Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2026-03-20 @ 6:57 PM
Study NCT ID:
NCT03890666
Status:
COMPLETED
Last Update Posted:
2022-12-07
First Post:
2019-03-18
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': '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': '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': 'Baseline up to Week 14', 'description': 'Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.', 'eventGroups': [{'id': 'EG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.', 'otherNumAtRisk': 166, 'deathsNumAtRisk': 166, 'otherNumAffected': 8, 'seriousNumAtRisk': 166, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.', 'otherNumAtRisk': 150, 'deathsNumAtRisk': 150, 'otherNumAffected': 11, 'seriousNumAtRisk': 150, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 12, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'SARS-CoV-2 sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Ovarian cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 166, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 150, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.6', 'groupId': 'OG000'}, {'value': '61.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'paramValue': '1.33', 'groupDescription': 'The statistical model is a logistic regression model with treatment group as a fixed factor, pooled study sites as a random factor, and baseline ACT score as a covariate.', 'nonInferiorityType': 'OTHER'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Week 12', 'description': 'Meaningful asthma improvement was defined as an Asthma Control Test (ACT) score of at least 20 at the end of the 12-week treatment period or an increase of at least 3 units on the ACT score from baseline at the end of the 12-week treatment period. The ACT was a simple, participant-completed tool used to assess overall asthma control. The 5 items included in the ACT assess daytime and night-time asthma symptoms, use of reliever medication, and impact of asthma on daily functioning. Each item in the ACT was scored on a 5-point scale, with a summation of all items providing scores ranging from 5 to 25. The scores span the continuum of poor control of asthma (score of 5) to complete control of asthma (score of 25), with a cutoff score of 19 and below indicating participants with poorly controlled asthma.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints.'}, {'type': 'SECONDARY', 'title': 'Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'title': 'No discussion', 'measurements': [{'value': '121', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}, {'title': '1 discussion', 'measurements': [{'value': '38', 'groupId': 'OG000'}, {'value': '39', 'groupId': 'OG001'}]}, {'title': '2 discussions', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}, {'title': '3 discussions', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': '4 discussions', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': '5 discussions', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Decreased Doses of Inhaled Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '163', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'title': 'No decreased doses', 'measurements': [{'value': '163', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}]}, {'title': '1 decreased dose', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who received decreased dose of inhaled medication during the 12-week treatment period are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints.'}, {'type': 'SECONDARY', 'title': 'Number of Increased Doses of Inhaled Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'title': 'No increased doses', 'measurements': [{'value': '157', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}, {'title': '1 increased dose', 'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '2 increased doses', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Changes to Different Inhaled Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'title': 'No change to different inhaled medication', 'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '143', 'groupId': 'OG001'}]}, {'title': '1 change to different inhaled medication', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': '2 changes to different inhaled medication', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who received different inhaled medication during the 12-week treatment period are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Additional Inhaled Medication', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'title': 'No additional inhaled medication', 'measurements': [{'value': '161', 'groupId': 'OG000'}, {'value': '145', 'groupId': 'OG001'}]}, {'title': '1 additional inhaled medication', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who received additional inhaled medication during the 12-week treatment period are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'title': 'No addition of a systemic corticosteroid medication for asthma therapy', 'measurements': [{'value': '159', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}, {'title': '1 addition of a systemic corticosteroid medication for asthma therapy', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}, {'title': '2 addition of a systemic corticosteroid medication for asthma therapy', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 12-week treatment period are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '147', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'title': 'No intervention to manage comorbid conditions', 'measurements': [{'value': '158', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}]}, {'title': 'Interventions taken 1 time to manage comorbid conditions', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Interventions taken 2 times to manage comorbid conditions', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-36.18', 'spread': '125.519', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'mcg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group', 'denoms': [{'units': 'Participants', 'counts': [{'value': '148', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.4', 'spread': '2.36', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'System Usability Scale (SUS) Overall Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '139', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '79.8', 'spread': '15.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 12', 'description': 'The SUS was used to explore device acceptability and usability for participants in the DS group. It covered a variety of aspects of system usability, such as the need for support, training, and complexity, and thus giving a global view of subjective assessments of usability. It was a 10-question tool (with five response options; from 1=strongly disagree to 5=strongly agree) that provided a composite measure, ranging from 0 to 100, of the overall usability of the system being studied. Higher scores represent better usability level for the tool.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.35', 'spread': '3.767', 'groupId': 'OG000'}, {'value': '-0.72', 'spread': '4.485', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ concern is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicated their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BMQ Necessity Subscale Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.2', 'spread': '3.69', 'groupId': 'OG000'}, {'value': '-0.9', 'spread': '3.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': "The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ necessity is a 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicated degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs).", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.1', 'spread': '2.30', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '1.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'The BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. Only one item assesses illness comprehensibility or coherence of illness (Item 7: How well do you feel you understand your illness?). This item was rated using a 0 (do not understand at all) to 10 (understand very clearly) response scale. A higher score indicates a stronger illness comprehensibility.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BIPQ Cognitive Subscale Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.6', 'spread': '5.32', 'groupId': 'OG000'}, {'value': '-2.0', 'spread': '5.13', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 5 items on cognitive representation of illness perception: consequences (Item 1: How much does your illness affect your life? Response range 0 \\[no affect\\] - 10 \\[severe affect\\]), timeline (Item 2: How long do you think your illness will continue? Response range 0 \\[a very short time\\] - 10 \\[forever\\]), personal control (Item 3: How much control do you feel you have over your illness? Response range 0 \\[no control\\] - 10 \\[extreme amount of control\\]), treatment control (Item 4: How much do you think your treatment can help your illness? Response range 0 \\[not at all\\] - 10 \\[extremely helpful\\]), and identity (Item 5: How much do you experience symptoms from your illness? Response range 0 \\[no symptoms\\] - 10 \\[severe symptoms\\]). Total BIPQ Cognitive Subscale Score was the sum of all item score and ranged from 0 to 50. A higher score indicates stronger illness perception.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '153', 'groupId': 'OG000'}, {'value': '135', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.1', 'spread': '3.76', 'groupId': 'OG000'}, {'value': '-0.8', 'spread': '4.11', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 2 items on emotional representation: concern (Item 6: How concerned are you about your illness? Response range 0 \\[not at all concerned\\] - 10 \\[extremely concerned\\]) and emotions (Item 8: How much does your illness affect you emotionally; for example, does it make you angry, scared, upset or depressed? Response range 0 \\[not at all affected emotionally\\] - 10 \\[extremely affected emotionally\\]). Total BIPQ Emotional Subscale Score was the sum of above 2 items score and ranged from 0 to 20. A higher score indicates extreme emotional representation.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "mITT analysis set included all randomized participants who received at least 1 dose of IMP (IMP is albuterol eMDPI for the DS group and standard-of-care albuterol-administering rescue medication for the CC group) and at least 1 postbaseline assessment on any of the study endpoints. Here, 'overall number of participants analyzed' = participants evaluable for this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'OG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'classes': [{'title': 'Any AEs', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related AE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Device-related AEs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline up to Week 14', 'description': "An 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. 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'. Number of participants with any AEs, treatment-related AEs, and device-related AEs has been reported.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants in the DS group who received at least 1 dose of IMP and all participants in the CC group.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'FG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol multidose dry powder inhaler with integrated electronic module (eMDPI) DS (including instructions on how to use both the eMDPI and the Smart Device Application \\[App\\]) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test investigational medicinal product \\[IMP\\]); Device 2: Patient-facing App; Device 3: Digital health platform (DHP) (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 micrograms (mcg) albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Intent-to-treat (ITT) analysis set: included all randomized participants', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '167'}]}, {'type': 'Safety Analysis Set', 'comment': 'All participants in the DS group who receive at least 1 dose of IMP and all participants in the CC group.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '166'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'Modified Intent-to-treat (mITT) Analysis Set', 'comment': 'Al participants who received at least 1 dose of IMP and at least 1 postbaseline assessment on any of the study endpoints.', 'achievements': [{'groupId': 'FG000', 'numSubjects': '163'}, {'groupId': 'FG001', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '149'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '18'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Protocol deviation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}, {'type': 'Other than specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '8'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '166', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '333', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Concurrent Control (CC)', 'description': 'Participants were treated with their standard of care albuterol-administering reliever inhalers and did not use the digital system during the treatment period. Participants were reimbursed or given a voucher to use to purchase their existing reliever medications.'}, {'id': 'BG001', 'title': 'Digital System (DS)', 'description': 'Participants were trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, received 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI DS consisted of 4 devices: Device 1: albuterol eMDPI (the test IMP); Device 2: Patient-facing App; Device 3: DHP (Cloud solution); and Device 4: Provider-facing Dashboard. Participants received 90 mcg albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '43.6', 'spread': '16.61', 'groupId': 'BG000'}, {'value': '43.9', 'spread': '16.63', 'groupId': 'BG001'}, {'value': '43.7', 'spread': '16.60', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '110', 'groupId': 'BG000'}, {'value': '120', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '103', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '40', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '121', 'groupId': 'BG000'}, {'value': '126', 'groupId': 'BG001'}, {'value': '247', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '124', 'groupId': 'BG000'}, {'value': '116', 'groupId': 'BG001'}, {'value': '240', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'ITT analysis set included all randomized participants.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-03-12', 'size': 1529073, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-09-29T11:28', 'hasProtocol': True}, {'date': '2021-10-13', 'size': 831911, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-09-29T11:28', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 333}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-05', 'studyFirstSubmitDate': '2019-03-18', 'resultsFirstSubmitDate': '2022-09-29', 'studyFirstSubmitQcDate': '2019-03-25', 'lastUpdatePostDateStruct': {'date': '2022-12-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2022-09-29', 'studyFirstPostDateStruct': {'date': '2019-03-26', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2022-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Meaningful Asthma Improvement at the End of 12-Week Treatment Period', 'timeFrame': 'Baseline to Week 12', 'description': 'Meaningful asthma improvement was defined as an Asthma Control Test (ACT) score of at least 20 at the end of the 12-week treatment period or an increase of at least 3 units on the ACT score from baseline at the end of the 12-week treatment period. The ACT was a simple, participant-completed tool used to assess overall asthma control. The 5 items included in the ACT assess daytime and night-time asthma symptoms, use of reliever medication, and impact of asthma on daily functioning. Each item in the ACT was scored on a 5-point scale, with a summation of all items providing scores ranging from 5 to 25. The scores span the continuum of poor control of asthma (score of 5) to complete control of asthma (score of 25), with a cutoff score of 19 and below indicating participants with poorly controlled asthma.'}], 'secondaryOutcomes': [{'measure': 'Number of Discussions Between Participant and Investigational Center Healthcare Professional (iHCP) Regarding Inhaler Technique or Adherence', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who had discussions with iHCP regarding inhaler technique or adherence are reported.'}, {'measure': 'Number of Decreased Doses of Inhaled Medication', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who received decreased dose of inhaled medication during the 12-week treatment period are reported.'}, {'measure': 'Number of Increased Doses of Inhaled Medication', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who received increased dose of inhaled medication during the 12-week treatment period are reported.'}, {'measure': 'Number of Changes to Different Inhaled Medication', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who received different inhaled medication during the 12-week treatment period are reported.'}, {'measure': 'Number of Additional Inhaled Medication', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who received additional inhaled medication during the 12-week treatment period are reported.'}, {'measure': 'Number of Addition of a Systemic Corticosteroid Medication for Asthma Therapy', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants who received additional systemic corticosteroid medication for asthma therapy during the 12-week treatment period are reported.'}, {'measure': 'Frequency of Intervention to Manage Comorbid Conditions Associated With Poor Asthma Control', 'timeFrame': 'Baseline up to Week 12', 'description': 'Number of participants with different frequency of intervention to manage comorbid conditions such as Gastroesophageal Reflux Disease (GERD) and Sinusitis are reported.'}, {'measure': 'Change From Baseline in Mean Weekly Short-acting Beta2 Agonist (SABA) Usage at Week 12 for the DS Group', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'Change From Baseline in the Number of SABA-free Days at Week 12 for the DS Group', 'timeFrame': 'Baseline, Week 12'}, {'measure': 'System Usability Scale (SUS) Overall Score', 'timeFrame': 'Week 12', 'description': 'The SUS was used to explore device acceptability and usability for participants in the DS group. It covered a variety of aspects of system usability, such as the need for support, training, and complexity, and thus giving a global view of subjective assessments of usability. It was a 10-question tool (with five response options; from 1=strongly disagree to 5=strongly agree) that provided a composite measure, ranging from 0 to 100, of the overall usability of the system being studied. Higher scores represent better usability level for the tool.'}, {'measure': 'Change From Baseline in Beliefs About Medicines Questionnaire (BMQ) Concern Subscale Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ concern is a 6-item scale assessing participant's concerns about potential adverse consequences (range: 1=strongly disagree to 5=strongly agree). Participants indicated their degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs)."}, {'measure': 'Change From Baseline in BMQ Necessity Subscale Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': "The BMQ was used to assess cognitive representations of medicine. The Beliefs About Medicines Questionnaire-Specific 11 (BMQ-S11) was an 11-item questionnaire that assessed the representation of medication prescribed for personal use and the BMQ-General assesses beliefs about medicines in general. BMQ necessity is a 5-item scale assessing participant's beliefs about necessity of medications for controlling disease. Participants indicated degree of agreement on a 5-point scale, ranging from 1=strongly disagree to 5=strongly agree. Scores obtained for individual items were summed, divided by the total number of items and multiplied by 5 to give a total score ranging from 5 to 25 (higher scores=stronger beliefs)."}, {'measure': 'Change From Baseline in Brief Illness Perception Questionnaire (BIPQ) Illness Comprehensibility Subscale Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'The BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. Only one item assesses illness comprehensibility or coherence of illness (Item 7: How well do you feel you understand your illness?). This item was rated using a 0 (do not understand at all) to 10 (understand very clearly) response scale. A higher score indicates a stronger illness comprehensibility.'}, {'measure': 'Change From Baseline in BIPQ Cognitive Subscale Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 5 items on cognitive representation of illness perception: consequences (Item 1: How much does your illness affect your life? Response range 0 \\[no affect\\] - 10 \\[severe affect\\]), timeline (Item 2: How long do you think your illness will continue? Response range 0 \\[a very short time\\] - 10 \\[forever\\]), personal control (Item 3: How much control do you feel you have over your illness? Response range 0 \\[no control\\] - 10 \\[extreme amount of control\\]), treatment control (Item 4: How much do you think your treatment can help your illness? Response range 0 \\[not at all\\] - 10 \\[extremely helpful\\]), and identity (Item 5: How much do you experience symptoms from your illness? Response range 0 \\[no symptoms\\] - 10 \\[severe symptoms\\]). Total BIPQ Cognitive Subscale Score was the sum of all item score and ranged from 0 to 50. A higher score indicates stronger illness perception.'}, {'measure': 'Change From Baseline in BIPQ Emotional Representations Subscale Score at Week 12', 'timeFrame': 'Baseline, Week 12', 'description': 'BIPQ was a 9-item questionnaire designed to rapidly assess cognitive and emotional representations of illness. It comprised 2 items on emotional representation: concern (Item 6: How concerned are you about your illness? Response range 0 \\[not at all concerned\\] - 10 \\[extremely concerned\\]) and emotions (Item 8: How much does your illness affect you emotionally; for example, does it make you angry, scared, upset or depressed? Response range 0 \\[not at all affected emotionally\\] - 10 \\[extremely affected emotionally\\]). Total BIPQ Emotional Subscale Score was the sum of above 2 items score and ranged from 0 to 20. A higher score indicates extreme emotional representation.'}, {'measure': 'Number of Participants With Adverse Events (AEs)', 'timeFrame': 'Baseline up to Week 14', 'description': "An 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. 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'. Number of participants with any AEs, treatment-related AEs, and device-related AEs has been reported."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This is a 12-week treatment, multicenter, open-label, randomized, parallel group comparison feasibility study to evaluate the effectiveness of the Albuterol eMDPI Digital System (DS), including inhaler, App, digital health platform (DHP) (Cloud solution), and dashboard, to optimize outcomes in participants at least 13 years of age or older with asthma.\n\nThe study will consist of a screening visit, a 12-week open-label treatment period, and a follow-up telephone call (2 weeks following treatment completion).\n\nParticipants with suboptimal asthma control will be enrolled in the study and randomized in a 1:1 ratio to 1 of 2 parallel groups stratified by investigational center: DS group participants utilizing the Albuterol eMDPI DS, including inhaler, App, DHP (Cloud solution), and dashboard, and CC group participants who will be treated with their standard of care albuterol-administering rescue inhalers and will not use the DS during the treatment period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant has a documented diagnosis of asthma\n* The participant is currently on treatment with an inhaled corticosteroid (ICS) with a long-acting beta2 antagonist (LABA).\n* The participant is currently using inhaled albuterol sulfate as rescue medication and is willing to discontinue all other rescue medications and replace them with the study provided Albuterol eMDPI.\n* The participant can read and communicate in English and is familiar with and is willing to use his/her own smart device and download and use the App.\n\n * Additional criteria apply, please contact the investigator for more information\n\nExclusion Criteria:\n\n* The participant has any clinically significant uncontrolled medical condition (treated or untreated) other than asthma.\n* The participant was hospitalized for severe asthma in the last 30 days.\n* The participant has a diagnosis of Chronic Obstructive Pulmonary Disease (COPD) or Asthma-COPD Overlap (ACO).\n* The participant is a current smoker or has a greater than 10 pack-year history of smoking.\n* The participant is currently being treated with systemic corticosteroids (oral, intramuscular, or intravenous) or has been treated within the last 30 days.\n* The participant has any treatment with biologics for asthma (for example, omalizumab, anti-IL5, anti-IL5R, anti-IL4R), or has had such treatment within the last 90 days.\n\n * Additional criteria apply, please contact the investigator for more information'}, 'identificationModule': {'nctId': 'NCT03890666', 'acronym': 'CONNECT1', 'briefTitle': 'A 12-Week Treatment Study to Evaluate the Effectiveness of Albuterol Multidose Dry Powder Inhaler With Integrated Electronic Module Digital System (eMDPI DS) in Participants13 Years or Older With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'CONNected Electronic Inhalers Asthma Control Trial 1 ("CONNECT 1"), a 12-Week Treatment, Multicenter, Open-Label, Randomized, Parallel Group Comparison, Feasibility Study to Evaluate the Effectiveness of the Albuterol eMDPI Digital System, to Optimize Outcomes in Patients at Least 13 Years of Age or Older With Asthma', 'orgStudyIdInfo': {'id': 'ABS-AS-40138'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Digital System (DS)', 'description': 'Participants will be trained on the use of the albuterol eMDPI DS (including instructions on how to use both the eMDPI and the App) and, upon demonstrating competency, will receive 2 albuterol eMDPI devices for use as reliever bronchodilators to replace their reliever treatment during the study. The eMDPI Digital System consists of 4 devices: Device 1: albuterol eMDPI (the test investigational medicinal product \\[IMP\\]); Device 2: Patient-facing App; Device 3: Digital health platform (DHP) (Cloud solution); and Device 4: Provider-facing Dashboard. Participants will receive 90 micrograms (mcg) albuterol, 1 to 2 oral inhalations every 4 to 6 hours, as needed for 12 weeks.', 'interventionNames': ['Drug: Albuterol eMDPI DS']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Concurrent Control (CC)', 'description': 'Participants will be treated with their standard of care albuterol-administering reliever inhalers and will use the digital system during the treatment period. Participants will be reimbursed or given a voucher to use to purchase their existing reliever medications.', 'interventionNames': ['Drug: albuterol']}], 'interventions': [{'name': 'Albuterol eMDPI DS', 'type': 'DRUG', 'description': 'Albuterol sulfate electronic multidose dry powder inhaler (Albuterol eMDPI) DS with 4 component devices:\n\n* Device 1: Albuterol eMDPI\n* Device 2: Albuterol eMDPI Patient-facing smart device application (App)\n* Device 3: DHP Cloud solution)\n* Device 4: Provider-facing dashboard (dashboard)', 'armGroupLabels': ['Digital System (DS)']}, {'name': 'albuterol', 'type': 'DRUG', 'description': 'Standard of care albuterol-administering rescue inhaler', 'armGroupLabels': ['Concurrent Control (CC)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Teva Investigational Site 14232', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90025', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 14302', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95207-6204', 'city': 'Stockton', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 14301', 'geoPoint': {'lat': 37.9577, 'lon': -121.29078}}, {'zip': '80907', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 14236', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 14198', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Teva Investigational Site 14220', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14197', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33186', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14306', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 14215', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '31707', 'city': 'Albany', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 14304', 'geoPoint': {'lat': 31.57851, 'lon': -84.15574}}, {'zip': '30501', 'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 14201', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'zip': '31406', 'city': 'Savannah', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 14195', 'geoPoint': {'lat': 32.08354, 'lon': -81.09983}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 14217', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Teva Investigational Site 14218', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '40215', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Teva Investigational Site 14305', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '42301', 'city': 'Owensboro', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Teva Investigational Site 14191', 'geoPoint': {'lat': 37.77422, 'lon': -87.11333}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'Teva Investigational Site 14233', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '68123-4303', 'city': 'Bellevue', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Teva Investigational Site 14207', 'geoPoint': {'lat': 41.13667, 'lon': -95.89084}}, {'zip': '10461', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 14221', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14234', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45231', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 14187', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 14210', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15241', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Teva Investigational Site 14208', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '02906', 'city': 'Providence', 'state': 'Rhode Island', 'country': 'United States', 'facility': 'Teva Investigational Site 14200', 'geoPoint': {'lat': 41.82399, 'lon': -71.41283}}, {'zip': '29407', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14300', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29607', 'city': 'Greenville', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 14196', 'geoPoint': {'lat': 34.85262, 'lon': -82.39401}}, {'zip': '78207', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 14188', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 14192', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78251', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 14189', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53228', 'city': 'Greenfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Teva Investigational Site 14190', 'geoPoint': {'lat': 42.9614, 'lon': -88.01259}}], 'overallOfficials': [{'name': 'Teva Medical Expert, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Teva Branded Pharmaceutical Products R&D, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Qualified researchers may request access to patient level data and related study documents including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient level data will be de-identified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}