Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-30 @ 8:35 PM
Study NCT ID:
NCT01349803
Status:
COMPLETED
Last Update Posted:
2017-01-31
First Post:
2011-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
PT003 MDI Cardiovascular Safety Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068759', 'term': 'Formoterol Fumarate'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'creisner@pearltherapeutics.com', 'phone': '973-975-0320', 'title': 'Colin Reisner, MD, FCCP, FAAAAI', 'organization': 'Pearl Therapeutics, Inc'}, 'certainAgreement': {'otherDetails': 'Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent its opinions, or the opinions of the publication committee, if these differ with the proposed publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) and Serious Adverse Events (SAEs) were collected from the time the subject signs the informed consent form up to 14 days following the last dose of study drug.', 'description': 'All patients who were randomized to a treatment, received at least one dose of the study treatment, and had any safety data after starting study treatment. A patient who used a study treatment, but took less than one full dose qualified for this population.', 'eventGroups': [{'id': 'EG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg', 'otherNumAtRisk': 60, 'otherNumAffected': 6, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg', 'otherNumAtRisk': 58, 'otherNumAffected': 4, 'seriousNumAtRisk': 58, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg', 'otherNumAtRisk': 60, 'otherNumAffected': 2, 'seriousNumAtRisk': 60, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg', 'otherNumAtRisk': 59, 'otherNumAffected': 5, 'seriousNumAtRisk': 59, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Tremor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Chronic obstructive pulmonary disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 60, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 59, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in 24-Hour Mean Heart Rate Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.19', 'groupId': 'OG000', 'lowerLimit': '-1.38', 'upperLimit': '1.00'}, {'value': '-1.84', 'groupId': 'OG001', 'lowerLimit': '-3.05', 'upperLimit': '-0.63'}, {'value': '0.40', 'groupId': 'OG002', 'lowerLimit': '-0.84', 'upperLimit': '1.63'}, {'value': '-0.09', 'groupId': 'OG003', 'lowerLimit': '-1.32', 'upperLimit': '1.15'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '14 days', 'description': 'The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD).', 'unitOfMeasure': 'bpm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Mean FEV1 Trough', 'denoms': [{'units': 'Participants', 'counts': [{'value': '57', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}, {'value': '53', 'groupId': 'OG002'}, {'value': '55', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.091', 'groupId': 'OG000', 'lowerLimit': '0.049', 'upperLimit': '0.134'}, {'value': '0.126', 'groupId': 'OG001', 'lowerLimit': '0.080', 'upperLimit': '0.172'}, {'value': '0.251', 'groupId': 'OG002', 'lowerLimit': '0.207', 'upperLimit': '0.295'}, {'value': '0.124', 'groupId': 'OG003', 'lowerLimit': '0.081', 'upperLimit': '0.167'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Day 7 to Day 14', 'description': 'Trough FEV1 averaged over Day 7 and Day 14', 'unitOfMeasure': 'Liters', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'MITT - patients from the ITT population who completed at least one evaluable FEV1 spirometry assessment for baseline (pre-dose on Day 1) and had an evaluable FEV1 spirometry assessment on at least one of the following: Day 7 pre-dose or Day 14 pre-dose (or both).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg'}], 'classes': [{'categories': [{'measurements': [{'value': '0.56', 'groupId': 'OG000', 'lowerLimit': '-0.73', 'upperLimit': '1.85'}, {'value': '-0.44', 'groupId': 'OG001', 'lowerLimit': '-1.75', 'upperLimit': '0.87'}, {'value': '0.92', 'groupId': 'OG002', 'lowerLimit': '-0.40', 'upperLimit': '2.24'}, {'value': '0.31', 'groupId': 'OG003', 'lowerLimit': '-1.01', 'upperLimit': '1.63'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '24 hours', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'bpm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Daytime Mean Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=59 Day 14: N=59'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=58 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.00', 'groupId': 'OG000', 'lowerLimit': '-1.40', 'upperLimit': '1.40'}, {'value': '-0.52', 'groupId': 'OG001', 'lowerLimit': '-1.93', 'upperLimit': '0.90'}, {'value': '0.16', 'groupId': 'OG002', 'lowerLimit': '-1.27', 'upperLimit': '1.58'}, {'value': '-0.17', 'groupId': 'OG003', 'lowerLimit': '-1.60', 'upperLimit': '1.25'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '-1.22', 'groupId': 'OG000', 'lowerLimit': '-2.64', 'upperLimit': '0.20'}, {'value': '-2.00', 'groupId': 'OG001', 'lowerLimit': '-3.45', 'upperLimit': '-0.56'}, {'value': '-0.40', 'groupId': 'OG002', 'lowerLimit': '-1.87', 'upperLimit': '1.07'}, {'value': '-0.54', 'groupId': 'OG003', 'lowerLimit': '-2.01', 'upperLimit': '0.93'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'bpm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Night Time Mean Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '59', 'groupId': 'OG000'}, {'value': '57', 'groupId': 'OG001'}, {'value': '55', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=59 Day 14: N=58'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=57 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=55 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '3.05', 'groupId': 'OG000', 'lowerLimit': '1.63', 'upperLimit': '4.47'}, {'value': '-0.54', 'groupId': 'OG001', 'lowerLimit': '-1.99', 'upperLimit': '0.90'}, {'value': '2.95', 'groupId': 'OG002', 'lowerLimit': '1.48', 'upperLimit': '4.42'}, {'value': '0.70', 'groupId': 'OG003', 'lowerLimit': '-0.74', 'upperLimit': '2.15'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.04', 'groupId': 'OG000', 'lowerLimit': '-1.94', 'upperLimit': '2.03'}, {'value': '-0.88', 'groupId': 'OG001', 'lowerLimit': '-2.89', 'upperLimit': '1.12'}, {'value': '0.11', 'groupId': 'OG002', 'lowerLimit': '-1.93', 'upperLimit': '2.15'}, {'value': '1.05', 'groupId': 'OG003', 'lowerLimit': '-0.99', 'upperLimit': '3.09'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'bpm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-Hour Maximum Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=58 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '-4.71', 'groupId': 'OG000', 'lowerLimit': '-8.72', 'upperLimit': '-0.69'}, {'value': '-1.88', 'groupId': 'OG001', 'lowerLimit': '-5.96', 'upperLimit': '2.20'}, {'value': '-1.91', 'groupId': 'OG002', 'lowerLimit': '-6.03', 'upperLimit': '2.21'}, {'value': '0.31', 'groupId': 'OG003', 'lowerLimit': '-3.81', 'upperLimit': '4.42'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.75', 'groupId': 'OG000', 'lowerLimit': '-3.46', 'upperLimit': '4.97'}, {'value': '-2.21', 'groupId': 'OG001', 'lowerLimit': '-6.50', 'upperLimit': '2.07'}, {'value': '-0.06', 'groupId': 'OG002', 'lowerLimit': '-4.42', 'upperLimit': '4.31'}, {'value': '-1.13', 'groupId': 'OG003', 'lowerLimit': '-5.49', 'upperLimit': '3.23'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'bpm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in 24-Hour Minimum Heart Rate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=58 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.05', 'groupId': 'OG000', 'lowerLimit': '-1.19', 'upperLimit': '1.29'}, {'value': '-0.03', 'groupId': 'OG001', 'lowerLimit': '-1.30', 'upperLimit': '1.23'}, {'value': '0.50', 'groupId': 'OG002', 'lowerLimit': '-0.78', 'upperLimit': '1.78'}, {'value': '0.45', 'groupId': 'OG003', 'lowerLimit': '-0.82', 'upperLimit': '1.72'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '-0.79', 'groupId': 'OG000', 'lowerLimit': '-1.92', 'upperLimit': '0.35'}, {'value': '-1.92', 'groupId': 'OG001', 'lowerLimit': '-3.07', 'upperLimit': '-0.77'}, {'value': '-0.21', 'groupId': 'OG002', 'lowerLimit': '-1.38', 'upperLimit': '0.97'}, {'value': '0.88', 'groupId': 'OG003', 'lowerLimit': '-0.30', 'upperLimit': '2.05'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'bpm', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=58 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '1.31', 'spread': '1.605', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.24'}, {'value': '0.56', 'spread': '0.853', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '0.18'}, {'value': '1.59', 'spread': '1.879', 'groupId': 'OG002', 'lowerLimit': '-0.19', 'upperLimit': '0.31'}, {'value': '0.45', 'spread': '0.580', 'groupId': 'OG003', 'lowerLimit': '-0.24', 'upperLimit': '0.26'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '3.09', 'spread': '4.092', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.16'}, {'value': '0.62', 'spread': '1.088', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '-0.03'}, {'value': '-0.10', 'spread': '0.541', 'groupId': 'OG002', 'lowerLimit': '-0.17', 'upperLimit': '0.31'}, {'value': '-0.54', 'spread': '0.424', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'Ventricular events / hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=58 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.09', 'spread': '0.071', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.24'}, {'value': '0.00', 'spread': '0.005', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '0.18'}, {'value': '0.00', 'spread': '0.009', 'groupId': 'OG002', 'lowerLimit': '-0.19', 'upperLimit': '0.31'}, {'value': '0.00', 'spread': '0.005', 'groupId': 'OG003', 'lowerLimit': '-0.24', 'upperLimit': '0.26'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.02', 'spread': '0.021', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.16'}, {'value': '0.00', 'spread': '0.009', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '-0.03'}, {'value': '-0.03', 'spread': '0.033', 'groupId': 'OG002', 'lowerLimit': '-0.17', 'upperLimit': '0.31'}, {'value': '-0.01', 'spread': '0.004', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'Ventricular couplets / hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=58 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '-0.003', 'spread': '0.0024', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.24'}, {'value': '-0.001', 'spread': '0.0017', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '0.18'}, {'value': '0.001', 'spread': '0.0019', 'groupId': 'OG002', 'lowerLimit': '-0.19', 'upperLimit': '0.31'}, {'value': '-0.003', 'spread': '0.0040', 'groupId': 'OG003', 'lowerLimit': '-0.24', 'upperLimit': '0.26'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '-0.004', 'spread': '0.0021', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.16'}, {'value': '0.001', 'spread': '0.0029', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '-0.03'}, {'value': '0.001', 'spread': '0.0013', 'groupId': 'OG002', 'lowerLimit': '-0.17', 'upperLimit': '0.31'}, {'value': '-0.004', 'spread': '0.0037', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'Ventricular runs / hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=58 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '7.72', 'spread': '6.971', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.24'}, {'value': '0.74', 'spread': '0.804', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '0.18'}, {'value': '-4.55', 'spread': '5.947', 'groupId': 'OG002', 'lowerLimit': '-0.19', 'upperLimit': '0.31'}, {'value': '15.36', 'spread': '16.359', 'groupId': 'OG003', 'lowerLimit': '-0.24', 'upperLimit': '0.26'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '3.61', 'spread': '5.179', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.16'}, {'value': '-9.29', 'spread': '9.398', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '-0.03'}, {'value': '3.61', 'spread': '5.179', 'groupId': 'OG002', 'lowerLimit': '-0.17', 'upperLimit': '0.31'}, {'value': '5.81', 'spread': '11.320', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'Supraventricular events / hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=58 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.03', 'spread': '0.034', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.24'}, {'value': '0.01', 'spread': '0.021', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '0.18'}, {'value': '0.05', 'spread': '0.019', 'groupId': 'OG002', 'lowerLimit': '-0.19', 'upperLimit': '0.31'}, {'value': '0.04', 'spread': '0.065', 'groupId': 'OG003', 'lowerLimit': '-0.24', 'upperLimit': '0.26'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.025', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.16'}, {'value': '0.00', 'spread': '0.017', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '-0.03'}, {'value': '0.00', 'spread': '0.018', 'groupId': 'OG002', 'lowerLimit': '-0.17', 'upperLimit': '0.31'}, {'value': '-0.02', 'spread': '0.020', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'Supraventricular couplets / hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=58 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '0.00', 'spread': '0.014', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.24'}, {'value': '0.02', 'spread': '0.011', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '0.18'}, {'value': '0.01', 'spread': '0.011', 'groupId': 'OG002', 'lowerLimit': '-0.19', 'upperLimit': '0.31'}, {'value': '0.01', 'spread': '0.010', 'groupId': 'OG003', 'lowerLimit': '-0.24', 'upperLimit': '0.26'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '0.01', 'spread': '0.013', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.16'}, {'value': '0.02', 'spread': '0.015', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '-0.03'}, {'value': '0.00', 'spread': '0.012', 'groupId': 'OG002', 'lowerLimit': '-0.17', 'upperLimit': '0.31'}, {'value': '0.01', 'spread': '0.014', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'Supraventricular runs / hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=58 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '-0.04', 'spread': '0.139', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.24'}, {'value': '-0.02', 'spread': '0.083', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '0.18'}, {'value': '0.11', 'spread': '0.193', 'groupId': 'OG002', 'lowerLimit': '-0.19', 'upperLimit': '0.31'}, {'value': '0.03', 'spread': '0.036', 'groupId': 'OG003', 'lowerLimit': '-0.24', 'upperLimit': '0.26'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '-0.02', 'spread': '0.111', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.16'}, {'value': '0.40', 'spread': '0.210', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '-0.03'}, {'value': '0.27', 'spread': '0.283', 'groupId': 'OG002', 'lowerLimit': '-0.17', 'upperLimit': '0.31'}, {'value': '0.13', 'spread': '0.132', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'Bradycardia episodes / hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '57', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg Day 1: N=60 Day 14: N=59'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg Day 1: N=58 Day 14: N=57'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg Day 1: N=57 Day 14: N=55'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg Day 1: N=57 Day 14: N=55'}], 'classes': [{'title': 'Day 1', 'categories': [{'measurements': [{'value': '-0.16', 'spread': '0.170', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.24'}, {'value': '-0.24', 'spread': '0.209', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '0.18'}, {'value': '-0.02', 'spread': '0.160', 'groupId': 'OG002', 'lowerLimit': '-0.19', 'upperLimit': '0.31'}, {'value': '-0.09', 'spread': '0.197', 'groupId': 'OG003', 'lowerLimit': '-0.24', 'upperLimit': '0.26'}]}]}, {'title': 'Day 14', 'categories': [{'measurements': [{'value': '-0.23', 'spread': '0.146', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.16'}, {'value': '-0.34', 'spread': '0.229', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '-0.03'}, {'value': '0.22', 'spread': '0.154', 'groupId': 'OG002', 'lowerLimit': '-0.17', 'upperLimit': '0.31'}, {'value': '-0.01', 'spread': '0.206', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.52'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'Tachycardia episodes / hour', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Holter Monitoring Population: a sub-set of the safety population that had at least 18 hours of Holter monitoring data at Screening and at Day 1 and/or Day 14. Exclusions from this population were identified prior to database lock and unblinding.'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in QTcF Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'OG000'}, {'value': '58', 'groupId': 'OG001'}, {'value': '60', 'groupId': 'OG002'}, {'value': '59', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg'}, {'id': 'OG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg'}, {'id': 'OG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg'}, {'id': 'OG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg'}], 'classes': [{'title': 'Day 1: Post-dose 30 minutes', 'categories': [{'measurements': [{'value': '1.53', 'spread': '11.238', 'groupId': 'OG000', 'lowerLimit': '-0.25', 'upperLimit': '0.24'}, {'value': '4.67', 'spread': '12.548', 'groupId': 'OG001', 'lowerLimit': '-0.32', 'upperLimit': '0.18'}, {'value': '3.27', 'spread': '9.223', 'groupId': 'OG002', 'lowerLimit': '-0.19', 'upperLimit': '0.31'}, {'value': '3.71', 'spread': '9.816', 'groupId': 'OG003', 'lowerLimit': '-0.24', 'upperLimit': '0.26'}]}]}, {'title': 'Day 1: Post-dose 2 hours', 'categories': [{'measurements': [{'value': '1.75', 'spread': '13.861', 'groupId': 'OG000', 'lowerLimit': '-0.31', 'upperLimit': '0.16'}, {'value': '3.57', 'spread': '12.866', 'groupId': 'OG001', 'lowerLimit': '-0.50', 'upperLimit': '-0.03'}, {'value': '1.62', 'spread': '13.785', 'groupId': 'OG002', 'lowerLimit': '-0.17', 'upperLimit': '0.31'}, {'value': '5.25', 'spread': '11.709', 'groupId': 'OG003', 'lowerLimit': '0.04', 'upperLimit': '0.52'}]}]}, {'title': 'Day 1: Post-dose 24 hours', 'categories': [{'measurements': [{'value': '-0.09', 'spread': '13.309', 'groupId': 'OG000'}, {'value': '1.23', 'spread': '16.142', 'groupId': 'OG001'}, {'value': '-1.43', 'spread': '12.724', 'groupId': 'OG002'}, {'value': '0.36', 'spread': '10.989', 'groupId': 'OG003'}]}]}, {'title': 'Day 7: Pre-dose', 'categories': [{'measurements': [{'value': '-1.80', 'spread': '10.362', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '14.713', 'groupId': 'OG001'}, {'value': '1.06', 'spread': '12.151', 'groupId': 'OG002'}, {'value': '3.85', 'spread': '12.599', 'groupId': 'OG003'}]}]}, {'title': 'Day 14: Pre-dose', 'categories': [{'measurements': [{'value': '-0.59', 'spread': '12.523', 'groupId': 'OG000'}, {'value': '1.79', 'spread': '13.028', 'groupId': 'OG001'}, {'value': '-0.42', 'spread': '11.910', 'groupId': 'OG002'}, {'value': '1.53', 'spread': '14.085', 'groupId': 'OG003'}]}]}, {'title': 'Day 14: Post-dose 30 minutes', 'categories': [{'measurements': [{'value': '1.21', 'spread': '13.350', 'groupId': 'OG000'}, {'value': '4.10', 'spread': '17.202', 'groupId': 'OG001'}, {'value': '2.23', 'spread': '13.194', 'groupId': 'OG002'}, {'value': '1.20', 'spread': '14.458', 'groupId': 'OG003'}]}]}, {'title': 'Day 14: Post-dose 2 hours', 'categories': [{'measurements': [{'value': '0.44', 'spread': '12.521', 'groupId': 'OG000'}, {'value': '6.02', 'spread': '16.774', 'groupId': 'OG001'}, {'value': '5.01', 'spread': '14.861', 'groupId': 'OG002'}, {'value': '3.98', 'spread': '14.135', 'groupId': 'OG003'}]}]}, {'title': 'Day 14: Post-dose 24 hours', 'categories': [{'measurements': [{'value': '-1.32', 'spread': '12.738', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '13.794', 'groupId': 'OG001'}, {'value': '-1.93', 'spread': '11.269', 'groupId': 'OG002'}, {'value': '1.44', 'spread': '16.086', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Day 1, Day 7, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg'}, {'id': 'FG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg'}, {'id': 'FG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg'}, {'id': 'FG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '60'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '60'}, {'groupId': 'FG003', 'numSubjects': '59'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '59'}, {'groupId': 'FG001', 'numSubjects': '57'}, {'groupId': 'FG002', 'numSubjects': '57'}, {'groupId': 'FG003', 'numSubjects': '57'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '2'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Protocol-specified criteria', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Conducted at 15 sites throughout the US, Australia, and New Zealand from May 2011 - November 2011. Study participation was a maximum of 7 weeks.', 'preAssignmentDetails': 'Study was a multicenter, randomized, double-blind, parallel group, chronic dosing (14 days) study; each patient was randomized to receive 1 of 4 possible treatments over the course of a 14-day treatment period'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '60', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '60', 'groupId': 'BG002'}, {'value': '59', 'groupId': 'BG003'}, {'value': '237', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'FF MDI (PT005)', 'description': 'FF MDI 9.6 mcg'}, {'id': 'BG001', 'title': 'GP MDI (PT001)', 'description': 'GP MDI 36 mcg'}, {'id': 'BG002', 'title': 'GFF MDI (PT003)', 'description': 'GFF MDI 36/9.6 mcg'}, {'id': 'BG003', 'title': 'Foradil® Aerolizer®', 'description': 'Formoterol Fumarate 12 μg'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.1', 'spread': '8.13', 'groupId': 'BG000'}, {'value': '63.3', 'spread': '7.93', 'groupId': 'BG001'}, {'value': '64.3', 'spread': '7.38', 'groupId': 'BG002'}, {'value': '64.1', 'spread': '7.91', 'groupId': 'BG003'}, {'value': '64.0', 'spread': '7.80', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '115', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Safety Population (all randomized subjects)'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 237}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'dispFirstSubmitDate': '2013-05-16', 'completionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-07', 'studyFirstSubmitDate': '2011-05-05', 'dispFirstSubmitQcDate': '2013-05-16', 'resultsFirstSubmitDate': '2016-05-24', 'studyFirstSubmitQcDate': '2011-05-06', 'dispFirstPostDateStruct': {'date': '2013-05-24', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-12-07', 'studyFirstPostDateStruct': {'date': '2011-05-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-01-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in 24-Hour Mean Heart Rate Post-dose', 'timeFrame': '14 days', 'description': 'The primary safety objective of this study was to compare the change in mean heart rate averaged over 24 hours post-dose, following twice daily dosing over 14 days with PT003 MDI, PT005 MDI, PT001 MDI or Foradil Aerolizer compared to baseline in patients with moderate to severe chronic obstructive pulmonary disease (COPD).'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Mean FEV1 Trough', 'timeFrame': 'Day 7 to Day 14', 'description': 'Trough FEV1 averaged over Day 7 and Day 14'}, {'measure': 'Change From Baseline in 24-Hour Mean Heart Rate for Day 1 of Treatment', 'timeFrame': '24 hours', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in Daytime Mean Heart Rate', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in Night Time Mean Heart Rate', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in 24-Hour Maximum Heart Rate', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in 24-Hour Minimum Heart Rate', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in Number of Isolated Ventricular Events Recorded During 24-Hour Holter Monitoring', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in the Number of Ventricular Couplets Recorded During 24-Hour Holter Monitoring', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in the Number of Ventricular Runs Recorded During 24-Hour Holter Monitoring', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in the Number of Isolated Supraventricular Events Recorded During 24-Hour Holter Monitoring', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in the Number of Supraventricular Couplets Recorded During 24-Hour Holter Monitoring', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in the Number of Supraventricular Runs Recorded During 24-Hour Holter Monitoring', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in the Number of Bradycardia Episodes Recorded During 24-Hour Holter Monitoring', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Change From Baseline in the Number of Tachycardia Episodes Recorded During 24-Hour Holter Monitoring', 'timeFrame': 'Baseline, Day 1, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}, {'measure': 'Mean Change From Baseline in QTcF Interval', 'timeFrame': 'Baseline, Day 1, Day 7, and Day 14', 'description': 'The secondary objectives of the study was to further characterize cardiovascular safety parameters of all treatment groups including the maximum 24-hour heart rate, mean night-time and day-time heart rate, ventricular ectopic events, ventricular couplets, ventricular runs, the number of supraventricular runs, and sustained ventricular tachycardia (VT), supraventricular ectopic events, and other clinically relevant arrhythmias (such as atrial fibrillation).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['COPD'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'referencesModule': {'references': [{'pmid': '29567116', 'type': 'DERIVED', 'citation': 'Ferguson GT, Reisner C, Pearle J, DePetrillo P, Maes A, Martin UJ. Cardiovascular safety profile of a fixed-dose combination of glycopyrrolate and formoterol fumarate delivered via metered dose inhaler using co-suspension delivery technology. Pulm Pharmacol Ther. 2018 Apr;49:67-74. doi: 10.1016/j.pupt.2018.01.007. Epub 2018 Feb 4.'}]}, 'descriptionModule': {'briefSummary': 'This study is primarily a safety study. The primary and secondary endpoints are based on 24-hour Holter monitor assessments obtained on Day 14 relative to baseline.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Signed written informed consent\n* 40 - 80 years of age\n* Clinical history of COPD with airflow limitation that is not fully reversible\n* Females of non-child bearing potential or females of child bearing potential with negative pregnancy test; and acceptable contraceptive methods\n* Current/former smokers with at least a 10 pack-year history of cigarette smoking\n* A measured post- bronchodilator FEV1/FVC ratio of \\< or = 0.70\n* A measured post- bronchodilator FEV1 \\> or = 750ml or 30% predicted and \\< or = 80% of predicted normal values\n* Able to change COPD treatment as required by protocol\n* Acceptable baseline (Visit 2) Holter monitor recording\n\nKey Exclusion Criteria:\n\n* Women who are pregnant or lactating\n* Primary diagnosis of asthma\n* Alpha-1 antitrypsin deficiency as the cause of COPD\n* Active pulmonary diseases\n* Prior lung volume reduction surgery\n* Abnormal chest X-ray (or CT scan) not due to the presence of COPD\n* Hospitalized due to poorly controlled COPD within 3 months of Screening\n* Clinically significant medical conditions that preclude participation in the study (e.g. clinically significant abnormal ECG, uncontrolled hypertension, glaucoma, symptomatic prostatic hypertrophy)\n* Cancer that has not been in complete remission for at least 5 years\n* Treatment with investigational study drug or participation in another clinical trial or study within the last 30 days or 5 half lives\n* Clinically significant abnormal findings during the baseline Holter recording\n* Patients with a pacemaker or ICD/CRT/CRT\\_D devices\n\nOther inclusion/exclusion criteria as defined by the protocol'}, 'identificationModule': {'nctId': 'NCT01349803', 'briefTitle': 'PT003 MDI Cardiovascular Safety Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pearl Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Double-blind, Parallel Group, 14-day, Multi-Center Study to Evaluate the Safety of PT003, PT005, PT001 and Foradil® Aerolizer® (12 µg, Open Label) as Evaluated by Holter Monitoring, in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)', 'orgStudyIdInfo': {'id': 'PT003003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PT005 MDI', 'description': 'PT005 MDI', 'interventionNames': ['Drug: PT005 MDI']}, {'type': 'EXPERIMENTAL', 'label': 'PT001 MDI', 'description': 'PT001 MDI', 'interventionNames': ['Drug: PT001 MDI']}, {'type': 'EXPERIMENTAL', 'label': 'PT003 MDI', 'description': 'PT003 MDI', 'interventionNames': ['Drug: PT003 MDI']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Formoterol Fumarate 12 μg (Foradil® Aerolizer®)', 'description': 'Formoterol Fumarate 12 μg (Foradil® Aerolizer®)', 'interventionNames': ['Drug: Formoterol Fumarate 12 μg (Foradil® Aerolizer®)']}], 'interventions': [{'name': 'PT005 MDI', 'type': 'DRUG', 'description': 'PT005 MDI administered as two puffs BID for 14 days', 'armGroupLabels': ['PT005 MDI']}, {'name': 'PT001 MDI', 'type': 'DRUG', 'description': 'PT001 MDI administered as two puffs BID for 14 days', 'armGroupLabels': ['PT001 MDI']}, {'name': 'PT003 MDI', 'type': 'DRUG', 'description': 'PT003 MDI administered as two puffs BID for 14 days', 'armGroupLabels': ['PT003 MDI']}, {'name': 'Formoterol Fumarate 12 μg (Foradil® Aerolizer®)', 'type': 'DRUG', 'otherNames': ['Foradil® Aerolizer®'], 'description': 'Formoterol Fumarate 12 μg (Foradil® Aerolizer®) administered BID for 14 days', 'armGroupLabels': ['Formoterol Fumarate 12 μg (Foradil® Aerolizer®)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 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