Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2026-02-21 @ 10:09 AM
Study NCT ID:
NCT02951312
Status:
COMPLETED
Last Update Posted:
2018-04-30
First Post:
2016-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered With an Electronic eFlow Nebulizer System in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}, {'id': 'D029481', 'term': 'Bronchitis, Chronic'}], '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'}, {'id': 'D001991', 'term': 'Bronchitis'}, {'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D001982', 'term': 'Bronchial Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'phone': '1-866-503-6351', 'title': 'Respiratory Medical Director', 'organization': 'Sunovion Pharmaceuticals Inc.'}, 'certainAgreement': {'otherDetails': 'In the event the Study is part of a multi-center study, the first publication of the results of the Study shall be made in conjunction with the results of other participating study sites as a multi-center publication; provided however, if a multi-center publication is not forthcoming within twenty-four (24) months following completion of the Study at all sites, Institution and Investigator shall be free to publish.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '0-47 days', 'description': "AE's are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment", 'eventGroups': [{'id': 'EG000', 'title': 'Glycopyrrolate Inhalation Solution 25 μg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Glycopyrrolate Inhalation Solution75μg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Glycopyrrolate Inhalation Solution 200 μg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily', 'otherNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer,', 'description': 'Glycopyrrolate Inhalation Solution 200μg Jet Nebulizer ,once daily\n\nGlycopyrrolate Inhalation Solution 200μg Jet Nebulizer, once daily', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Glycopyrrolate Inhalation Solution 500μg', 'description': 'Glycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500μg eFlow Nebulizer, once daily', 'otherNumAtRisk': 6, 'otherNumAffected': 0, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg via eFlow nebulizer, once daily', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'Placebo', 'description': 'Placebo\n\nPlacebo', 'otherNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'catheter site related reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'rhinitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}, {'term': 'cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 6, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (11.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects Who Died', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-47 days', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects who received at least one dose of study medication were included in the safety analysis.. A subject received more than one treatment type throughout the study.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment Emergent SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-47 days', 'description': 'AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects who received at least one dose of study medication were included in the safety analysis.. A subject received more than one treatment type throughout the study.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects Who Discontinued Due to AE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-47 days', 'description': 'AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.'}, {'type': 'PRIMARY', 'title': 'Percentage of Subjects With Treatment Emergent AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '33.3', 'groupId': 'OG001'}, {'value': '66.7', 'groupId': 'OG002'}, {'value': '33.3', 'groupId': 'OG003'}, {'value': '0.0', 'groupId': 'OG004'}, {'value': '33.3', 'groupId': 'OG005'}, {'value': '16.7', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '0-47 days', 'description': 'AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 hrs post dose', 'description': 'Vital signs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study assessment. The clinical significance of each out of normal range vital sign parameter was determined by the investigator during the study.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects who received at least one dose of study medication were included in the safety analysis. . A subject received more than one treatment type throughout the study.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'day 47 (post studyfollow-up assessment)', 'description': 'Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Clinically Significant ECG Parameters Reported During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30hr post dose', 'description': 'ECGs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study follow-up assessment.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '0', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'post study follow-up assessment (Day 47)', 'description': 'Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study.'}, {'type': 'PRIMARY', 'title': 'Number of Subjects With Treatment Emergent AEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '0', 'groupId': 'OG004'}, {'value': '2', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-47 days', 'description': 'AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects who received at least one dose of study medication were included in the safety analysis. A subject received more than one treatment type throughout the study'}, {'type': 'SECONDARY', 'title': 'Trough FEV1 (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.038', 'spread': '0.157', 'groupId': 'OG000'}, {'value': '0.087', 'spread': '0.062', 'groupId': 'OG001'}, {'value': '0.138', 'spread': '0.079', 'groupId': 'OG002'}, {'value': '-0.013', 'spread': '0.098', 'groupId': 'OG003'}, {'value': '-0.017', 'spread': '0.168', 'groupId': 'OG004'}, {'value': '0.065', 'spread': '0.072', 'groupId': 'OG005'}, {'value': '-0.030', 'spread': '0.070', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24hr post dose', 'description': 'Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the spirometry value collected at 24 hours post dose within each Treatment Period.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study medication and have at least one post baseline efficacy measurement were included in the efficacy population. A subject received more than one treatment type throughout the study.'}, {'type': 'SECONDARY', 'title': 'Peak FEV1 (Percent Change)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '17.12', 'spread': '9.07', 'groupId': 'OG000'}, {'value': '15.60', 'spread': '4.20', 'groupId': 'OG001'}, {'value': '22.98', 'spread': '4.99', 'groupId': 'OG002'}, {'value': '19.28', 'spread': '13.10', 'groupId': 'OG003'}, {'value': '11.47', 'spread': '6.86', 'groupId': 'OG004'}, {'value': '16.87', 'spread': '6.83', 'groupId': 'OG005'}, {'value': '6.80', 'spread': '2.91', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 4hr', 'description': 'Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.', 'unitOfMeasure': 'percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'all subjects who received at least one dose of the study medication and have at least one post baseline efficacy measurement were included in the efficacy population. . A subject received more than one treatment type throughout the study.'}, {'type': 'SECONDARY', 'title': 'Peak FEV1 (Change From Baseline )', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0.212', 'spread': '0.086', 'groupId': 'OG000'}, {'value': '0.255', 'spread': '0.068', 'groupId': 'OG001'}, {'value': '0.303', 'spread': '0.055', 'groupId': 'OG002'}, {'value': '0.233', 'spread': '0.144', 'groupId': 'OG003'}, {'value': '0.177', 'spread': '0.061', 'groupId': 'OG004'}, {'value': '0.283', 'spread': '0.069', 'groupId': 'OG005'}, {'value': '0.120', 'spread': '0.057', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 4hr', 'description': 'Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study medication and have at least one post baseline efficacy measurement were included in the efficacy population.. A subject received more than one treatment type throughout the study.'}, {'type': 'SECONDARY', 'title': 'FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}, {'value': '6', 'groupId': 'OG004'}, {'value': '6', 'groupId': 'OG005'}, {'value': '6', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 25mg: 25 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 75mg: 75 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG004', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG005', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG006', 'title': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily\n\nPlacebo: Placebo 0.5 mL oral inhalation via jet nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '1.59', 'spread': '3.27', 'groupId': 'OG000'}, {'value': '3.10', 'spread': '2.27', 'groupId': 'OG001'}, {'value': '3.19', 'spread': '1.14', 'groupId': 'OG002'}, {'value': '1.35', 'spread': '2.74', 'groupId': 'OG003'}, {'value': '1.53', 'spread': '2.05', 'groupId': 'OG004'}, {'value': '3.08', 'spread': '1.47', 'groupId': 'OG005'}, {'value': '-0.11', 'spread': '1.89', 'groupId': 'OG006'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 24hr post dose', 'description': 'Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.', 'unitOfMeasure': 'liters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study medication and have at least one post baselineefficacy measurement were included in the efficacy population. A subject received more than one treatment type throughout the study.'}, {'type': 'SECONDARY', 'title': 'Cmax Maximum Observed Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '177.242', 'spread': '61.469', 'groupId': 'OG000'}, {'value': '75.530', 'spread': '64.950', 'groupId': 'OG001'}, {'value': '749.872', 'spread': '219.696', 'groupId': 'OG002'}, {'value': '1534.057', 'spread': '442.581', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 12 hours post dose', 'description': 'Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK . A subject received more than one treatment type throughout the study.\n\nanalysis.'}, {'type': 'SECONDARY', 'title': 'Tmax Time to Maximum Observed Plasma Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '.025', 'spread': '0.088', 'groupId': 'OG000'}, {'value': '0.08', 'spread': '0.088', 'groupId': 'OG001'}, {'value': '0.25', 'spread': '0.069', 'groupId': 'OG002'}, {'value': '0.17', 'spread': '0.093', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 12 hours post dose', 'description': 'Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis. A subject received more than one treatment type throughout the study.'}, {'type': 'SECONDARY', 'title': 'AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '429.335', 'spread': '192.699', 'groupId': 'OG000'}, {'value': '26.176', 'spread': '16.170', 'groupId': 'OG001'}, {'value': '2014.276', 'spread': '609.911', 'groupId': 'OG002'}, {'value': '4084.763', 'spread': '827.225', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 12 hourr post dose', 'description': 'Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr', 'unitOfMeasure': 'pg*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis.A subject received more than one treatment type throughout the study.'}, {'type': 'SECONDARY', 'title': 'AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '563.416', 'spread': '235.418', 'groupId': 'OG000'}, {'value': '65.013', 'spread': '16.750', 'groupId': 'OG001'}, {'value': '2491.803', 'spread': '736.426', 'groupId': 'OG002'}, {'value': '5271.099', 'spread': '1096.862', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 12 hours post dose', 'description': 'Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr', 'unitOfMeasure': 'pg*h/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All subjects who received at least one dose of study medication and who have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis. A subject received more than one treatment type throughout the study.'}, {'type': 'SECONDARY', 'title': 't1/2 Plasma Half-life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}, {'value': '6', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg: 200 μg oral inhalation via eFlow Nebulizer, once daily'}, {'id': 'OG001', 'title': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 200mg Jet: 200 μg oral inhalation via inhalation via jet nebulizer, once daily'}, {'id': 'OG002', 'title': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution 500mg: 500 μg oral inhalation via eFlow nebulizer, once daily'}, {'id': 'OG003', 'title': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily\n\nGlycopyrrolate Inhalation Solution1000mg: 1000 μg oral inhalation via eFlow nebulizer, once daily'}], 'classes': [{'categories': [{'measurements': [{'value': '2.947', 'spread': '1.996', 'groupId': 'OG000'}, {'value': '0.778', 'spread': '0.465', 'groupId': 'OG001'}, {'value': '6.298', 'spread': '1.450', 'groupId': 'OG002'}, {'value': '7.573', 'spread': '1.031', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 12 hours post-dose', 'description': 'Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr.', 'unitOfMeasure': 'hour', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who received at least one dose of study medication and have sufficient blood samples taken to obtain a plasma concentration by time profile were included in the PK analysis.Subject received more than one treatment type throughout the study\n\nsamples taken to obtain a plasma concentration by time profile were included in the PK analysis.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '25mg Glycopyrrolate, 200mg Gloycopyrrolate', 'description': 'subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo'}, {'id': 'FG001', 'title': '75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate', 'description': 'subjects received 75mg Glycoprrolate, then, 500mg Glycopyrrolate, then 1000mg Glycopyrrolate in part 1 - in part 2 subjects from this group received either 200mg Glycopyrrolate or placebo'}, {'id': 'FG002', 'title': '200mg Glycopyrrolate Jet', 'description': 'subjects received 200mg Glycopyrrolate'}, {'id': 'FG003', 'title': 'Placebo', 'description': 'Subjects received placebo'}], 'periods': [{'title': 'Study Part 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}, {'title': 'Study Part 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '12', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': '25mg Glycopyrrolate, 200mg Gloycopyrrolate', 'description': 'subjects received 25mg Glycopyrrolate then 200mg Glycopyrrolate in part 1- in part 2 subjects from this group either received 200mg Glycopyrrolate or placebo'}, {'id': 'BG001', 'title': '75mg Glycopyrrolate,500mg Glycopyrrolate,1000mg Glycopyrrolate', 'description': 'subjects received 75mg Glycoprrolate, then, 500mg Glycopyrrolate, then 1000mg Glycopyrrolate in part 1 - in part 2 subjects from this group received either 200mg Glycopyrrolate or placebo'}, {'id': 'BG002', 'title': '200mg Glycopyrrolate Jet', 'description': 'subjects received 200mg Glycopyrrolate'}, {'id': 'BG003', 'title': 'Placebo', 'description': 'subjects received placebo'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.2', 'spread': '3.82', 'groupId': 'BG000'}, {'value': '63.5', 'spread': '8.89', 'groupId': 'BG001'}, {'value': '41.67', 'spread': '58.33', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All participants in study'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-03-28', 'studyFirstSubmitDate': '2016-10-26', 'resultsFirstSubmitDate': '2018-01-02', 'studyFirstSubmitQcDate': '2016-10-28', 'lastUpdatePostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-03-28', 'studyFirstPostDateStruct': {'date': '2016-11-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-04-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects Who Died', 'timeFrame': '0-47 days'}, {'measure': 'Number of Subjects With Treatment Emergent SAEs', 'timeFrame': '0-47 days', 'description': 'AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.'}, {'measure': 'Number of Subjects Who Discontinued Due to AE', 'timeFrame': '0-47 days', 'description': 'AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.'}, {'measure': 'Percentage of Subjects With Treatment Emergent AEs', 'timeFrame': '0-47 days', 'description': 'AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment.'}, {'measure': 'Number of Subjects With Clinically Significant Abnormal Vital Signs Reported During the Study', 'timeFrame': '30 hrs post dose', 'description': 'Vital signs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study assessment. The clinical significance of each out of normal range vital sign parameter was determined by the investigator during the study.'}, {'measure': 'Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study', 'timeFrame': 'day 47 (post studyfollow-up assessment)', 'description': 'Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.'}, {'measure': 'Number of Subjects With Clinically Significant ECG Parameters Reported During the Study', 'timeFrame': '30hr post dose', 'description': 'ECGs were measured at screening, during the study (pre-dose, and 30 and 60 minutes and 2, 4, 8, 12, 24 and 30 hours post-dose) and at post study follow-up assessment.'}, {'measure': 'Number of Subjects With Clinically Significant Abnormal Laboratory Results Reported During the Study', 'timeFrame': 'post study follow-up assessment (Day 47)', 'description': 'Clinical safety lab parameters were collected at screening and at the post study follow-up assessment. The clinical significance of each out of normal range laboratory parameter was determined by the investigator during the study.'}, {'measure': 'Number of Subjects With Treatment Emergent AEs', 'timeFrame': '0-47 days', 'description': 'AEs are defined as existing conditions which worsen or events which occur during the course of the clinical trial after treatment. SAEs are AEs that result in the following outcomes: death, are life-threatening, persistent or significant disability/incapacity, congenital anomaly/birth defect, or important medical events that may have been considered a SAE when, based upon appropriate medical judgment, they may have jeopardized the subject and may have required medical or surgical intervention to prevent one of the outcomes listed in the definition.'}], 'secondaryOutcomes': [{'measure': 'Trough FEV1 (Change From Baseline)', 'timeFrame': '24hr post dose', 'description': 'Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines. Trough FEV1 was defined as the spirometry value collected at 24 hours post dose within each Treatment Period.'}, {'measure': 'Peak FEV1 (Percent Change)', 'timeFrame': '0 to 4hr', 'description': 'Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.'}, {'measure': 'Peak FEV1 (Change From Baseline )', 'timeFrame': '0 to 4hr', 'description': 'Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.'}, {'measure': 'FEV1 AUC0-24 Area Under the FEV1 Over Time Curve (Change From Baseline)', 'timeFrame': '0 to 24hr post dose', 'description': 'Spirometry measurements were conducted in accordance with the current ATS/ERS 2005 guidelines.'}, {'measure': 'Cmax Maximum Observed Plasma Concentration', 'timeFrame': '0 to 12 hours post dose', 'description': 'Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr'}, {'measure': 'Tmax Time to Maximum Observed Plasma Concentration', 'timeFrame': '0 to 12 hours post dose', 'description': 'Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr'}, {'measure': 'AUC0-t Area Under the Plasma Concentration-time Curve From Time Zero to the Last Quantifiable Concentration', 'timeFrame': '0 to 12 hourr post dose', 'description': 'Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr'}, {'measure': 'AUC0-inf Area Under the Plasma Concentration-time Curve From Time Zero to Infinity', 'timeFrame': '0 to 12 hours post dose', 'description': 'Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr'}, {'measure': 't1/2 Plasma Half-life', 'timeFrame': '0 to 12 hours post-dose', 'description': 'Pk parameters are calculated from glycopyrrolate plasma concentration analysed from serial blood samples collected between 0 and 12 hr.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Emphysema', 'Chronic bronchitis', 'COPD', 'Chronic Obstructive Pulmonary Disease'], 'conditions': ['Chronic Obstructive Pulmonary Disease']}, 'descriptionModule': {'briefSummary': 'The study assessed the safety and ability of several doses of an orally inhaled medicine \\[ie, Glycopyrrolate Inhalation Solution = GIS\\] to improve airflow in the lungs when delivered with an electronic eFlow nebulizer system in patients with Chronic Obstructive Pulmonary Disease (COPD). The study was conducted in 12 patients in 2 parts. Part 1 was designed to find the once-a- day GIS dose that produced the highest improvement in lung airflow. Part 2 tested the GIS dose with the highest improvement in lung airflow and a placebo (ie, no drug) delivered by a general purpose nebulizer. The airflow improvements of the same GIS dose were compared between the two nebulizer systems to determine what effect the device had on GIS delivery.', 'detailedDescription': 'In Part I, 12 subjects were randomly allocated to one of 2 cohorts, running in parallel. The 6 cohort 1 subjects received 25 mg and then 200 mg during their treatment periods 1 and 2, respectively. The 6 cohort 2 subjects received 75mg, 500mg, and 1000 mg during their treatment periods 1, 2, and 3, respectively. During Part II of the study, the same 12 subjects from Part I were randomized to receive either 200 mg jet or placebo in a 1:1 ratio.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male and female patients aged 40 through 75 years, inclusive\n2. A clinical diagnosis of COPD according to the GOLD guidelines\n3. Current smokers or ex-smokers with at least 10 pack-year smoking history (e.g., at least 1 pack/day for 10 years, or 10 packs/day for 1 year)\n4. Post-bronchodilator FEV1 40-80% of predicted normal\n5. Post-bronchodilator FEV1/FVC ratio \\< 0.70\n6. Improvement in FEV1 \\>12% (minimum 150 mL) following inhalation of ipratropium bromide\n7. Ability to perform reproducible spirometry according to the ATS/ERS guidelines\n8. If female and of childbearing potential, must have had a negative pregnancy test and was not lactating at the Screening Visit, and was using one of the following acceptable means of birth control throughout the study:\n\n * Post-menopausal for at least two years\n * Surgically sterile\n * Oral contraceptives (taken for at least one month prior to the Screening Visit)\n * Approved implantable or injectable contraceptives (e.g., Norplant®, Depo-Provera® or equivalent)\n * Barrier methods (e.g., condoms with spermicide)\n * Intrauterine device (i.e., IUD)\n * Vasectomy of male partner\n * Non-heterosexual life style\n9. Willing and able to provide written informed consent\n\nExclusion Criteria:\n\n1. Current evidence or recent history of any clinically significant disease (other than COPD) or abnormality in the opinion of the Investigator that would put the patients at risk or which would compromise the quality of the study data; including but not limited to cardiovascular disease, myocardial infraction, hypertension, arrhythmia, diabetes, neurological or neuromuscular disease, liver disease, gastrointestinal disease or electrolyte abnormalities.\n2. Recent history of an exacerbation of airway disease within 3 months or need for increased treatments for COPD within 6 weeks prior to the Screening Visit.\n3. Regular use of daily oxygen therapy.\n4. Use of systemic (e.g., intramuscular or intravenous) steroids within 3 months prior to the Screening Visit\n5. Respiratory tract infection within 6 weeks prior to the Screening Visit\n6. History of tuberculosis, bronchiectasis or other non-specific pulmonary disease\n7. History of urinary retention or bladder neck obstruction type symptoms\n8. History of narrow-angle glaucoma\n9. Current or recent history (previous 12 months) of excessive use or abuse of alcohol\n10. Current evidence or history of abusing legal drugs or the use of illegal drugs or substances\n11. History of hypersensitivity or intolerance to aerosol medications\n12. Participation in another investigational drug study where drug was received within 30 days prior to the Screening Visit'}, 'identificationModule': {'nctId': 'NCT02951312', 'briefTitle': 'Assessment of the Safety and Ability of a Once-a-day Dose of an Orally Inhaled Medicine [ie, Glycopyrrolate Inhalation Solution = GIS] to Improve Airflow in the Lungs When Delivered With an Electronic eFlow Nebulizer System in Patients With Chronic Obstructive Pulmonary Disease (COPD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sunovion Respiratory Development Inc.'}, 'officialTitle': 'Single-dose, Dose Escalation Study to Assess the Safety, Tolerability, Pharmacokinetics and Bronchodilatory Effects of Glycopyrrolate Inhalation Solution (GIS) Using a High Efficiency Nebulizer in Patients With COPD', 'orgStudyIdInfo': {'id': 'EP-101-01'}, 'secondaryIdInfos': [{'id': '2009-010821-38', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glycopyrrolate Inhalation Solution 25mg', 'description': 'Glycopyrrolate Inhalation Solution 25 μg via eFlow nebulizer, once daily', 'interventionNames': ['Drug: Glycopyrrolate Inhalation Solution 25mg']}, {'type': 'EXPERIMENTAL', 'label': 'Glycopyrrolate Inhalation Solution 75mg', 'description': 'Glycopyrrolate Inhalation Solution 75 μg via eFlow nebulizer, once daily', 'interventionNames': ['Drug: Glycopyrrolate Inhalation Solution 75mg']}, {'type': 'EXPERIMENTAL', 'label': 'Glycopyrrolate Inhalation Solution 200mg', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via eFlow nebulizer, once daily', 'interventionNames': ['Drug: Glycopyrrolate Inhalation Solution 200mg']}, {'type': 'EXPERIMENTAL', 'label': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'description': 'Glycopyrrolate Inhalation Solution 200 μg via jet nebulizer, once daily', 'interventionNames': ['Drug: Glycopyrrolate Inhalation Solution 200mg Jet']}, {'type': 'EXPERIMENTAL', 'label': 'Glycopyrrolate Inhalation Solution 500mg', 'description': 'Glycopyrrolate Inhalation Solution 500 μg via eFlow nebulizer, once daily', 'interventionNames': ['Drug: Glycopyrrolate Inhalation Solution 500mg']}, {'type': 'EXPERIMENTAL', 'label': 'Glycopyrrolate Inhalation Solution1000mg', 'description': 'Glycopyrrolate Inhalation Solution 1000 μg via eFlow nebulizer, once daily', 'interventionNames': ['Drug: Glycopyrrolate Inhalation Solution1000mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 0.5 mL', 'description': 'Placebo 0.5 mL via jet nebulizer, once daily', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Glycopyrrolate Inhalation Solution 25mg', 'type': 'DRUG', 'otherNames': ['GIS'], 'description': '25 μg oral inhalation via eFlow Nebulizer, once daily', 'armGroupLabels': ['Glycopyrrolate Inhalation Solution 25mg']}, {'name': 'Glycopyrrolate Inhalation Solution 75mg', 'type': 'DRUG', 'otherNames': ['GIS'], 'description': '75 μg oral inhalation via eFlow Nebulizer, once daily', 'armGroupLabels': ['Glycopyrrolate Inhalation Solution 75mg']}, {'name': 'Glycopyrrolate Inhalation Solution 200mg', 'type': 'DRUG', 'otherNames': ['GIS'], 'description': '200 μg oral inhalation via eFlow Nebulizer, once daily', 'armGroupLabels': ['Glycopyrrolate Inhalation Solution 200mg']}, {'name': 'Glycopyrrolate Inhalation Solution 200mg Jet', 'type': 'DRUG', 'otherNames': ['GIS'], 'description': '200 μg oral inhalation via inhalation via jet nebulizer, once daily', 'armGroupLabels': ['Glycopyrrolate Inhalation Solution 200mg Jet']}, {'name': 'Glycopyrrolate Inhalation Solution 500mg', 'type': 'DRUG', 'otherNames': ['GIS'], 'description': '500 μg oral inhalation via eFlow nebulizer, once daily', 'armGroupLabels': ['Glycopyrrolate Inhalation Solution 500mg']}, {'name': 'Glycopyrrolate Inhalation Solution1000mg', 'type': 'DRUG', 'otherNames': ['GIS'], 'description': '1000 μg oral inhalation via eFlow nebulizer, once daily', 'armGroupLabels': ['Glycopyrrolate Inhalation Solution1000mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo 0.5 mL oral inhalation via jet nebulizer, once daily', 'armGroupLabels': ['Placebo 0.5 mL']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Ahmet Tutuncu, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Elevation Pharmaceuticals, Inc.(now known as Sunovion Respiratory Development Inc.)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sunovion Respiratory Development Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}