Ignite Creation Date:
2025-12-25 @ 4:16 AM
Ignite Modification Date:
2025-12-26 @ 3:16 AM
Study NCT ID:
NCT01698320
Status:
COMPLETED
Last Update Posted:
2015-08-19
First Post:
2012-09-14
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety Study of Albuterol Spiromax® in Subjects 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ustevatrials@tevapharm.com', 'phone': '1-215-591-3000', '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': 'Day 1 to Week 52', 'eventGroups': [{'id': 'EG000', 'title': 'Albuterol MDPI - Double-blind Period', 'description': 'Albuterol multi-dose dry powder inhaler (MDPI or Spiromax) at a dose of 720 micrograms per day administered as 2 inhalations of 90 mcg /inhalation four times a day for the 12 week double-blind period.', 'otherNumAtRisk': 168, 'otherNumAffected': 51, 'seriousNumAtRisk': 168, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo MDPI - Double-blind Period', 'description': 'Placebo delivered using a multi-dose dry powder inhaler (MDPI or Spiromax) as 2 inhalations four times a day for the 12 week double-blind period.', 'otherNumAtRisk': 170, 'otherNumAffected': 80, 'seriousNumAtRisk': 170, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Albuterol MDPI (Formerly Placebo) - Open Label Period', 'description': 'After completing 12 weeks of placebo QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).', 'otherNumAtRisk': 169, 'otherNumAffected': 64, 'seriousNumAtRisk': 169, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Albuterol MDPI (Formerly Albuterol) - Open Label Period', 'description': 'After completing 12 weeks of albuterol QID treatment, participants continue into the 40 week open-label period in which they administer albuterol multi-dose dry powder inhaler (Spiromax) inhalations of 90 mcg/inhalation as required (PRN).', 'otherNumAtRisk': 168, 'otherNumAffected': 67, 'seriousNumAtRisk': 168, 'seriousNumAffected': 4}], 'otherEvents': [{'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 10, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 7, 'numAffected': 6}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 22, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 20, 'numAffected': 16}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 26, 'numAffected': 20}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 9, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 14, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 23, 'numAffected': 19}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 26, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 36, 'numAffected': 31}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 36, 'numAffected': 27}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 16, 'numAffected': 15}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 19, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 16, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 25, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 18, 'numAffected': 10}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 19, 'numAffected': 18}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 14, 'numAffected': 11}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Oropharyngeal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 7, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 11, 'numAffected': 11}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 10, 'numAffected': 10}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'seriousEvents': [{'term': 'Atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Flank pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Gastrointestinal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Pancreatic carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Papillary thyroid cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Abortion spontaneous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Pregnancy, puerperium and perinatal conditions', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Nephrolithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}, {'term': 'Asthma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 170, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 169, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 168, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}, {'id': 'OG001', 'title': 'Albuterol MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '105', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}]}, {'title': 'Severe adverse event', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related adverse event', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other serious adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Withdrawn from treatment due to adverse events', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1 to Week 12', 'description': 'Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include 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 patient and required medical intervention to prevent the previously listed serious outcomes.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Composite Measurement of Device Ruggedness From Baseline to Week 52', 'timeFrame': 'Baseline to Week 52', 'description': 'Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Device Invitro Evaluations to Week 52', 'timeFrame': 'Baseline to Week 52', 'description': 'Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows:\n\n* Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing\n* Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing', 'reportingStatus': 'NOT_POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Daily AM Peak Expiratory Flow (PEF) to Week 52', 'timeFrame': 'Baseline to Week 52', 'description': "Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler.", 'reportingStatus': 'NOT_POSTED'}, {'type': 'PRIMARY', 'title': 'Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '165', 'groupId': 'OG000'}, {'value': '156', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}, {'id': 'OG001', 'title': 'Albuterol MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}], 'classes': [{'title': 'Any adverse event', 'categories': [{'measurements': [{'value': '106', 'groupId': 'OG000'}, {'value': '94', 'groupId': 'OG001'}]}]}, {'title': 'Severe adverse event', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-related adverse event', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Deaths', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Other serious adverse events', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}, {'title': 'Withdrawn from treatment due to adverse events', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 13-52', 'description': 'Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include 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 patient and required medical intervention to prevent the previously listed serious outcomes.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population'}, {'type': 'PRIMARY', 'title': 'Electrocardiogram (ECG) Results At Weeks 0, 12, and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}, {'id': 'OG001', 'title': 'Albuterol MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}], 'classes': [{'title': 'Week 0: Normal', 'categories': [{'measurements': [{'value': '151', 'groupId': 'OG000'}, {'value': '154', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: Abnormal, not clinically relevant', 'categories': [{'measurements': [{'value': '19', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Week 0: Abnormal, clinically relevant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Normal (n=166, 155)', 'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Abnormal, not clinically relevant', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Week 12: Abnormal, clinically relevant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Normal (n=152, 161)', 'categories': [{'measurements': [{'value': '138', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Abnormal, not clinically relevant', 'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Week 52: Abnormal, clinically relevant', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0 (screening visit), 12, and 52', 'description': 'A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Participants with assessments at each time point are reported.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}, {'id': 'OG001', 'title': 'Albuterol MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}], 'classes': [{'title': 'Systolic BP Week 12 (n=166, 155)', 'categories': [{'measurements': [{'value': '1.0', 'spread': '11.27', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '10.99', 'groupId': 'OG001'}]}]}, {'title': 'Systolic BP Week 52 (n=159, 155)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '11.54', 'groupId': 'OG000'}, {'value': '0.7', 'spread': '10.31', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP Week 12 (n=166, 155)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '9.16', 'groupId': 'OG000'}, {'value': '0.3', 'spread': '7.62', 'groupId': 'OG001'}]}]}, {'title': 'Diastolic BP Week 52 (n=159, 155)', 'categories': [{'measurements': [{'value': '0.2', 'spread': '9.14', 'groupId': 'OG000'}, {'value': '1.0', 'spread': '8.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 12 and Week 52', 'description': 'Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer.\n\nWeek 12 values represent change from Week 0. Week 52 values represent change from Week 12.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Participants with assessments at each time point are reported.'}, {'type': 'PRIMARY', 'title': 'Change From Baseline in Pulse Measurements to Week 12 and Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}, {'id': 'OG001', 'title': 'Albuterol MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}], 'classes': [{'title': 'Pulse Week 12 (n=166, 155)', 'categories': [{'measurements': [{'value': '-0.1', 'spread': '9.40', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '9.53', 'groupId': 'OG001'}]}]}, {'title': 'Pulse Week 52 (n=159, 155)', 'categories': [{'measurements': [{'value': '-0.4', 'spread': '10.08', 'groupId': 'OG000'}, {'value': '-0.3', 'spread': '9.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Week 0, Week 12 and Week 52', 'description': 'Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse.\n\nWeek 12 values represent change from Week 0. Week 52 values represent change from Week 12.', 'unitOfMeasure': 'beats/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Participants with assessments at each time point are reported.'}, {'type': 'PRIMARY', 'title': 'Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '170', 'groupId': 'OG000'}, {'value': '168', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}, {'id': 'OG001', 'title': 'Albuterol MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}], 'classes': [{'title': 'General appearance - Week 0 (n=170, 167)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'General appearance - Week 12 (n=166, 155)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'General appearance - Week 52 (n=162, 161)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HEENT - Week 0 (n=170, 167)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'HEENT - Week 12 (n=166, 155)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'HEENT - Week 52 (n=162, 161)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Chest and lungs - Week 0 (n=170, 167)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Chest and lungs - Week 12 (n=166, 155)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Chest and lungs - Week 52 (n=162, 161)', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}, {'title': 'Heart - Week 0 (n=170, 167)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heart - Week 12 (n=166, 155)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Heart - Week 52 (n=162, 161)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdomen - Week 0 (n=168, 167)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdomen - Week 12 (n=166, 155)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Abdomen - Week 52 (n=162, 161)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal - Week 0 (n=169, 167)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal - Week 12 (n=166, 155)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Musculoskeletal - Week 52 (n=162, 161)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin - Week 0 (n=169, 167)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin - Week 12 (n=167, 155)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Skin - Week 52 (n=162, 161)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Nodes - Week 0 (n=169, 167)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Nodes - Week 120 (n=166, 155)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Lymph Nodes - Week 52 (n=162, 161)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neurological - Week 0 (n=169, 167)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neurological - Week 12 (n=166, 155)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Neurological - Week 52 (n=162, 161)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Extremities/back - Week 0 (n=169, 167)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Extremities/back - Week 12 (n=166, 155)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Extremities/back - Week 52 (n=162, 160)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Weeks 0, 12 and 52', 'description': 'The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional.\n\nHEENT = head, eyes, ears, nose, throat', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety population. Participants with assessments at each time point are reported.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'All Enrolled Subjects', 'description': 'Includes subjects who were enrolled in study and participated in the single-blind (subjects were blinded) run-in period in which subjects used the inhaler with placebo and maintained the diary for about one week prior to randomization and starting the 12-week double-blind period.'}, {'id': 'FG001', 'title': 'Placebo MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}, {'id': 'FG002', 'title': 'Albuterol MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}], 'periods': [{'title': 'Run-In Period (Week -1 to Day 0)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '364'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '337'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '27'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Inclusion/exclusion criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': '12-Week Double-Blind Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '169'}, {'groupId': 'FG002', 'numSubjects': '168'}]}, {'type': 'Safety Population', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': 'One participant took both placebo and albuterol so is counted in both treatment groups for safety.', 'groupId': 'FG001', 'numSubjects': '170'}, {'groupId': 'FG002', 'numSubjects': '168'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '165'}, {'groupId': 'FG002', 'numSubjects': '156'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '12'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Sponsor requested subject withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '4'}]}]}, {'title': '40-Week Open-Label Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '165'}, {'groupId': 'FG002', 'numSubjects': '156'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '146'}, {'groupId': 'FG002', 'numSubjects': '146'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '11'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Pregnancy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Sponsor requested subject withdrawal', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Of the 33 patients who were screened but not enrolled, 28 were excluded on the basis of inclusion/exclusion criteria, 2 patients withdrew consent, and 3 patients were lost to follow-up before the baseline visit.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'BG000'}, {'value': '168', 'groupId': 'BG001'}, {'value': '337', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}, {'id': 'BG001', 'title': 'Albuterol MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '37.1', 'spread': '15.14', 'groupId': 'BG000'}, {'value': '36.6', 'spread': '15.04', 'groupId': 'BG001'}, {'value': '36.8', 'spread': '15.07', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '12-17 years', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '44', 'groupId': 'BG002'}]}]}, {'title': '18-64 years', 'categories': [{'measurements': [{'value': '143', 'groupId': 'BG000'}, {'value': '135', 'groupId': 'BG001'}, {'value': '278', 'groupId': 'BG002'}]}]}, {'title': '65+ years', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '103', 'groupId': 'BG001'}, {'value': '214', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '58', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '123', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '125', 'groupId': 'BG001'}, {'value': '254', 'groupId': 'BG002'}]}]}, {'title': 'Black', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '73', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaskan Native', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Pacific Islander', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic or Latino', 'categories': [{'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '140', 'groupId': 'BG001'}, {'value': '284', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Weight', 'classes': [{'categories': [{'measurements': [{'value': '82.3', 'spread': '21.09', 'groupId': 'BG000'}, {'value': '81.2', 'spread': '21.4', 'groupId': 'BG001'}, {'value': '81.8', 'spread': '21.22', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Height', 'classes': [{'categories': [{'measurements': [{'value': '167.4', 'spread': '8.67', 'groupId': 'BG000'}, {'value': '168.6', 'spread': '9.52', 'groupId': 'BG001'}, {'value': '168.0', 'spread': '9.11', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'cm', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index', 'classes': [{'categories': [{'measurements': [{'value': '29.2', 'spread': '6.96', 'groupId': 'BG000'}, {'value': '28.5', 'spread': '6.81', 'groupId': 'BG001'}, {'value': '28.8', 'spread': '6.88', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'Full analysis set of randomized subjects'}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 364}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'dispFirstSubmitDate': '2014-05-08', 'completionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-12', 'studyFirstSubmitDate': '2012-09-14', 'dispFirstSubmitQcDate': '2014-05-08', 'resultsFirstSubmitDate': '2015-07-13', 'studyFirstSubmitQcDate': '2012-09-28', 'dispFirstPostDateStruct': {'date': '2014-05-26', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-12', 'studyFirstPostDateStruct': {'date': '2012-10-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-08-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Composite Measurement of Device Ruggedness From Baseline to Week 52', 'timeFrame': 'Baseline to Week 52', 'description': 'Device Ruggedness: Reports of any problems/malfunction of the device (e.g., lack of efficacy, problems/malfunction after the device is dropped or sustains physical impact).'}, {'measure': 'Device Invitro Evaluations to Week 52', 'timeFrame': 'Baseline to Week 52', 'description': 'Device In Vitro Evaluations - All used study inhalers will be collected and a random selection of inhalers will be tested as follows:\n\n* Fifty (50) Albuterol Spiromax® inhalers used during weeks 0-12 will be randomly selected for in vitro testing\n* Fifty (50) Albuterol Spiromax® inhalers used during weeks 12-52 will be randomly selected for in vitro performance testing'}, {'measure': 'Daily AM Peak Expiratory Flow (PEF) to Week 52', 'timeFrame': 'Baseline to Week 52', 'description': "Daily AM PEF will be recorded throughout the duration of the study to provide information on the subject's asthma status in order to assist in distinguishing between the use of back-up rescue medication related to an increased need for asthma symptom relief from that related to an issue with the Albuterol Spiromax® rescue inhaler."}], 'primaryOutcomes': [{'measure': 'Participants With Adverse Experiences During Weeks 0-12 (Double-Blind Period)', 'timeFrame': 'Day 1 to Week 12', 'description': 'Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include 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 patient and required medical intervention to prevent the previously listed serious outcomes.'}, {'measure': 'Participants With Adverse Experiences During Weeks 13-52 (Open-Label Period)', 'timeFrame': 'Weeks 13-52', 'description': 'Adverse events (AEs) summarized in this table are those that began or worsened after treatment with study drug (treatment-emergent AEs). An adverse event was defined in the protocol as any untoward medical occurrence that develops or worsens in severity during the conduct of a clinical study and does not necessarily have a causal relationship to the study drug. Severity was rated by the investigator on a scale of mild, moderate and severe, with severe= an AE which prevents normal daily activities. Relation of AE to treatment was determined by the investigator. Serious AEs include 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 patient and required medical intervention to prevent the previously listed serious outcomes.'}, {'measure': 'Electrocardiogram (ECG) Results At Weeks 0, 12, and 52', 'timeFrame': 'Weeks 0 (screening visit), 12, and 52', 'description': 'A standard 12-lead ECG was performed at screening, week 12, and week 52 or early termination/discontinuation. The ECG recording methods were centralized and standardized across all study participants. A centralized cardiologist was responsible for providing all ECG interpretations.'}, {'measure': 'Change From Baseline in Blood Pressure Measurements to Week 12 and Week 52', 'timeFrame': 'Week 0, Week 12 and Week 52', 'description': 'Participants were seated at least 2 minutes before blood pressure measurements were obtained by either an electronic or manual sphygmomanometer.\n\nWeek 12 values represent change from Week 0. Week 52 values represent change from Week 12.'}, {'measure': 'Change From Baseline in Pulse Measurements to Week 12 and Week 52', 'timeFrame': 'Week 0, Week 12 and Week 52', 'description': 'Participants were seated at least 2 minutes before pulse measurements were obtained by radial pulse.\n\nWeek 12 values represent change from Week 0. Week 52 values represent change from Week 12.'}, {'measure': 'Participants With Abnormal and Clinically Relevant Physical Exam Findings at Weeks 0, 12 and 52', 'timeFrame': 'Weeks 0, 12 and 52', 'description': 'The physical exam was performed by a qualified healthcare professional, and when possible, the same qualified healthcare professional that performed the physical examination at study screening performed all the scheduled physical examinations. Abnormalities and clinical relevance were determined by the qualified healthcare professional.\n\nHEENT = head, eyes, ears, nose, throat'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'referencesModule': {'references': [{'pmid': '26369589', 'type': 'DERIVED', 'citation': "Raphael G, Taveras H, Iverson H, O'Brien C, Miller D. Twelve- and 52-week safety of albuterol multidose dry powder inhaler in patients with persistent asthma. J Asthma. 2016;53(2):187-93. doi: 10.3109/02770903.2015.1070862. Epub 2015 Sep 15."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety of Albuterol Spiromax® over 52 weeks during two dosing periods: (1) a 12-week, double-blind, placebo-controlled QID dosing period followed by (2) a 40-week, open-label PRN dosing period, and to evaluate Albuterol Spiromax® device performance through the life of the device during the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Written informed consent and HIPAA signed and dated by the subject or written informed assent signed and dated both by the subject and/or parent/caregiver/legal guardian before conducting any study related procedure.\n* Males or females with asthma ages 12 years or older at screening.\n* Documented history of persistent asthma and current use of an MDI containing any short-acting beta-adrenergic agonist (e.g. albuterol, levalbuterol,) on average of at least once/week over the 4-weeks prior to screening. The asthma diagnosis must be consistent with the diagnosis of asthma as per the National Asthma Education and Prevention Program.\n* If female, is currently not pregnant, breast feeding, or attempting to become pregnant (for 4 weeks before the screening visit and throughout the duration of the study), and is of Non-childbearing potential, defined as:\n\n * ≥1 year post-menopausal or\n * Surgically sterile (tubal ligation, bilateral oophorectomy, salpingectomy, or hysterectomy) or is of\n * Childbearing potential, has a negative serum pregnancy test, and is willing to commit to using a consistent and acceptable method of birth control\n* General good health in the opinion of the investigator as indicated by medical history, physical examination, laboratory tests (hematology, serum chemistry and urinalysis) assessed as either normal or abnormal not clinically significant (NCS) per the principal investigator, as well as a 12-lead ECG interpreted as either "Normal" or "Abnormal NCS" as determined by the central cardiologist. Subjects must also be free of any clinically significant, uncontrolled concomitant conditions other than asthma that could interfere with study conduct, influence the interpretation of study observations/results, or put the subject at increased risk during the trial.\n* Capable of understanding the requirements, risks, and benefits of study participation, and, as judged by the investigator, and being compliant with all study requirements (visits, record-keeping, etc).\n* Non-smoker for at least one year prior to the screening visit and a maximum pack-year (PY) smoking history of 10 years.\n* Able to demonstrate proper inhaler technique with study inhaler.\n\nExclusion Criteria:\n\n* Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the subject\'s last study related visit.\n* Participation in any investigational drug trial within 30 days preceding the screening visit or planned participation in another investigational drug trial at any time during this trial.\n* A known hypersensitivity to albuterol or any of the excipients in the formulations.\n* History of severe milk protein allergy\n* History of an upper or lower respiratory tract infection or disorder (including, but not limited to bronchitis, pneumonia, acute or chronic sinusitis, otitis media, influenza, etc) which is not resolved at least 1 week prior to the SV.\n* History of alcohol or drug abuse within two years preceding the SV.\n* Use of any protocol prohibited concomitant medications for asthma (any oral β2-adrenergic agonists) or any protocol prohibited concomitant non-asthma medications including treatment with β2-adrenergic receptor antagonists and non-selective β-receptor blocking agents such as β-blocking anti-hypertensive products (administered by any route), MAO inhibitors, and/or tricyclic antidepressants. (Subject\'s own MDI short-acting β-agonist rescue inhaler should be used until the start of the Run-In period when a study rescue inhaler is provided.)\n* Inability or unwillingness to comply with the protocol requirements.\n* History of life-threatening asthma \\[defined here as an asthma episode requiring intubation and/or associated with hypercapnea, respiratory arrest or hypoxic seizures.\\]\n* Any asthma exacerbation within 3 months of the SV requiring oral or systemic corticosteroids or any hospitalization for asthma within 6 months of the SV.\n\nNote: An exacerbation of asthma is defined as any worsening of asthma requiring any treatment other than rescue albuterol or the subject\'s regular asthma maintenance therapy. This includes requiring the use of systemic corticosteroids and/or emergency room visit or hospitalization or a change in subject\'s regular asthma maintenance treatment. A subject does not need to be withdrawn from the study due to an asthma exacerbation unless hospitalization is required or unless the principal investigator believes it is in the subjects\' best interest to withdraw from the study.\n\n* Previous participation in an inhaled Albuterol Spiromax® (Teva) study, with the exception of the ABS-AS-306 study.\n* Study participation by clinical investigator site employees and/or their immediate relatives.\n* Study participation by related or non-related individuals living in the same household, i.e. only one subject per household may participate in the study.\n* Any clinically significant endocrine, hematological, hepatic, renal, gastrointestinal, neurological, cardiac, metabolic, immunological, any non-asthmatic acute or chronic pulmonary condition (including but not limited to bronchitis, emphysema, active tuberculosis, bronchiectasis, cystic fibrosis), and malignancy other than basal cell carcinoma. Significant is defined for this protocol as any condition that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which could affect the safety analyses.\n* Any medical or psychological condition that in the investigator\'s opinion should preclude enrollment.'}, 'identificationModule': {'nctId': 'NCT01698320', 'briefTitle': 'Safety Study of Albuterol Spiromax® in Subjects With Asthma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Teva Branded Pharmaceutical Products R&D, Inc.'}, 'officialTitle': 'A Multi-Center 52-Week Study to Assess the Safety of Albuterol Spiromax® in Subjects With Asthma', 'orgStudyIdInfo': {'id': 'ABS-AS-307'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of placebo MDPI (multi-dose dry powder inhaler), four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.', 'interventionNames': ['Drug: Placebo MDPI', 'Drug: Albuterol MDPI']}, {'type': 'EXPERIMENTAL', 'label': 'Albuterol MDPI-Albuterol MDPI', 'description': 'During the 12-week double-blind period, participants take 2 inhalations of albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation, four times a day (QID) at approximately 7:00 AM, 12:00 PM, 5:00 PM, and bedtime for a total daily dose of 720 micrograms per day.\n\nThe double-blind period is followed by a 40-week open-label period in which all study participants take albuterol MDPI 90 micrograms/inhalation, 2 inhalations every 4-6 hours as needed (PRN) and, if applicable, 2 inhalations 15-30 minutes prior to sports/exercise.', 'interventionNames': ['Drug: Albuterol MDPI']}], 'interventions': [{'name': 'Placebo MDPI', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'Placebo MDPI (multi-dose dry powder inhaler) to match the active intervention.', 'armGroupLabels': ['Placebo MDPI-Albuterol MDPI']}, {'name': 'Albuterol MDPI', 'type': 'DRUG', 'otherNames': ['ProAir® RespiClick', 'Albuterol Spiromax'], 'description': 'Albuterol MDPI (multi-dose dry powder inhaler or Spiromax®) 90 mcg/inhalation.', 'armGroupLabels': ['Albuterol MDPI-Albuterol MDPI', 'Placebo MDPI-Albuterol MDPI']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 10169', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Teva Investigational Site 10157', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 10148', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Teva Investigational Site 10159', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 10158', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'Teva Investigational Site 10168', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'city': 'Gainesville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Teva Investigational Site 10154', 'geoPoint': {'lat': 34.29788, 'lon': -83.82407}}, {'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Teva Investigational Site 10161', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Teva Investigational Site 10162', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'city': 'Wheaton', 'state': 'Maryland', 'country': 'United States', 'facility': 'Teva Investigational Site 10166', 'geoPoint': {'lat': 39.03983, 'lon': -77.05526}}, {'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Teva Investigational Site 10151', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'city': 'Plymouth', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Teva Investigational Site 10142', 'geoPoint': {'lat': 45.01052, 'lon': -93.45551}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Teva Investigational Site 10152', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Bellevue', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Teva Investigational Site 10146', 'geoPoint': {'lat': 41.13667, 'lon': -95.89084}}, {'city': 'Skillman', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Teva Investigational Site 10160', 'geoPoint': {'lat': 40.42011, 'lon': -74.7146}}, {'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Teva Investigational Site 10144', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'city': 'High Point', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 10141', 'geoPoint': {'lat': 35.95569, 'lon': -80.00532}}, {'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Teva Investigational Site 10153', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'city': 'Canton', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 10147', 'geoPoint': {'lat': 40.79895, 'lon': -81.37845}}, {'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 10143', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'city': 'Sylvania', 'state': 'Ohio', 'country': 'United States', 'facility': 'Teva Investigational Site 10167', 'geoPoint': {'lat': 41.71894, 'lon': -83.71299}}, {'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Teva Investigational Site 10150', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Teva Investigational Site 10156', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'El Paso', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 10155', 'geoPoint': {'lat': 31.75872, 'lon': -106.48693}}, {'city': 'New Braunfels', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 10149', 'geoPoint': {'lat': 29.703, 'lon': -98.12445}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 10145', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Teva Investigational Site 10170', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Burke', 'state': 'Virginia', 'country': 'United States', 'facility': 'Teva Investigational Site 10163', 'geoPoint': {'lat': 38.79345, 'lon': -77.27165}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Teva Investigational Site 10165', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Greenfield', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Teva Investigational Site 10164', 'geoPoint': {'lat': 42.9614, 'lon': -88.01259}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Teva Branded Pharmaceutical Products R&D, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}