Ignite Creation Date:
2025-12-24 @ 3:00 PM
Ignite Modification Date:
2026-02-11 @ 2:58 AM
Study NCT ID:
NCT03015259
Status:
COMPLETED
Last Update Posted:
2022-08-24
First Post:
2017-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019819', 'term': 'Budesonide'}, {'id': 'D000069502', 'term': 'Budesonide, Formoterol Fumarate Drug Combination'}], 'ancestors': [{'id': 'D011282', 'term': 'Pregnenediones'}, {'id': 'D011283', 'term': 'Pregnenes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D000068759', 'term': 'Formoterol Fumarate'}, {'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D004338', 'term': 'Drug Combinations'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'lester.harrison@kindevadd.com', 'phone': '6122714814', 'title': 'Lester Harrison, PhD', 'organization': 'KINDEVA DRUG DELIVERY'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'There were no limitations to the trial protocol, no early termination or technical problems.'}}, 'adverseEventsModule': {'timeFrame': 'Day 1 - Day 70', 'description': 'Subjects who received at least 1 dose during the Treatment Period (Safety Population).', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment 1', 'description': 'Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nBudesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1', 'otherNumAtRisk': 613, 'deathsNumAtRisk': 613, 'otherNumAffected': 121, 'seriousNumAtRisk': 613, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Treatment 2', 'description': 'Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nSymbicort: Active Comparator: Treatment 2', 'otherNumAtRisk': 622, 'deathsNumAtRisk': 622, 'otherNumAffected': 138, 'seriousNumAtRisk': 622, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'Treatment 3', 'description': 'Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nPlacebo: Placebo Comparator: Treatment 3', 'otherNumAtRisk': 204, 'deathsNumAtRisk': 204, 'otherNumAffected': 71, 'seriousNumAtRisk': 204, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 15, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 18, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 28, 'numAffected': 24}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 48, 'numAffected': 39}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'gastrointestinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 13, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 12, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 4, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'injury, poisoning and procedural complications', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 17, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'nervous system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 12, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 7, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'infections and infestations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 58, 'numAffected': 54}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 61, 'numAffected': 58}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 21, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'respiratory, thoracic and mediastinal disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 40, 'numAffected': 35}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 56, 'numAffected': 48}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 64, 'numAffected': 48}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'musculoskeletal and connective tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 11, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 15, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'investigations', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'general disorders and administration site conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'chest discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'metabolism and nutrition disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'skin and subcutaneous tissue disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'cardia disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'immune system disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'psychiatric disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'vascular disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'ear and labyrinth disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'eye disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'pregnancy, puerperium, and perinatal conditions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'renal and urinary disorders', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'seriousEvents': [{'term': 'cerebrospinal fluid leakage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'staphylococcal skin infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Alcoholic pancreatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Myositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Head injurt', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}, {'term': 'Intervertebral disc protrusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 613, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 622, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 204, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (19.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Area Under the Serial Forced Expiratory Volume in 1 Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}, {'value': '604', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nBudesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nSymbicort: Active Comparator: Treatment 2'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nPlacebo: Placebo Comparator: Treatment 3'}], 'classes': [{'categories': [{'measurements': [{'value': '4.4453', 'spread': '0.1552', 'groupId': 'OG000'}, {'value': '4.2790', 'spread': '0.1547', 'groupId': 'OG001'}, {'value': '1.6876', 'spread': '0.2782', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Test/Referece LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.040', 'ciLowerLimit': '0.958', 'ciUpperLimit': '1.130', 'estimateComment': "Fieller's formula was applied", 'groupDescription': 'Only Treatments 1 and 2 were compared for equivalence. Treatment 3 (placebo) was subtracted from both Treatments 1 and 2, as this primary endpoint was baseline adjusted.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To show the clinical equivalence, an analysis of covariance model was fit on the participants from the test budesonide/formoterol fumarate and Symbicort groups, with the endpoint as outcome and treatment, study site and treatment by site interaction as fixed effects and FEV1 baseline value as covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1', 'description': 'FEV1 Area calculated over 12 hours (measurements at 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose) on Day 1 of treatment. Because this was a primary endpoint, Per Protocol Population used to calculate this endpoint.', 'unitOfMeasure': 'l * hr', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in FEV1 Measured in the Morning at the End of Treatment Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '598', 'groupId': 'OG000'}, {'value': '604', 'groupId': 'OG001'}, {'value': '199', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nBudesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nSymbicort: Active Comparator: Treatment 2'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nPlacebo: Placebo Comparator: Treatment 3'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3096', 'spread': '0.0162', 'groupId': 'OG000'}, {'value': '0.3077', 'spread': '0.0162', 'groupId': 'OG001'}, {'value': '0.1236', 'spread': '0.0285', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'paramType': 'Test/Reference LS Mean Ratio', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '90', 'paramValue': '1.004', 'ciLowerLimit': '0.889', 'ciUpperLimit': '1.140', 'estimateComment': "Fieller's formula was applied", 'groupDescription': 'Treatments 1 and 2 were baseline adjusted by subtracting Treatment 3 (placebo) from each.', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'To show the clinical equivalence, an ANCOVA model was fit with the endpoint as outcome and treatment, study site and treatment-by site interaction as fixed effects and FEV1 baseline value as covariate.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 1 - Day 49', 'description': 'Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42 (+/- 7 days). Baseline was defined as the average of 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: \\[FEV1 at end of treatment\\] - \\[Baseline FEV1\\].', 'unitOfMeasure': 'liter', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Per Protocol Population'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '613', 'groupId': 'OG000'}, {'value': '622', 'groupId': 'OG001'}, {'value': '204', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment 1', 'description': 'Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nBudesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1'}, {'id': 'OG001', 'title': 'Treatment 2', 'description': 'Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nSymbicort: Active Comparator: Treatment 2'}, {'id': 'OG002', 'title': 'Treatment 3', 'description': 'Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nPlacebo: Placebo Comparator: Treatment 3'}], 'classes': [{'title': 'Upper respiratory tract infection', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}]}, {'title': 'Nasopharyngitis', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}, {'title': 'Viral upper respiratory tract infection', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}]}, {'title': 'Bronchitis', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Asthma', 'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}, {'value': '39', 'groupId': 'OG002'}]}]}, {'title': 'Cough', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Headache', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}, {'title': 'Chest discomfort', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001', 'OG002'], 'groupDescription': 'Comparison of means, no formal statistical comparison', 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'no statistical significance applied'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Weeks', 'description': 'Number of participants reporting at least one adverse event (safety population)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: All enrolled participants who received one dose of a treatment drug. This population was larger than the Per Protocol Population that included only those participants who provided analyzable primary endpoints.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment 1', 'description': 'Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nBudesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1'}, {'id': 'FG001', 'title': 'Treatment 2', 'description': 'Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nSymbicort: Active Comparator: Treatment 2'}, {'id': 'FG002', 'title': 'Treatment 3', 'description': 'Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nPlacebo: Placebo Comparator: Treatment 3'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Safety Population includes all participants who received at least one dose of a treatment.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '613'}, {'groupId': 'FG001', 'numSubjects': '622'}, {'groupId': 'FG002', 'numSubjects': '204'}]}, {'type': 'COMPLETED', 'comment': 'Per Protocol Population includes all participants who provided analyzable data for primary endpoints', 'achievements': [{'groupId': 'FG000', 'numSubjects': '598'}, {'groupId': 'FG001', 'numSubjects': '604'}, {'groupId': 'FG002', 'numSubjects': '199'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '18'}, {'groupId': 'FG002', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': 'Participants (N=1762) were provided a generic placebo pressurized metered dose inhaler (pMDI) device for use during a 2-week Run-in Period for device training. Then, qualified participants (N=1439) were randomly assigned to treatment on a 3:3:1 ratio of generic budesonide/formoterol fumarate dihydrate, Symbicort, or Placebo, respectively.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '613', 'groupId': 'BG000'}, {'value': '622', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}, {'value': '1439', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment 1', 'description': 'Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nBudesonide/Formoterol fumarate dihydrate: Experimental: Treatment 1'}, {'id': 'BG001', 'title': 'Treatment 2', 'description': 'Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nSymbicort: Active Comparator: Treatment 2'}, {'id': 'BG002', 'title': 'Treatment 3', 'description': 'Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period\n\nPlacebo: Placebo Comparator: Treatment 3'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '46.3', 'spread': '15.02', 'groupId': 'BG000'}, {'value': '45.5', 'spread': '14.44', 'groupId': 'BG001'}, {'value': '45.5', 'spread': '14.78', 'groupId': 'BG002'}, {'value': '45.8', 'spread': '14.73', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '375', 'groupId': 'BG000'}, {'value': '392', 'groupId': 'BG001'}, {'value': '137', 'groupId': 'BG002'}, {'value': '904', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '238', 'groupId': 'BG000'}, {'value': '230', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '535', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Randomized participants', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '153', 'groupId': 'BG000'}, {'value': '151', 'groupId': 'BG001'}, {'value': '55', 'groupId': 'BG002'}, {'value': '359', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '460', 'groupId': 'BG000'}, {'value': '471', 'groupId': 'BG001'}, {'value': '149', 'groupId': 'BG002'}, {'value': '1080', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '15', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '107', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}, {'value': '262', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '490', 'groupId': 'BG000'}, {'value': '495', 'groupId': 'BG001'}, {'value': '154', 'groupId': 'BG002'}, {'value': '1139', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '30.73', 'spread': '7.667', 'groupId': 'BG000'}, {'value': '31.27', 'spread': '8.108', 'groupId': 'BG001'}, {'value': '30.93', 'spread': '7.960', 'groupId': 'BG002'}, {'value': '30.99', 'spread': '7.900', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Randomized participants who received at least 1 dose of study drug during Treatment Period'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-10-31', 'size': 706388, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-06-06T14:30', 'hasProtocol': True}, {'date': '2018-03-23', 'size': 767269, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-06-06T14:37', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1762}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'dispFirstSubmitDate': '2018-12-13', 'completionDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-01', 'studyFirstSubmitDate': '2017-01-06', 'dispFirstSubmitQcDate': '2018-12-13', 'resultsFirstSubmitDate': '2022-06-13', 'studyFirstSubmitQcDate': '2017-01-06', 'dispFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-08-01', 'studyFirstPostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area Under the Serial Forced Expiratory Volume in 1 Second (FEV1)', 'timeFrame': 'Day 1', 'description': 'FEV1 Area calculated over 12 hours (measurements at 0, 1, 2, 3, 4, 6, 8, 12 hours post-dose) on Day 1 of treatment. Because this was a primary endpoint, Per Protocol Population used to calculate this endpoint.'}, {'measure': 'Change From Baseline in FEV1 Measured in the Morning at the End of Treatment Visit', 'timeFrame': 'Day 1 - Day 49', 'description': 'Average predose FEV1 at End of Treatment defined as the average of all predose assessments on Day 42 (+/- 7 days). Baseline was defined as the average of 2 predose FEV1 values obtained on Day 1. The endpoint of baseline-adjusted predose FEV1 at end of treatment was calculated as follows: \\[FEV1 at end of treatment\\] - \\[Baseline FEV1\\].'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events', 'timeFrame': '6 Weeks', 'description': 'Number of participants reporting at least one adverse event (safety population)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['bioequivalence'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'A randomized multiple-dose, placebo-controlled, parallel group design consisting of a 2-week run-in period followed by a 6-week treatment period of the placebo, Test product (Budesonide 80 mcg / Formoterol fumarate dihydrate 4.5 mcg), or Reference product Symbicort® inhalation aerosol.', 'detailedDescription': 'This is a pivotal trial that will examine therapeutic equivalence of a new generic fixed-dose combination product containing Budesonide 80 mcg / Formoterol fumarate dihydrate 4.5 mcg and reference listed drug (RLD) Symbicort® inhalation aerosol in adult patients with chronic but stable asthma as defined in National Asthma Education and Prevention Program Expert Panel Report 3 (NAEPP 3) guidelines. To ensure adequate study sensitivity the test and reference products should both be statistically superior to placebo (p\\<0.05) with regard to the bioequivalent study primary endpoints.\n\nA secondary study objective is the safety and tolerability of the test compound.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female subjects of non-childbearing or of childbearing potential committed to consistent and correct use of an acceptable method of birth control\n* Diagnosed with asthma, as defined by the National Asthma Education and Prevention Program (NAEPP),at least 6 months prior to screening\n* Moderate-to-severe asthma with a pre-bronchodilator FEV1 of \\>45% and \\<85% of predicted normal, measured at least 6 hours after short-acting β agonist (SABA)and at least 24 hours after the last dose of long-acting β agonist (LABA), at the screening visit and on the day of treatment\n* \\>15% and \\>0.20 L reversibility of FEV1 within 30 minutes following 360 mcg of albuterol inhalation (pMDI)\n* Patients should be stable on their chronic asthma treatment regimen for at least 4 weeks prior to enrollment\n* Currently non-smoking; having not used tobacco products (i.e., cigarettes, cigars, pipe tobacco) within the past year, and having \\< 10 pack-years of historical use\n* Able to replace current regularly scheduled short-acting β agonists (SABAs) with salbutamol/albuterol inhaler for use only on an as-needed basis for the duration of the study (subjects should be able to withhold all inhaled SABAs for at least 6 hours prior to lung function assessments on study visits)\n* Willing to discontinue their asthma medications (inhaled corticosteroids and long-acting β agonists) during the run-in period and for the remainder of the study\n* Willingness to give their written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Life-threatening asthma, defined as a history of asthma episodes(s) requiring intubation, and/or associated with hypercapnia, respiratory arrest or hypoxic seizures, asthma-related syncopal episodes(s), or hospitalizations within the past year or during the run-in period\n* Significant respiratory disease other than asthma (chronic obstructive pulmonary disease (COPD), interstitial lung disease, etc.)\n* Evidence or history of clinically significant disease or abnormality including congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, or cardiac dysrhythmia. In addition, historical or current evidence of significant hematologic, hepatic, neurologic, psychiatric, renal, or other diseases that, in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbated during the study\n* Patients who required systemic corticosteroids (for any reason) within the past 4 weeks\n* Hypersensitivity to any sympathomimetic drug (e.g., formoterol or albuterol) or any inhaled, intranasal, or systemic corticosteroid therapy\n* Patients currently receiving β-blockers'}, 'identificationModule': {'nctId': 'NCT03015259', 'briefTitle': 'Randomized, Placebo-controlled, Multi-dose, Study Comparing Budesonide/Formoterol to Symbicort® in Asthmatic Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kindeva Drug Delivery'}, 'officialTitle': 'Randomized, Single Blind, Parallel Group, Placebo Controlled, Multidose Study Comparing the Therapeutic Equivalence of a 3M Budesonide/Formoterol Fumarate Inhaler and a Symbicort® Reference Inhaler in Adult Subjects With Asthma', 'orgStudyIdInfo': {'id': 'CSP-07-000034'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment 1', 'description': 'Generic Budesonide/Formoterol Fumarate Dihydrate (80mcg/4.5mcg) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period', 'interventionNames': ['Drug: Budesonide/Formoterol fumarate dihydrate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment 2', 'description': 'Symbicort (Budesonide/Formoterol Fumarate Dihydrate) Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period', 'interventionNames': ['Drug: Symbicort']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment 3', 'description': 'Placebo Inhalation Aerosol, two inhalation twice daily, consisting of a 2-week run-in period followed by a 6-week treatment period', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Budesonide/Formoterol fumarate dihydrate', 'type': 'DRUG', 'otherNames': ['Generic Budesonide/Formoterol fumarate dihydrate'], 'description': 'Experimental: Treatment 1', 'armGroupLabels': ['Treatment 1']}, {'name': 'Symbicort', 'type': 'DRUG', 'otherNames': ['Budesonide/Formoterol fumarate dihydrate'], 'description': 'Active Comparator: Treatment 2', 'armGroupLabels': ['Treatment 2']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo Comparator: Treatment 3', 'armGroupLabels': ['Treatment 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Clinical Research Center of Alabama LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85018', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Elite Clinical Studies', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85253', 'city': 'Tempe', 'state': 'Arizona', 'country': 'United States', 'facility': 'Clinical Research Consortuim Arizona', 'geoPoint': {'lat': 33.41477, 'lon': -111.90931}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Little Rock Allergy and Asthma Clinical Research Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Anaheim Clinical Trials LLC', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '98104', 'city': 'Encinitas', 'state': 'California', 'country': 'United States', 'facility': 'Warren W Pleskow MD', 'geoPoint': {'lat': 33.03699, 'lon': -117.29198}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma Specialists Medical Group', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'California Allergy and Asthma Medical Group Inc', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonathan Corren MD, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Southern California Institute For Respiratory Diseases, Inc.', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92691', 'city': 'Mission Viejo', 'state': 'California', 'country': 'United States', 'facility': 'Allergy and Asthma Associates of Southern California, A Medical Group, Inc.', 'geoPoint': {'lat': 33.60002, 'lon': -117.672}}, {'zip': '92506', 'city': 'Riverside', 'state': 'California', 'country': 'United States', 'facility': 'Integrated Research Group Inc', 'geoPoint': {'lat': 33.95335, 'lon': -117.39616}}, {'zip': 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