Ignite Creation Date:
2025-12-24 @ 7:51 PM
Ignite Modification Date:
2026-01-05 @ 8:18 AM
Study NCT ID:
NCT04997304
Status:
COMPLETED
Last Update Posted:
2025-07-08
First Post:
2021-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Teva Asthma Predictive Analytics Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-03-30', 'type': 'ACTUAL'}}}}, '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': 'nlugogo@med.umich.edu', 'phone': '734-647-6477', 'title': 'Njira Lugogo', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 1 year', 'description': 'Adverse event data in arms 2, 3, and 4 reflect instances where an adverse event occurred within 1 month of the participant using the named intervention. Data reflects only participant use of the AirDuo and ProAir. Note: some participants on their own accord used a different product instead of, or in conjunction with, the AirDuo or ProAir. Usage of these other products, not being part of this pragmatic trial, were not tracked.', 'eventGroups': [{'id': 'EG000', 'title': 'Not Using Either AirDuo or ProAir', 'description': 'Participants used neither inhaler during the course of the trial.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 7, 'seriousNumAtRisk': 16, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG001', 'title': 'After Using AirDuo', 'description': 'Data reflects participants who experienced an AE within 1 month of using the AirDuo.', 'otherNumAtRisk': 84, 'deathsNumAtRisk': 84, 'otherNumAffected': 7, 'seriousNumAtRisk': 84, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'After Using ProAir', 'description': 'Data reflects participants who experienced an AE within 1 month of using the ProAir. 73 participants used ProAir at all during the trial.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 1, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG003', 'title': 'After Using Both AirDuo and ProAir', 'description': 'Data reflects participants who experienced an AE within 1 month of using both AirDuo and ProAir inhalers together.73 participants used both AirDuo and ProAir during the trial.', 'otherNumAtRisk': 73, 'deathsNumAtRisk': 73, 'otherNumAffected': 18, 'seriousNumAtRisk': 73, 'deathsNumAffected': 0, 'seriousNumAffected': 8}], 'otherEvents': [{'term': 'Covid 19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 9}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sinus Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Upper Respiratory Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Lung Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Tremors & Generalized Weakness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Influenza A', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Covid 19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Adrenal Crisis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Gastroparesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Graham Negative Rod Bacteremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Asthma Exacerbation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 4}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pulmonary Embolism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiomyopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Post-surgical low oxygen', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 84, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 73, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 73, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Number of Daily Doses of ProAir® Digihaler™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ProAir® Digihaler', 'description': "Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis."}], 'classes': [{'categories': [{'measurements': [{'value': '0.55', 'spread': '0.95', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 year', 'description': 'This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler device, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses taken by participant divided by their number of days of follow-up.', 'unitOfMeasure': 'doses per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the ProAir® Digihaler™.'}, {'type': 'PRIMARY', 'title': 'Mean Number of Daily Doses AirDuo® Digihaler™.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AirDuo® Digihaler', 'description': "Participants were provided with the AirDuo® Digihaler™ inhaler, which they could choose to use or not. If taken, participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled maintenance therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis."}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'spread': '0.76', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'up to 1 year', 'description': 'This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses for a given participant divided by their number of days of follow-up.', 'unitOfMeasure': 'doses per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the AirDuo® Digihaler™.'}, {'type': 'PRIMARY', 'title': 'Median Number of Daily Doses of ProAir® Digihaler™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'ProAir® Digihaler', 'description': "Participants were provided with the ProAir® Digihaler™ 90mcg inhaler, which they could choose to use or not. If taken, participants would receive a dose that was equivalent to the participants' current inhaled therapy dose. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis."}], 'classes': [{'categories': [{'measurements': [{'value': '0.21', 'groupId': 'OG000', 'lowerLimit': '0.03', 'upperLimit': '0.52'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 1 year', 'description': 'This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.', 'unitOfMeasure': 'doses per day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the ProAir® Digihaler™.'}, {'type': 'PRIMARY', 'title': 'Median Number of Daily Doses of AirDuo® Digihaler™', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AirDuo® Digihaler', 'description': "Participants were provided with the AirDuo® Digihaler™ inhaler, which they could choose to use or not. If taken, participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled maintenance therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis."}], 'classes': [{'categories': [{'measurements': [{'value': '0.99', 'groupId': 'OG000', 'lowerLimit': '0.21', 'upperLimit': '1.66'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'up to 1 year', 'description': 'This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.', 'unitOfMeasure': 'doses per day', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the AirDuo® Digihaler™.'}, {'type': 'SECONDARY', 'title': 'Maintenace Inhaler Adherence Rates', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AirDuo® Digihaler', 'description': "Participants were provided with the AirDuo® Digihaler™ inhaler, which they could choose to use or not. If taken, participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled maintenance therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis."}], 'classes': [{'title': 'High (>80% of puffs)', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}]}]}, {'title': 'Moderate (50-80% of puffs)', 'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}, {'title': 'Low levels (<50% of puffs)', 'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 year', 'description': 'This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Adherence rates were measured by the following: High (\\>80% of puffs), moderate (50-80% of puffs), and low levels (\\<50% of puffs) of adherence to maintenance inhalers over the course of the trial.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the outcome measure concerned adherence, all participants were included in this outcome, regardless of whether they chose to use the AirDuo® Digihaler™.'}, {'type': 'SECONDARY', 'title': 'Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AirDuo and ProAir', 'description': "This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.\n\nAirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.\n\nProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year."}], 'classes': [{'title': 'Non-response', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Partial response', 'categories': [{'measurements': [{'value': '82', 'groupId': 'OG000'}]}]}, {'title': 'Complete response', 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 1 year', 'description': 'All participants were provided the AirDuo® and ProAir® Digihalers, which they could choose to use or not. Responses were categorized as non-response, partial response, and complete response on the basis of five factors: a 50% reduction in exacerbations, any reduction in maintenance oral corticosteroids (OCS) dose, change of at least 10% in forced expiratory volume in one second (FEV1), improvement of 3 points in asthma control test (ACT) score, and patient perception of global improvement in asthma. Non-response indicated that a participant had no response to any of the 5 factors. Partial response indicated that a participant responded to at least 1 factor. Complete response indicated that a participant responded to all 5 factors.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Because the outcome measure concerned response to biologics, all participants were included in this outcome, regardless of whether they chose to use either Digihaler or not.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Peak Inhalation Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AirDuo and ProAir', 'description': "This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.\n\nAirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.\n\nProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year."}], 'classes': [{'title': 'Baseline - AirDuo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2436.48', 'spread': '1328.27', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up/Exacerbation - AirDuo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2041.79', 'spread': '803.00', 'groupId': 'OG000'}]}]}, {'title': 'Baseline - ProAir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2147.69', 'spread': '1201.34', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up/Exacerbation - ProAir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1833.74', 'spread': '806.61', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0019', 'groupIds': ['OG000'], 'groupDescription': 'This analysis applies only to comparison of baseline and exacerbation for AirDuo', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Paired t-test', 'nonInferiorityComment': 'Test of paired differences'}, {'pValue': '0.0020', 'groupIds': ['OG000'], 'groupDescription': 'This analysis applies only to comparison of baseline and exacerbation for ProAir', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Paired t-test', 'nonInferiorityComment': 'Test of paired differences'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 1 year', 'description': 'Peak inhalation volume is the maximum air volume a person can breathe in during a deep inhalation, serving as an indicator of lung capacity and respiratory function. Peak inhalation volume was measured by the digital inhaler at the end of inhalation. This measures the maximum volume that the participant was able to draw into their lungs. Larger numbers indicated healthier lungs.', 'unitOfMeasure': 'milliliters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Because the ProAir is a rescue inhaler, not all individuals used it, so the number of participants involved is smaller.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Inspiratory Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AirDuo and ProAir', 'description': "This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.\n\nAirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.\n\nProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year."}], 'classes': [{'title': 'Baseline - AirDuo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2002.99', 'spread': '853.03', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up/Exacerbation - AirDuo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1755.44', 'spread': '692.41', 'groupId': 'OG000'}]}]}, {'title': 'Baseline - ProAir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2268.19', 'spread': '919.78', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up/Exacerbation - ProAir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1982.48', 'spread': '756.34', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.0008', 'groupIds': ['OG000'], 'groupDescription': 'This analysis applies only to comparison of baseline and exacerbation for AirDuo', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Paired t-test', 'nonInferiorityComment': 'Test of paired differences'}, {'pValue': '0.0003', 'groupIds': ['OG000'], 'groupDescription': 'This analysis applies only to comparison of baseline and exacerbation for ProAir', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Paired t-test', 'nonInferiorityComment': 'Test of paired differences'}], 'paramType': 'MEAN', 'timeFrame': 'baseline to 1 year', 'description': 'Inspiratory time was the total time taken to complete an inspiration (i.e., breathing in). Results were differences between the baseline and exacerbation measurements.', 'unitOfMeasure': 'Seconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Because the ProAir is a rescue inhaler, not all individuals used it, so the number of participants involved is smaller.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Peak Inspiratory Flow (PIF)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AirDuo and ProAir', 'description': "This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.\n\nAirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.\n\nProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year."}], 'classes': [{'title': 'Baseline - AirDuo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '103.41', 'spread': '35.02', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up/Exacerbation - AirDuo', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '99.04', 'spread': '29.58', 'groupId': 'OG000'}]}]}, {'title': 'Baseline - ProAir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '79.60', 'spread': '27.08', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up/Exacerbation - ProAir', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '77.14', 'spread': '23.61', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000'], 'groupDescription': 'This analysis applies only to comparison of baseline and exacerbation for AirDuo', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Paired t-test', 'nonInferiorityComment': 'Test of paired differences'}, {'pValue': '0.0965', 'groupIds': ['OG000'], 'groupDescription': 'This analysis applies only to comparison of baseline and exacerbation for ProAir', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Paired t-test', 'nonInferiorityComment': 'Test of paired differences'}], 'paramType': 'MEAN', 'timeFrame': 'baseline up to 1 year', 'description': 'PIF is the maximum rate of airflow a person can inhale using an inhaler after a full breath. PIF was measured by the ProAir® Digihaler™ and AirDuo® Digihaler™. Results indicate the changes between the baseline and exacerbation measurements.', 'unitOfMeasure': 'Liters per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Because the ProAir is a rescue inhaler, not all individuals used it, so the number of participants involved is smaller.'}, {'type': 'SECONDARY', 'title': 'Change in Mean Forced Expiratory Volume in One Second (FEV1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AirDuo and ProAir', 'description': "This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.\n\nAirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.\n\nProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year."}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '66.07', 'spread': '20.34', 'groupId': 'OG000'}]}]}, {'title': 'Follow Up/Exacerbation', 'categories': [{'measurements': [{'value': '68.43', 'spread': '19.47', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline up to 1 year', 'description': 'FEV1 was measured using the Go Spiro Spirometer. Results indicate the difference between the baseline and exacerbation measurements.', 'unitOfMeasure': 'Liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Measurements were taken for those participants who experienced an exacerbation and compared to their baseline values. Home spirometry was not consistently used by all participants.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Exacerbations', 'timeFrame': 'up to 1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Hospitalizations', 'timeFrame': 'up to 1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Emergency Room Visits', 'timeFrame': 'up to 1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Mean Asthma Control Test (ACT) Score', 'timeFrame': 'up to 1 year', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AirDuo and ProAir', 'description': "This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.\n\nAirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.\n\nProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '100'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '26'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '11'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AirDuo and ProAir', 'description': "This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.\n\nAirDuo Digihaler: Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.\n\nProAir Digihaler: Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year."}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '50.8', 'spread': '14.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '66', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '34', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '94', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '16', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '76', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-12-17', 'size': 627641, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-12-20T10:42', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-07-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-19', 'studyFirstSubmitDate': '2021-07-11', 'resultsFirstSubmitDate': '2025-03-10', 'studyFirstSubmitQcDate': '2021-08-02', 'lastUpdatePostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-19', 'studyFirstPostDateStruct': {'date': '2021-08-09', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Number of Exacerbations', 'timeFrame': 'up to 1 year'}, {'measure': 'Number of Hospitalizations', 'timeFrame': 'up to 1 year'}, {'measure': 'Number of Emergency Room Visits', 'timeFrame': 'up to 1 year'}, {'measure': 'Mean Asthma Control Test (ACT) Score', 'timeFrame': 'up to 1 year'}], 'primaryOutcomes': [{'measure': 'Mean Number of Daily Doses of ProAir® Digihaler™', 'timeFrame': 'up to 1 year', 'description': 'This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler device, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses taken by participant divided by their number of days of follow-up.'}, {'measure': 'Mean Number of Daily Doses AirDuo® Digihaler™.', 'timeFrame': 'up to 1 year', 'description': 'This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the sum total of doses for a given participant divided by their number of days of follow-up.'}, {'measure': 'Median Number of Daily Doses of ProAir® Digihaler™', 'timeFrame': 'up to 1 year', 'description': 'This outcome measured participant adherence to using the ProAir® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.'}, {'measure': 'Median Number of Daily Doses of AirDuo® Digihaler™', 'timeFrame': 'up to 1 year', 'description': 'This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Subject-specific result was calculated as the 50th percentile value of all daily dose totals (or the average of two 50th percentile values if there was a tie) calculated over the number of days of follow-up.'}], 'secondaryOutcomes': [{'measure': 'Maintenace Inhaler Adherence Rates', 'timeFrame': 'up to 1 year', 'description': 'This outcome measured participant adherence to using the AirDuo® Digihaler™. All participants were provided the Digihaler, which they could choose to use or not. Adherence rates were measured by the following: High (\\>80% of puffs), moderate (50-80% of puffs), and low levels (\\<50% of puffs) of adherence to maintenance inhalers over the course of the trial.'}, {'measure': 'Participants Who Achieved Non-response, Partial Response, and Complete Response to Biologics', 'timeFrame': 'up to 1 year', 'description': 'All participants were provided the AirDuo® and ProAir® Digihalers, which they could choose to use or not. Responses were categorized as non-response, partial response, and complete response on the basis of five factors: a 50% reduction in exacerbations, any reduction in maintenance oral corticosteroids (OCS) dose, change of at least 10% in forced expiratory volume in one second (FEV1), improvement of 3 points in asthma control test (ACT) score, and patient perception of global improvement in asthma. Non-response indicated that a participant had no response to any of the 5 factors. Partial response indicated that a participant responded to at least 1 factor. Complete response indicated that a participant responded to all 5 factors.'}, {'measure': 'Change in Mean Peak Inhalation Volume', 'timeFrame': 'baseline to 1 year', 'description': 'Peak inhalation volume is the maximum air volume a person can breathe in during a deep inhalation, serving as an indicator of lung capacity and respiratory function. Peak inhalation volume was measured by the digital inhaler at the end of inhalation. This measures the maximum volume that the participant was able to draw into their lungs. Larger numbers indicated healthier lungs.'}, {'measure': 'Change in Mean Inspiratory Time', 'timeFrame': 'baseline to 1 year', 'description': 'Inspiratory time was the total time taken to complete an inspiration (i.e., breathing in). Results were differences between the baseline and exacerbation measurements.'}, {'measure': 'Change in Mean Peak Inspiratory Flow (PIF)', 'timeFrame': 'baseline up to 1 year', 'description': 'PIF is the maximum rate of airflow a person can inhale using an inhaler after a full breath. PIF was measured by the ProAir® Digihaler™ and AirDuo® Digihaler™. Results indicate the changes between the baseline and exacerbation measurements.'}, {'measure': 'Change in Mean Forced Expiratory Volume in One Second (FEV1)', 'timeFrame': 'baseline up to 1 year', 'description': 'FEV1 was measured using the Go Spiro Spirometer. Results indicate the difference between the baseline and exacerbation measurements.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Adults', 'Severe persistent', 'AirDuo Digihaler', 'ProAir Digihaler'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This trial is being completed to determine baseline inhalation parameters and patterns of use in patients receiving treatment with TEVA digital inhalers, to develop predictive models for asthma exacerbations and response to biologics using data collected from these devices.\n\nEnrolled participants will complete questionnaires along with other study specific procedures. Additionally, in-person and phone visits will be performed.', 'detailedDescription': 'All participants were provided an AirDuo® Digihaler™ and ProAirDuo® Digihaler™, which the participants could choose to use or not. This trial did not restrict participants from using other asthma treatments in addition to or in lieu of the Digihalers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* A history of severe persistent asthma as defined by European Respiratory Society (ERS) and American Thoracic Society (ERS/ATS) criteria which includes the presence of poor asthma control on high dose inhaled corticosteroid (ICS) and a long-acting beta-agonist (CS/LABA) or the need for high dose ICS/LABA to maintain asthma control or oral steroids for maintenance therapy for more than 50% of the prior year.\n* Presence of current biologic use or planned initiation of biologics following study enrollment\n* Patients will be categorized on the basis of asthma control (Asthma Control Test (ACT)\\< 19 will be considered poor asthma control). The study will cap the patients with good asthma control at 30% and will no longer enroll those patients once the strata have been fully enrolled.\n* Willingness to switch maintenance inhalers to AirDuo® Digihaler™ and to use ProAir® Digihaler™ for rescue therapy. Use of nebulized albuterol will be discouraged but not prohibited.\n* 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 study application\n* Ability to provide informed consent.\n* The patient must be willing and able to comply with study requirements and restrictions\n\nExclusion Criteria:\n\n* Clinically important pulmonary disease other than asthma including Chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, cystic fibrosis, or other lung disease\n* Any disorder that is either not stable or could in the opinion of the investigator affect the ability of the subject to safely participate in the study or could adversely affect study results.\n* History of human immunodeficiency virus or other immunodeficiency syndrome\n* Malignancy other than skin cancer that has occurred within the past year and that will impact survival thus limit participation in the clinical trial\n* History of chronic alcohol abuse or drug use\n* Any life-threatening diseases that will impact the patient's ability to complete the 12-month study period"}, 'identificationModule': {'nctId': 'NCT04997304', 'briefTitle': 'Teva Asthma Predictive Analytics Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Utilizing Advances in Digital Inhaler Technology to Understand Heterogeneous Treatment Responses to Biologics in Severe Asthma', 'orgStudyIdInfo': {'id': 'HUM00189756'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AirDuo and ProAir', 'description': 'This trial includes using the inhaler (AirDuo®) Digihaler™ and rescue inhalers (ProAir®) Digihaler™.', 'interventionNames': ['Combination Product: AirDuo Digihaler', 'Combination Product: ProAir Digihaler']}], 'interventions': [{'name': 'AirDuo Digihaler', 'type': 'COMBINATION_PRODUCT', 'description': "Participants will receive the AirDuo® Digihaler™ at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. This medication will be administered twice daily. The study and treatment will last 1 year.\n\nParticipants will also use a home spirometry device and smart device application (app) will be used to track medication usage and allow users to self-assess their respiratory symptoms on a daily basis.", 'armGroupLabels': ['AirDuo and ProAir']}, {'name': 'ProAir Digihaler', 'type': 'COMBINATION_PRODUCT', 'description': "Participants will receive the ProAir® Digihaler™ 90mcg at a dose that is equivalent to the participants' current inhaled therapy dose. Most participants will likely require the high dose inhaler: 232/14 device. The ProAir® Digihaler™ will be utilized up to six times per day as needed for acute asthma symptoms. The study and treatment will last 1 year.", 'armGroupLabels': ['AirDuo and ProAir']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Njira Lugogo, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Njira Lugogo', 'investigatorAffiliation': 'University of Michigan'}}}}