatment A (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}, {'groupIds': ['OG001', 'OG002'], 'paramType': 'Geometric mean Ratio (%)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '107.0', 'ciLowerLimit': '88.82', 'ciUpperLimit': '128.9', 'groupDescription': 'Statistical Comparison of Formoterol PK Parameters for Treatment B (test) versus Treatment C (reference)', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Results based on linear mixed-effects analysis of variance model'}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Evaluation of the relative bioavailability between the test formulations and the reference formulation for FDCs of BGF when delivered as BGF MDI with 3 different propellants by AUClast.', 'unitOfMeasure': 'h*pg/mL', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.'}, {'type': 'SECONDARY', 'title': 'Time to Reach Maximum Observed Concentration (Tmax) of BGF MDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '23', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)'}], 'classes': [{'title': 'Budesonide', 'categories': [{'measurements': [{'value': '0.50', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '2.00'}, {'value': '0.75', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '2.00'}, {'value': '0.52', 'groupId': 'OG002', 'lowerLimit': '0.08', 'upperLimit': '1.02'}]}]}, {'title': 'Glycopyrronium', 'categories': [{'measurements': [{'value': '0.08', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.75'}, {'value': '0.08', 'groupId': 'OG001', 'lowerLimit': '0.03', 'upperLimit': '2.00'}, {'value': '0.08', 'groupId': 'OG002', 'lowerLimit': '0.03', 'upperLimit': '2.00'}]}]}, {'title': 'Formoterol', 'categories': [{'measurements': [{'value': '0.17', 'groupId': 'OG000', 'lowerLimit': '0.08', 'upperLimit': '2.00'}, {'value': '0.50', 'groupId': 'OG001', 'lowerLimit': '0.08', 'upperLimit': '2.00'}, {'value': '0.17', 'groupId': 'OG002', 'lowerLimit': '0.07', 'upperLimit': '2.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Assessment of tmax of BGF when administered as 3 different propellant formulations.', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.'}, {'type': 'SECONDARY', 'title': 'Terminal Elimination Half-life (t½λz) of BGF MDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)'}], 'classes': [{'title': 'Budesonide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.420', 'spread': '0.4003', 'groupId': 'OG000'}, {'value': '4.438', 'spread': '0.7886', 'groupId': 'OG001'}, {'value': '4.574', 'spread': '0.4267', 'groupId': 'OG002'}]}]}, {'title': 'Glycopyrronium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Formoterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': 'NA', 'spread': 'NA', 'comment': 'Three values were required as a minimum for PK parameters to be summarized as per protocol.', 'groupId': 'OG000'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Three values were required as a minimum for PK parameters to be summarized as per protocol.', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Assessment of t½λz of BGF when administered as 3 different propellant formulations.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.'}, {'type': 'SECONDARY', 'title': 'Apparent Total Body Clearance of Drug After Extravascular Administration (CL/F) of BGF MDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)'}], 'classes': [{'title': 'Budesonide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '137.9', 'spread': '43.28', 'groupId': 'OG000'}, {'value': '148.6', 'spread': '50.91', 'groupId': 'OG001'}, {'value': '155.3', 'spread': '105.4', 'groupId': 'OG002'}]}]}, {'title': 'Glycopyrronium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '502.6', 'spread': '201.8', 'groupId': 'OG000'}, {'value': '544.5', 'spread': '158.1', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Three values were required as a minimum for PK parameters to be summarized as per protocol.', 'groupId': 'OG002'}]}]}, {'title': 'Formoterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '108.8', 'spread': '43.64', 'groupId': 'OG000'}, {'value': '87.14', 'spread': '32.16', 'groupId': 'OG001'}, {'value': '108.3', 'spread': '38.41', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Assessment of CL/F of BGF when administered as 3 different propellant formulations.', 'unitOfMeasure': 'Litre/hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.'}, {'type': 'SECONDARY', 'title': 'Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of BGF MDI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)'}], 'classes': [{'title': 'Budesonide', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '941.9', 'spread': '328.6', 'groupId': 'OG000'}, {'value': '1023', 'spread': '330.4', 'groupId': 'OG001'}, {'value': '1142', 'spread': '1005', 'groupId': 'OG002'}]}]}, {'title': 'Glycopyrronium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1992', 'spread': '200.5', 'groupId': 'OG000'}, {'value': '2079', 'spread': '638.9', 'groupId': 'OG001'}, {'value': 'NA', 'spread': 'NA', 'comment': 'Three values were required as a minimum for PK parameters to be summarized as per protocol.', 'groupId': 'OG002'}]}]}, {'title': 'Formoterol', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1171', 'spread': '281.2', 'groupId': 'OG000'}, {'value': '1007', 'spread': '211.3', 'groupId': 'OG001'}, {'value': '1167', 'spread': '180.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Assessment of Vz/F of BGF when administered as 3 different propellant formulations.', 'unitOfMeasure': 'Litre', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK Analysis Set consisted of all participants in the Safety Analysis Set for whom at least 1 of the primary PK parameters could have been calculated, and who had no important protocol deviations thought to impact on the analysis of the PK data. Number Analyzed in each row signifies only the participants with available data that were analyzed for BGF MDI.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '47', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment A', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 1 - test formulation (Treatment A)'}, {'id': 'OG001', 'title': 'Treatment B', 'description': 'Participants received 2 inhalations of BGF MDI with Propellant 2 - test formulation (Treatment B)'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Participants received 2 inhalations of BGF MDI with HFA Propellant - reference formulation (Treatment C)'}], 'classes': [{'title': 'Any AE', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}]}, {'title': 'Any AE with outcome = death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any serious AE (including events with outcome = death)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any AE leading to discontinuation of IMP', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Any AE leading to withdrawal from study', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening, Day -1 until Follow-up visit, up to 53 days', 'description': 'Assessment of the safety and tolerability of a combination of BGF when administered as single doses in 3 different propellant formulations in healthy participants.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The Safety Analysis Set included all participants who received at least 1 inhalation of any BGF MDI formulated treatment. This included all original and replacement participants where the 1 inhalation criterion was met.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Sequence ABC', 'description': 'Randomized participants received 3 single-dose treatments of budesonide, glycopyronnium, formoterol (BGF) metered dose inhaler (MDI) (1 dose Propellant 1 \\[Treatment A\\]; 1 dose Propellant 2 \\[Treatment B\\] and 1 dose HFA propellant \\[Treatment C\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}, {'id': 'FG001', 'title': 'Treatment Sequence BCA', 'description': 'Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 2 \\[Treatment B\\]; 1 dose HFA propellant \\[Treatment C\\] and 1 dose Propellant 1 \\[Treatment A\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}, {'id': 'FG002', 'title': 'Treatment Sequence CAB', 'description': 'Randomized participants received 3 single-dose treatments of BGF MDI (1 dose HFA propellant \\[Treatment C\\]; 1 dose Propellant 1 \\[Treatment A\\] and 1 dose Propellant 2 \\[Treatment B\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}, {'id': 'FG003', 'title': 'Treatment Sequence ACB', 'description': 'Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 1 \\[Treatment A\\]; 1 dose HFA propellant \\[Treatment C\\] and 1 dose Propellant 2 \\[Treatment B\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}, {'id': 'FG004', 'title': 'Treatment Sequence BAC', 'description': 'Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 2 \\[Treatment B\\]; 1 dose Propellant 1 \\[Treatment A\\] and 1 dose HFA propellant \\[Treatment C\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}, {'id': 'FG005', 'title': 'Treatment Sequence CBA', 'description': 'Randomized participants received 3 single-dose treatments of BGF MDI (1 dose HFA propellant \\[Treatment C\\]; 1 dose Propellant 2 \\[Treatment B\\] and 1 dose Propellant 1 \\[Treatment A\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'This study was conducted between 19 Oct 2020 to 17 May 2021 at a single study center - Parexel Early Phase Clinical Unit (Los Angeles).', 'preAssignmentDetails': 'This study consisted of a Screening Period of 28 days. There were three treatment periods of maximum three days each, with washout period of 3 to 7 days between each study dose administration. The assessments were done as per the schedule of assessment in the clinical study protocol.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Sequence ABC', 'description': 'Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 1 \\[Treatment A\\]; 1 dose Propellant 2 \\[Treatment B\\] and 1 dose HFA propellant \\[Treatment C\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}, {'id': 'BG001', 'title': 'Treatment Sequence BCA', 'description': 'Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 2 \\[Treatment B\\]; 1 dose HFA propellant \\[Treatment C\\] and 1 dose Propellant 1 \\[Treatment A\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}, {'id': 'BG002', 'title': 'Treatment Sequence CAB', 'description': 'Randomized participants received 3 single-dose treatments of BGF MDI (1 dose HFA propellant \\[Treatment C\\]; 1 dose Propellant 1 \\[Treatment A\\] and 1 dose Propellant 2 \\[Treatment B\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}, {'id': 'BG003', 'title': 'Treatment Sequence ACB', 'description': 'Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 1 \\[Treatment A\\]; 1 dose HFA propellant \\[Treatment C\\] and 1 dose Propellant 2 \\[Treatment B\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}, {'id': 'BG004', 'title': 'Treatment Sequence BAC', 'description': 'Randomized participants received 3 single-dose treatments of BGF MDI (1 dose Propellant 2 \\[Treatment B\\]; 1 dose Propellant 1 \\[Treatment A\\] and 1 dose HFA propellant \\[Treatment C\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}, {'id': 'BG005', 'title': 'Treatment Sequence CBA', 'description': 'Randomized participants received 3 single-dose treatments of BGF MDI (1 dose HFA propellant \\[Treatment C\\]; 1 dose Propellant 2 \\[Treatment B\\] and 1 dose Propellant 1 \\[Treatment A\\]) in 3 treatment periods, with wash-out periods of 3 - 7 days between each study dose administration under fasted conditions.'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '36.0', 'spread': '7.56', 'groupId': 'BG000'}, {'value': '38.5', 'spread': '7.67', 'groupId': 'BG001'}, {'value': '36.6', 'spread': '6.63', 'groupId': 'BG002'}, {'value': '34.4', 'spread': '8.33', 'groupId': 'BG003'}, {'value': '34.7', 'spread': '11.63', 'groupId': 'BG004'}, {'value': '39.1', 'spread': '11.89', 'groupId': 'BG005'}, {'value': '36.6', 'spread': '8.79', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '47', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '6', 'groupId': 'BG005'}, {'value': '36', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'categories': [{'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '22', 'groupId': 'BG006'}]}, {'title': 'Other', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'The Randomized Set consisted of all participants randomized into the study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-05', 'size': 1287777, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-01-21T09:47', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'This is a single blind study with regard to BGF MDI treatment, administered with 3 different propellants (Treatment A, B or C), in which the participants will remain blinded.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-20', 'studyFirstSubmitDate': '2020-10-19', 'resultsFirstSubmitDate': '2022-01-21', 'studyFirstSubmitQcDate': '2020-10-19', 'lastUpdatePostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-04-20', 'studyFirstPostDateStruct': {'date': '2020-10-23', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Concentration (Cmax) of BGF MDI', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Evaluation of the relative bioavailability between the test formulations and the reference formulation for fixed dose combinations (FDCs) of BGF when delivered as BGF MDI with 3 different propellants by Cmax.'}, {'measure': 'Area Under the Concentration-time Curve From Time Zero Extrapolated to Infinity (AUCinf) of BGF MDI', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Evaluation of the relative bioavailability between the test formulations and the reference formulation for FDCs of BGF when delivered as BGF MDI with 3 different propellants by AUCinf.'}, {'measure': 'Area Under the Plasma Concentration- Curve From Time Zero to the Time of Last Quantifiable Concentration (AUClast) of BGF MDI', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Evaluation of the relative bioavailability between the test formulations and the reference formulation for FDCs of BGF when delivered as BGF MDI with 3 different propellants by AUClast.'}], 'secondaryOutcomes': [{'measure': 'Time to Reach Maximum Observed Concentration (Tmax) of BGF MDI', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Assessment of tmax of BGF when administered as 3 different propellant formulations.'}, {'measure': 'Terminal Elimination Half-life (t½λz) of BGF MDI', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Assessment of t½λz of BGF when administered as 3 different propellant formulations.'}, {'measure': 'Apparent Total Body Clearance of Drug After Extravascular Administration (CL/F) of BGF MDI', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Assessment of CL/F of BGF when administered as 3 different propellant formulations.'}, {'measure': 'Apparent Volume of Distribution During the Terminal Phase After Extravascular Administration (Vz/F) of BGF MDI', 'timeFrame': 'Pre-dose and 2, 5, 10, 20, 30, and 45 minutes post-dose and 1, 2, 4, 8, 12 and 24 hours post-dose', 'description': 'Assessment of Vz/F of BGF when administered as 3 different propellant formulations.'}, {'measure': 'Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events', 'timeFrame': 'Screening, Day -1 until Follow-up visit, up to 53 days', 'description': 'Assessment of the safety and tolerability of a combination of BGF when administered as single doses in 3 different propellant formulations in healthy participants.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Budesonide', 'Glycopyrronium', 'Formoterol', 'Hydrofluoroalkane', 'Metered dose inhaler'], 'conditions': ['Chronic Obstructive Pulmonary Disease (COPD)']}, 'referencesModule': {'references': [{'pmid': '37607661', 'type': 'DERIVED', 'citation': 'Aurivillius M, Bednarczyk A, Kokot M, Madriaga J, Mei J, Collison K, Surujbally R, Archbell J, Joshi V, Gillen M. Relative bioavailability of budesonide/glycopyrrolate/formoterol fumarate triple therapy delivered using next generation propellants with low global warming potential. Pulm Pharmacol Ther. 2023 Dec;83:102245. doi: 10.1016/j.pupt.2023.102245. Epub 2023 Aug 20.'}], 'seeAlsoLinks': [{'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5985C00001&amp;attachmentIdentifier=7ae437a9-62d2-4284-bb3d-06a0a615cfeb&amp;fileName=AZ_D5985C00001_(PXL_245780)_CSP.pdf&amp;versionIdentifier=', 'label': 'CSR Synopsis'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&amp;parentIdentifier=D5985C00001&amp;attachmentIdentifier=00cd56e1-4a3c-40f6-93be-f56a6cbd0f64&amp;fileName=AZ_D5985C00001_(PXL_245780)_Final_Protocol_Redacted.pdf&amp;versionIdentifier=', 'label': 'CSP \\& SAP'}]}, 'descriptionModule': {'briefSummary': 'The study will evaluate bioavailability, pharmacokinetics, safety, and tolerability of budesonide, glycopyrronium and formoterol (BGF) metered dose inhaler (MDI) formulated with 3 different propellants: Propellant 1 (Treatment A \\[test\\]), Propellant 2 (Treatment B \\[test\\]) and Hydrofluoroalkane (HFA) (Treatment C \\[reference\\]).', 'detailedDescription': 'The study will comprise:\n\n* Screening period: up to 28 days prior to first dosing;\n* Three treatment periods of maximum 3 days each: participants will be resident from the morning of the day before the first dosing with BGF MDI (Day -1) in Treatment Period 1, throughout all treatment and washout periods up to discharge on Day 2 of Treatment Period 3;\n* Follow-up: within 3 to 7 days after the last administration of BGF MDI. There will be a washout period of 3 to 7 days between each dose.\n\nEach participant will receive 3 single-dose treatments of BGF MDI (1 dose Propellant 1 \\[Treatment A\\]; 1 dose Propellant 2 \\[Treatment B\\] and 1 dose HFA \\[Treatment C\\]), following an overnight fast of at least 8 hours. Each participant will be involved in the study for up to 53 days.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Provision of signed and dated, written informed consent prior to any study specific procedures.\n* Non-smoking male participants with suitable veins for cannulation or repeated venipuncture.\n* Participants must agree to follow the reproductive restrictions.\n* Have a body mass index between 18 and 30 kg/m\\^2 and weigh at least 50 kg and no more than 100 kg.\n* Participants must have a forced expiratory volume in one second ≥ 80% of the predicted value regarding age, height, and ethnicity at the screening visit.\n\nExclusion Criteria:\n\n* History or current evidence of a clinically significant (CS) disease or disorder (including but not limited to cardiovascular, hepatic, renal, hematological, neurological, endocrine, gastrointestinal, or pulmonary).\n* History or presence of gastrointestinal, hepatic or renal disease, or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs.\n* Any CS illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational medicinal product (IMP).\n* Narrow angle glaucoma not adequately treated. All medications approved for control of intraocular pressures are allowed, including topical ophthalmic non-selective β-blockers.\n* Symptomatic prostatic hypertrophy or bladder neck obstruction/urinary retention that, in the opinion of the principal investigator (PI), is CS.\n* Any cancer except squamous cell and basal cell carcinomas of the skin are allowed in the study.\n* Any CS abnormalities in clinical chemistry, hematology, or urinalysis results, at screening and/or admission to the Clinical Unit:\n\n 1. Systolic blood pressure (BP) \\< 90 mmHg or \\> 140 mmHg.\n 2. Diastolic BP \\< 50 mmHg or \\> 90 mmHg.\n 3. Heart rate \\< 45 or \\> 85 bpm.\n* Any CS abnormal findings in vital signs, after 5 minutes supine rest, at screening and/or Day -1 of each Treatment Period, as judged by the PI.\n* Any clinically important abnormalities in rhythm, conduction or morphology of the resting electrocardiogram (ECG) and any clinically important abnormalities in the 12-lead ECG as considered by the PI.\n* Any positive result on screening for serum hepatitis B surface antigen, hepatitis C antibody, and human immunodeficiency virus antibody.\n* Known or suspected history of drug abuse.\n* Participant has a positive reverse transcription polymerase chain reaction test for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) prior to randomization.\n* Participant has clinical signs and symptoms consistent with SARS-CoV-2 infection (e.g., fever, dry cough, dyspnea, sore throat, fatigue, or laboratory confirmed acute infection with SARS-CoV-2).\n* Participant who had severe course of coronavirus disease 2019 (COVID-19).\n* Recent (within 14 days prior to admission to the Clinical Unit) exposure to someone who has COVID-19 symptoms or tested positive for SARS-CoV-2.\n* Recent (within 14 days prior to admission to the Clinical Unit) visit to a healthcare facility where COVID-19 patients are being treated.\n* Has a current occupation that involves routine exposure to potential COVID-19 patients or sources of SARS-CoV-2 infection.\n* Has received another new chemical entity (defined as a compound which has not been approved for marketing) within 3 months of the first administration of IMP in this study.\n* Plasma donation within 1 month of screening or any blood donation/loss more than 500 mL during the 3 months prior to screening.\n* History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, or history of hypersensitivity to drugs with a similar chemical structure or class to BGF.\n* Current smokers or those who have smoked or used nicotine products (including e-cigarettes) within the 3 months prior to screening.\n* Positive screen for drugs of abuse or cotinine at screening or on admission to the Clinical Unit or positive screen for alcohol at screening or on admission to the Clinical Unit.\n* Use of drugs with enzyme-inducing properties such as St John's Wort within 3 weeks prior to the first administration of IMP.\n* Use of any prescribed or non-prescribed medication including antacids, analgesics, herbal remedies, megadose vitamins and minerals during the 2 weeks prior to the first administration of IMP or longer if the medication has a long half-life.\n* Known or suspected history of alcohol abuse or excessive intake of alcohol.\n* Participants who have previously received BGF.\n* Judgment by the PI that the participant should not participate in the study if they have any ongoing or recent minor medical complaints that may interfere with the interpretation of study data or are considered unlikely to comply with study procedures, restrictions, and requirements.\n* Vulnerable participants, eg, kept in detention, protected adults under guardianship, trusteeship, or committed to an institution by governmental or juridical order.\n* History of any respiratory disorders such as asthma, COPD or idiopathic pulmonary fibrosis.\n* Participants who cannot use an inhaler appropriately.\n* Participants who cannot communicate reliably with the PI.\n* Receipt of COVID-19 vaccine (regardless of vaccine delivery platform, eg vector, lipid nanoparticle) less than 7 days prior to the date of randomization (from last vaccination or booster dose)."}, 'identificationModule': {'nctId': 'NCT04600505', 'briefTitle': 'A Study to Assess Drug Absorption of Fixed Dose Combinations of Budesonide, Glycopyrronium, and Formoterol', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Randomized, Single Blind, 3-Period, 3-Treatment, Single-dose, Crossover Study to Assess the Relative Bioavailability of BGF Propellant 1 and BGF Propellant 2 Compared With BGF MDI HFA in Healthy Subjects', 'orgStudyIdInfo': {'id': 'D5985C00001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence ABC', 'description': 'Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment A; Treatment B; Treatment C) in 3 treatment periods, with first dose on Day -1 for all treatment periods.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence BCA', 'description': 'Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment B; Treatment C; Treatment A) in 3 treatment periods, with first dose on Day -1 for all treatment periods.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence CAB', 'description': 'Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment C; Treatment A; Treatment B) in 3 treatment periods, with first dose on Day -1 for all treatment periods.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence ACB', 'description': 'Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment A; Treatment C; Treatment B) in 3 treatment periods, with first dose on Day -1 for all treatment periods.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence BAC', 'description': 'Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment B; Treatment A; Treatment C) in 3 treatment periods, with first dose on Day -1 for all treatment periods.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment Sequence CBA', 'description': 'Participants will be randomized to one of the 6 different treatment sequences. Each participant will receive 3 single-dose treatments of BGF MDI (Treatment C; Treatment B; Treatment A) in 3 treatment periods, with first dose on Day -1 for all treatment periods.', 'interventionNames': ['Drug: Treatment A', 'Drug: Treatment B', 'Drug: Treatment C']}], 'interventions': [{'name': 'Treatment A', 'type': 'DRUG', 'otherNames': ['BGF MDI Propellant 1'], 'description': 'Participants will receive 2 inhalations of BGF MDI with propellant 1.', 'armGroupLabels': ['Treatment Sequence ABC', 'Treatment Sequence ACB', 'Treatment Sequence BAC', 'Treatment Sequence BCA', 'Treatment Sequence CAB', 'Treatment Sequence CBA']}, {'name': 'Treatment B', 'type': 'DRUG', 'otherNames': ['BGF MDI Propellant 2'], 'description': 'Participants will receive 2 inhalations of BGF MDI with propellant 2.', 'armGroupLabels': ['Treatment Sequence ABC', 'Treatment Sequence ACB', 'Treatment Sequence BAC', 'Treatment Sequence BCA', 'Treatment Sequence CAB', 'Treatment Sequence CBA']}, {'name': 'Treatment C', 'type': 'DRUG', 'otherNames': ['BGF MDI HFA'], 'description': 'Participants will receive 2 inhalations of BGF MDI with HFA propellant.', 'armGroupLabels': ['Treatment Sequence ABC', 'Treatment Sequence ACB', 'Treatment Sequence BAC', 'Treatment Sequence BCA', 'Treatment Sequence CAB', 'Treatment Sequence CBA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91206', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}], 'overallOfficials': [{'name': 'David Han, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'PAREXEL Early Phase Clinical Unit-Los Angeles'}]}, 'ipdSharingStatementModule': {'url': 'https://astrazenecagroup-dt.pharmacm.com/DT/Home', 'timeFrame': 'AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please refer to our disclosure commitment at:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All requests will be evaluated as per the AZ disclosure commitment:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.\n\nYes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool. Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at:\n\nhttps://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Parexel', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}