Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2026-01-01 @ 8:51 PM
Study NCT ID:
NCT03256695
Status:
COMPLETED
Last Update Posted:
2021-11-09
First Post:
2017-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000420', 'term': 'Albuterol'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'USMedInfo@tevapharm.com', 'phone': '1-888-483-8279', 'title': 'Director, Clinical Research', 'organization': 'Teva Branded Pharmaceutical Products, R&D Inc.'}, 'certainAgreement': {'otherDetails': "Sponsor has the right 60 days before submission for publication to review/provide comments. If the Sponsor's review shows that potentially patentable subject matter would be disclosed, publication or public disclosure shall be delayed for up to 90 additional days in order for the Sponsor, or Sponsor's designees, to file the necessary patent applications. In multicenter trials, each PI will postpone single center publications until after disclosure or publication of multicenter data.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'AEs were collected from signature of the informed consent form (ICF) to Week 12.', 'description': 'AEs were reported from Baseline (Day 1) up to Week 12. ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.', 'eventGroups': [{'id': 'EG000', 'title': 'ABS eMDPI', 'description': 'Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.', 'otherNumAtRisk': 405, 'deathsNumAtRisk': 405, 'otherNumAffected': 94, 'seriousNumAtRisk': 405, 'deathsNumAffected': 2, 'seriousNumAffected': 44}], 'otherEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 104, 'numAffected': 94}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}], 'seriousEvents': [{'term': 'Acute left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Acute myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Cardiac failure congestive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Left ventricular failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Osteomyelitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Pneumonia staphylococcal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Pneumonia viral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Rhinovirus infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Burns first degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Influenza A virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Influenza B virus test positive', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Arthralgia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Substance use disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 6, 'numAffected': 5}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 24, 'numAffected': 22}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}, {'term': 'Dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 405, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA v20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Clinical Exacerbation of COPD (CE-COPD) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CE-COPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '396', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABS eMDPI', 'description': 'Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'CE-COPD was an occurrence of either severe CE-COPD or moderate CE-COPD. Severe CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with systemic corticosteroids (SCS; at least 10 milligrams \\[mg\\] prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization for CE COPD.\n\nModerate CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit) for a CE-COPD, but not a hospitalization.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all enrolled participants regardless of whether a participant took any IMP. Participants with CE-COPD during study Day 1 through study Day 7 were excluded from the analysis.'}, {'type': 'PRIMARY', 'title': 'Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABS eMDPI', 'description': 'Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.'}], 'classes': [{'title': 'Day 1 prior to CE-COPD symptom peak', 'categories': [{'measurements': [{'value': '3.7', 'spread': '4.36', 'groupId': 'OG000'}]}]}, {'title': 'Day 3 prior to CE-COPD symptom peak', 'categories': [{'measurements': [{'value': '3.5', 'spread': '4.61', 'groupId': 'OG000'}]}]}, {'title': 'Day 5 prior to CE-COPD symptom peak', 'categories': [{'measurements': [{'value': '4.2', 'spread': '5.35', 'groupId': 'OG000'}]}]}, {'title': 'Day 7 prior to CE-COPD symptom peak', 'categories': [{'measurements': [{'value': '3.4', 'spread': '4.45', 'groupId': 'OG000'}]}]}, {'title': 'Day 10 prior to CE-COPD symptom peak', 'categories': [{'measurements': [{'value': '3.2', 'spread': '4.41', 'groupId': 'OG000'}]}]}, {'title': 'Day 14 prior to CE-COPD symptom peak', 'categories': [{'measurements': [{'value': '3.4', 'spread': '4.42', 'groupId': 'OG000'}]}]}, {'title': 'Day 21 prior to CE-COPD symptom peak', 'categories': [{'measurements': [{'value': '3.1', 'spread': '4.54', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'Severe CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization. Moderate CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, office visit, urgent care visit, or emergency care visit), but not a hospitalization. Total number of inhalations taken in 1 day(24-hour period on day prior to date of CE-COPD symptom peak) and at 3,5,7,10,14, and 21 days preceding the date of CE-COPD symptom peak were reported. If a participant experienced multiple CE-COPD events, number of inhalations preceding symptom peak of a subsequent event was counted since end of previous event. Average of inhalations of all events were presented.', 'unitOfMeasure': 'inhalations', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set:all enrolled participants regardless of whether a participant took any IMP. Participants with CE-COPD during Day 1 to Day 7 were excluded. 'Overall number of participants analyzed'= participants experiencing at least 1 moderate or severe CE-COPD."}, {'type': 'PRIMARY', 'title': 'Number of Days Prior to the Symptom Peak of a CE-COPD Event When Albuterol Use Increased', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABS eMDPI', 'description': 'Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.'}], 'classes': [{'title': 'Days from albuterol use >20% increase to CE-COPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '96', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '32.7', 'spread': '19.92', 'groupId': 'OG000'}]}]}, {'title': 'Days from 2 inhalations increase to CE-COPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '31.2', 'spread': '21.30', 'groupId': 'OG000'}]}]}, {'title': 'Days from 4 inhalations increase to CE-COPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '50', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '30.4', 'spread': '21.24', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'CE-COPD: occurrence of moderate or severe CE-COPD. Severe CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization. Moderate CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit), but not a hospitalization. Number of days of increased albuterol use prior to the symptom peak of a CE-COPD was reported for first increase of daily albuterol use; 2 and 4 inhalations in a single day from baseline. increased daily albuterol use was defined as single-day increase of greater than (\\>) 20 percent (%) from baseline.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set: all enrolled participants regardless of whether a participant took any IMP. 'Overall number of participants analyzed'= participants experiencing at least 1 moderate or severe CE-COPD. 'Number analyzed'=participants evaluable for specified categories. Participants with CE-COPD during Day 1 to Day 7 were excluded."}, {'type': 'PRIMARY', 'title': 'Number of Albuterol Uses in the 24 Hours Preceding a CE-COPD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '109', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABS eMDPI', 'description': 'Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '4.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 12', 'description': 'CE-COPD referred to occurrence of moderate or severe CE-COPD. Severe CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization for CE COPD. Moderate CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit) for a CE-COPD, but not a hospitalization. Number of albuterol inhalations used in the 24 hours preceding a moderate or severe CE-COPD was reported.', 'unitOfMeasure': 'inhalations/24 hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "ITT analysis set: all enrolled participants regardless of whether a participant took any IMP. Participants with CE-COPD during Day 1 to Day 7 were excluded. 'Overall number of participants analyzed' = participants who experienced at least 1 moderate or severe CE-COPD and reported albuterol use in the 24 hours preceding a moderate or severe CE-COPD."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ABS eMDPI', 'description': 'Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '190', 'groupId': 'OG000'}]}]}, {'title': 'Severe AEs', 'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-related AEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Treatment-related severe AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Serious AEs', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}]}]}, {'title': 'AEs leading to discontinuation from study', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'CE-COPD related AEs', 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}]}]}, {'title': 'Device-related AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'AEs leading to death', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 12', 'description': "AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by investigator. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT analysis set included all enrolled participants regardless of whether a participant took any IMP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'ABS eMDPI', 'description': 'Participants received 90 micrograms (mcg) of albuterol sulfate (ABS) via a multidose dry powder inhaler (MDPI) with an eModule (eMDPI) (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '405'}]}, {'type': 'Used ABS eMDPI at Least Once', 'achievements': [{'groupId': 'FG000', 'numSubjects': '390'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '366'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'Non-compliance with study drug', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}]}], 'preAssignmentDetails': 'A total of 423 participants with exacerbation-prone chronic obstructive pulmonary disease (COPD) were screened, of which 405 participants at 40 investigational centers in the United States met entry criteria and were considered to be eligible for enrollment into the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '405', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'ABS eMDPI', 'description': 'Participants received 90 mcg of ABS via eMDPI (that had a sensor on the top of device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI was a rescue/reliever agent that included an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants were allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.6', 'spread': '8.70', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '220', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '185', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '371', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '38', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '365', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Number of COPD Exacerbations in the Past 12 Months', 'classes': [{'categories': [{'measurements': [{'value': '1.5', 'spread': '0.98', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'exacerbations', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The intent-to-treat (ITT) analysis set included all enrolled participants regardless of whether a participant took any investigational medicinal product (IMP).'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-06-26', 'size': 1259913, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-04T14:01', 'hasProtocol': True}, {'date': '2018-04-27', 'size': 786954, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-04T14:01', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 405}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-05', 'studyFirstSubmitDate': '2017-08-18', 'resultsFirstSubmitDate': '2019-06-04', 'studyFirstSubmitQcDate': '2017-08-18', 'lastUpdatePostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-07-12', 'studyFirstPostDateStruct': {'date': '2017-08-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Clinical Exacerbation of COPD (CE-COPD) Rate: Percentage of Participants Who Experienced at Least 1 Moderate or Severe CE-COPD', 'timeFrame': 'Baseline (Day 1) to Week 12', 'description': 'CE-COPD was an occurrence of either severe CE-COPD or moderate CE-COPD. Severe CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with systemic corticosteroids (SCS; at least 10 milligrams \\[mg\\] prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization for CE COPD.\n\nModerate CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit) for a CE-COPD, but not a hospitalization.'}, {'measure': 'Total Number of Albuterol Inhalations in the Days Preceding the Symptom Peak of a CE-COPD Event', 'timeFrame': 'Baseline to Week 12', 'description': 'Severe CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization. Moderate CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, office visit, urgent care visit, or emergency care visit), but not a hospitalization. Total number of inhalations taken in 1 day(24-hour period on day prior to date of CE-COPD symptom peak) and at 3,5,7,10,14, and 21 days preceding the date of CE-COPD symptom peak were reported. If a participant experienced multiple CE-COPD events, number of inhalations preceding symptom peak of a subsequent event was counted since end of previous event. Average of inhalations of all events were presented.'}, {'measure': 'Number of Days Prior to the Symptom Peak of a CE-COPD Event When Albuterol Use Increased', 'timeFrame': 'Baseline to Week 12', 'description': 'CE-COPD: occurrence of moderate or severe CE-COPD. Severe CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization. Moderate CE-COPD: an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit), but not a hospitalization. Number of days of increased albuterol use prior to the symptom peak of a CE-COPD was reported for first increase of daily albuterol use; 2 and 4 inhalations in a single day from baseline. increased daily albuterol use was defined as single-day increase of greater than (\\>) 20 percent (%) from baseline.'}, {'measure': 'Number of Albuterol Uses in the 24 Hours Preceding a CE-COPD', 'timeFrame': 'Baseline to Week 12', 'description': 'CE-COPD referred to occurrence of moderate or severe CE-COPD. Severe CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline) and/or systemic antibiotics and a hospitalization for CE COPD. Moderate CE-COPD was defined as an event that involved worsening respiratory symptoms for at least 2 consecutive days requiring treatment with SCS (at least 10 mg prednisone equivalent above baseline), and/or systemic antibiotics, and an unscheduled encounter (such as a phone call, an office visit, an urgent care visit, or an emergency care visit) for a CE-COPD, but not a hospitalization. Number of albuterol inhalations used in the 24 hours preceding a moderate or severe CE-COPD was reported.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline up to Week 12', 'description': "AE was defined as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by investigator on a scale of mild, moderate and severe, with severe= an inability to carry out usual activities. Relation of AE to treatment was determined by investigator. SAEs included death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized the participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of serious and non-serious AEs regardless of causality is located in 'Reported Adverse Events module'."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '40355297', 'type': 'DERIVED', 'citation': 'Snyder LD, DePietro M, Reich M, Neely ML, Lugogo N, Pleasants R, Li T, Granovsky L, Brown R, Safioti G. Predictive machine learning algorithm for COPD exacerbations using a digital inhaler with integrated sensors. BMJ Open Respir Res. 2025 May 12;12(1):e002577. doi: 10.1136/bmjresp-2024-002577.'}]}, 'descriptionModule': {'briefSummary': 'This is a Phase 3B, 12-week, multicenter, open-label study to evaluate the relationship between as-needed usage of albuterol eMDPI and Clinical Exacerbation-Chronic Obstructive Pulmonary Disease (CE-COPD) in adult participants at least 40 years of age with exacerbation-prone COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant has had at least 1 episode of moderate or severe CE-COPD over the past 12 months before screening.\n* The participant must be able to demonstrate appropriate use of albuterol from the ABS eMDPI.\n* The participant is currently using a short-acting beta agonist (SABA) reliever plus at least one of the following: long-acting beta agonist (LABA), an inhaled corticosteroid (ICS)/LABA, a long-acting muscarinic antagonist (LAMA), or a LABA/LAMA.\n* The participant must be willing and able to comply with study requirements as specified in the protocol, including the use of a wearable accelerometer for the subset of participants who consent to use of the device.\n* The participant is willing to discontinue all other rescue or maintenance SABA or antimuscarinic agents and replace them with the study-provided ABS eMDPI for the duration of the trial.\n* Women of childbearing potential (not surgically sterile or greater than or equal to \\[≥\\]2 years postmenopausal) must have exclusively same-sex partners or use a highly effective method of birth control and must agree to continue the use of this method for the duration of the study and for 30 days after discontinuation of the investigational medicinal product (IMP).\n\n * Additional criteria apply, please contact the investigator for more information.\n\nExclusion Criteria:\n\n* The participant has any clinically significant medical condition (treated or untreated) that, in the opinion of the investigator, would interfere with participation in the study.\n* The participant has any other confounding underlying lung disorder other than COPD.\n* The participant has used an investigational drug within 5 half-lives of it being discontinued or within1 month of Visit 2 (Baseline \\[Day 1\\]), whichever is longer.\n* The participant is a pregnant or lactating woman, or plans to become pregnant during the study. Note: Any woman becoming pregnant during the study will be withdrawn from the study.\n* The participant is known to be allergic to albuterol or any of the excipients in the IMP or rescue medication formulation (that is, lactose \\[milk protein\\]). Dietary lactose intolerance does not exclude the participant from inclusion in the study or as per the investigator\'s medical discretion.\n* The participant has a history or presence of "silent" infections, including positive testing for human immunodeficiency virus types 1 and 2, hepatitis B, hepatitis C, and tuberculosis.\n\n * Additional criteria apply, please contact the investigator for more information.'}, 'identificationModule': {'nctId': 'NCT03256695', 'briefTitle': 'Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A 12-Week, Open-Label Study to Evaluate the Relationship Between Use of Albuterol eMDPI, an Inhaled Short-Acting Beta Agonist "Rescue" Agent With an eModule, and Exacerbations in Patients (40 Years of Age or Older) With Chronic Obstructive Pulmonary Disease', 'orgStudyIdInfo': {'id': 'ABS-COPD-30065'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ABS eMDPI', 'description': 'Participants will receive 90 micrograms (mcg) of albuterol sulfate (ABS) via eMDPI (sitting on the upper part of the device for the purposes of detecting and storing usage information), 1 to 2 inhalations every 4 hours, as needed for 12 weeks. ABS eMDPI is a rescue/reliever agent that includes an eModule on top of the approved PROAIR RESPICLICK® inhaler. Participants will be allowed to continue use of other COPD and non-COPD medications as advised by their physician without changes unless deemed necessary by their physician.', 'interventionNames': ['Drug: Albuterol sulfate (ABS)']}], 'interventions': [{'name': 'Albuterol sulfate (ABS)', 'type': 'DRUG', 'description': 'ABS will be administered via eMDPI as per the dose and schedule specified in the arm.', 'armGroupLabels': ['ABS eMDPI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '36420', 'city': 'Andalusia', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 14682', 'geoPoint': {'lat': 31.30808, 'lon': -86.48243}}, {'zip': '36207', 'city': 'Anniston', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 14704', 'geoPoint': {'lat': 33.65983, 'lon': -85.83163}}, {'zip': '36608', 'city': 'Mobile', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 14712', 'geoPoint': {'lat': 30.69436, 'lon': -88.04305}}, {'zip': '85381', 'city': 'Peoria', 'state': 'Arizona', 'country': 'United States', 'facility': 'Teva Investigational Site 14702', 'geoPoint': {'lat': 33.5806, 'lon': -112.23738}}, {'zip': '95670', 'city': 'Gold River', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 14706', 'geoPoint': {'lat': 38.62629, 'lon': -121.24662}}, {'zip': '06708', 'city': 'Waterbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Teva Investigational Site 14720', 'geoPoint': {'lat': 41.55815, 'lon': -73.0515}}, {'zip': '33511', 'city': 'Brandon', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14725', 'geoPoint': {'lat': 27.9378, 'lon': -82.28592}}, {'zip': '32117', 'city': 'Daytona Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14711', 'geoPoint': {'lat': 29.21081, 'lon': -81.02283}}, {'zip': '32720', 'city': 'DeLand', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14699', 'geoPoint': {'lat': 29.02832, 'lon': -81.30312}}, {'zip': '32132', 'city': 'Edgewater', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14694', 'geoPoint': {'lat': 28.98888, 'lon': -80.90228}}, {'zip': '33126', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14701', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33135', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14689', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33155', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14678', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '32825', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14688', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '46383', 'city': 'Valparaiso', 'state': 'Indiana', 'country': 'United States', 'facility': 'Teva Investigational Site 14679', 'geoPoint': {'lat': 41.47309, 'lon': -87.06114}}, {'zip': '02747', 'city': 'North Dartmouth', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Teva Investigational Site 14677', 'geoPoint': {'lat': 41.63899, 'lon': -70.97032}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 14705', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '68114', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Teva Investigational Site 14717', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08755', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Teva Investigational Site 14684', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14710', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28054', 'city': 'Gastonia', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14696', 'geoPoint': {'lat': 35.26208, 'lon': -81.1873}}, {'zip': '27408', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14722', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14692', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 14708', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '45458', 'city': 'Dayton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 14703', 'geoPoint': {'lat': 39.75895, 'lon': -84.19161}}, {'zip': '43123', 'city': 'Grove City', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 14680', 'geoPoint': {'lat': 39.88145, 'lon': -83.09296}}, {'zip': '43617', 'city': 'Toledo', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 14709', 'geoPoint': {'lat': 41.66394, 'lon': -83.55521}}, {'zip': '44094', 'city': 'Willoughby', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 14724', 'geoPoint': {'lat': 41.63977, 'lon': -81.4065}}, {'zip': '15243', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 14683', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '29406', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14681', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29640', 'city': 'Easley', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14686', 'geoPoint': {'lat': 34.82984, 'lon': -82.60152}}, {'zip': '29341', 'city': 'Gaffney', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14719', 'geoPoint': {'lat': 35.07179, 'lon': -81.64982}}, {'zip': '29615', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14691', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '29464', 'city': 'Mt. Pleasant', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14695', 'geoPoint': {'lat': 32.79407, 'lon': -79.86259}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14715', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14718', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '29379', 'city': 'Union', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14707', 'geoPoint': {'lat': 34.71541, 'lon': -81.62371}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 14716', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Teva Investigational Site 14713', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 14687', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Teva Medical Expert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}