Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-25 @ 9:29 PM
Study NCT ID:
NCT01143051
Status:
COMPLETED
Last Update Posted:
2018-09-25
First Post:
2010-06-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004837', 'term': 'Epinephrine'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D015306', 'term': 'Biogenic Monoamines'}, {'id': 'D001679', 'term': 'Biogenic Amines'}, {'id': 'D002395', 'term': 'Catecholamines'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'stephenc@amphastar.com', 'phone': '(909) 980-9484', 'title': 'Stephen A. Campbell, Esq.', 'phoneExt': '2016', 'organization': 'Amphastar Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': 'The PI is to maintain all information, data, inventions and discoveries disclosed by the Sponsor in confidence unless that information was in public domain at time of disclosure or becomes part of the public domain or is published through no fault of the PI or Institution, or was in the possession of the PI or Institution at time of disclosure and was not acquired from Sponsor under any obligation of confidentiality or is produced pursuant to a validly issued subpoena.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All patients were closely monitored for any incidence of adverse events by the investigators during the entire study period.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment T1', 'description': 'T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation\n\nepinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations', 'otherNumAtRisk': 24, 'otherNumAffected': 1, 'seriousNumAtRisk': 24, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment T2', 'description': 'HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation\n\nepinephrine inhalation aerosol : HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations', 'otherNumAtRisk': 23, 'otherNumAffected': 1, 'seriousNumAtRisk': 23, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Treatment C', 'description': 'Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.\n\nepinephrine inhalation aerosol : Single dose 220 mcg/inhalation, 10 inhalations', 'otherNumAtRisk': 22, 'otherNumAffected': 1, 'seriousNumAtRisk': 22, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Upset stomach', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Sore throat', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}, {'term': 'Lightheadedness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 23, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 22, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (15.1)'}], 'frequencyThreshold': '3'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '9.3', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '21.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': '0 to 30 minutes prior to dosing', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.'}, {'type': 'PRIMARY', 'title': 'Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '7938', 'spread': '5023', 'groupId': 'OG000'}, {'value': '9438', 'spread': '4819', 'groupId': 'OG001'}, {'value': '7218', 'spread': '6489', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 6 hours post-dose', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC\\[0-6\\]) was calculated using the trapezoidal rule.', 'unitOfMeasure': 'pg*min/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.'}, {'type': 'PRIMARY', 'title': 'Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '340', 'spread': '294', 'groupId': 'OG000'}, {'value': '444', 'spread': '328', 'groupId': 'OG001'}, {'value': '139', 'spread': '98', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 6 hours post-dose', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Peak Concentration (Tmax) for Total Epinephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '34.6', 'spread': '100.2', 'groupId': 'OG000'}, {'value': '37.0', 'spread': '104.5', 'groupId': 'OG001'}, {'value': '38.0', 'spread': '104.3', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 6 hours post-dose', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.', 'unitOfMeasure': 'min', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least four of the five post-dose PK measurements between 5 and 60 min post-dose available and 4) have a minimum of eight of the ten post-dose PK measurements for the entire 6 hour post-dose PK sampling period.'}, {'type': 'PRIMARY', 'title': 'Half-life (t1/2) for Total Epinephrine', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'categories': [{'measurements': [{'value': '125.9', 'spread': '183.3', 'groupId': 'OG000', 'lowerLimit': '10.8', 'upperLimit': '337.3'}, {'value': '158.8', 'spread': '238.0', 'groupId': 'OG001', 'lowerLimit': '3.1', 'upperLimit': '432.8'}, {'value': '237.3', 'spread': '175.2', 'groupId': 'OG002', 'lowerLimit': '6.8', 'upperLimit': '490.2'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 6 hours post-dose', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period.', 'unitOfMeasure': 'min', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who: 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 min post-dose available; and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period.'}, {'type': 'PRIMARY', 'title': 'Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '22', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten(10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'title': 'Total Epinephrine, 0 min (Baseline)', 'categories': [{'measurements': [{'value': '9.3', 'spread': '17.7', 'groupId': 'OG000'}, {'value': '8.9', 'spread': '15.8', 'groupId': 'OG001'}, {'value': '7.8', 'spread': '21.4', 'groupId': 'OG002'}]}]}, {'title': 'Total Epinephrine, 5 min post-dose', 'categories': [{'measurements': [{'value': '339.6', 'spread': '295.1', 'groupId': 'OG000'}, {'value': '442.4', 'spread': '330.8', 'groupId': 'OG001'}, {'value': '130.2', 'spread': '101.8', 'groupId': 'OG002'}]}]}, {'title': 'Total Epinephrine, 15 min post-dose', 'categories': [{'measurements': [{'value': '48.9', 'spread': '33.7', 'groupId': 'OG000'}, {'value': '62.4', 'spread': '42.5', 'groupId': 'OG001'}, {'value': '38.5', 'spread': '21.2', 'groupId': 'OG002'}]}]}, {'title': 'Total Epinephrine, 30 min post-dose', 'categories': [{'measurements': [{'value': '12.7', 'spread': '18.8', 'groupId': 'OG000'}, {'value': '17.4', 'spread': '18.3', 'groupId': 'OG001'}, {'value': '16.8', 'spread': '17.6', 'groupId': 'OG002'}]}]}, {'title': 'Total Epinephrine, 45 min post-dose', 'categories': [{'measurements': [{'value': '8.6', 'spread': '14.4', 'groupId': 'OG000'}, {'value': '13.0', 'spread': '17.2', 'groupId': 'OG001'}, {'value': '20.9', 'spread': '18.6', 'groupId': 'OG002'}]}]}, {'title': 'Total Epinephrine, 60 min post-dose', 'categories': [{'measurements': [{'value': '7.6', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '14.5', 'spread': '17.3', 'groupId': 'OG001'}, {'value': '18.0', 'spread': '18.6', 'groupId': 'OG002'}]}]}, {'title': 'Total Epinephrine, 90 min post-dose', 'categories': [{'measurements': [{'value': '5.7', 'spread': '11.6', 'groupId': 'OG000'}, {'value': '13.7', 'spread': '14.8', 'groupId': 'OG001'}, {'value': '16.7', 'spread': '16.6', 'groupId': 'OG002'}]}]}, {'title': 'Total Epinephrine, 120 min post-dose', 'categories': [{'measurements': [{'value': '8.7', 'spread': '12.8', 'groupId': 'OG000'}, {'value': '15.5', 'spread': '19.7', 'groupId': 'OG001'}, {'value': '13.1', 'spread': '17.6', 'groupId': 'OG002'}]}]}, {'title': 'Total Epinephrine, 180 min post-dose', 'categories': [{'measurements': [{'value': '12.0', 'spread': '20.2', 'groupId': 'OG000'}, {'value': '10.4', 'spread': '15.2', 'groupId': 'OG001'}, {'value': '8.4', 'spread': '15.2', 'groupId': 'OG002'}]}]}, {'title': 'Total Epinephrine, 240 min post-dose', 'categories': [{'measurements': [{'value': '12.9', 'spread': '20.4', 'groupId': 'OG000'}, {'value': '11.5', 'spread': '14.9', 'groupId': 'OG001'}, {'value': '9.8', 'spread': '18.1', 'groupId': 'OG002'}]}]}, {'title': 'Total Epinephrine, 360 min post-dose', 'categories': [{'measurements': [{'value': '31.1', 'spread': '24.0', 'groupId': 'OG000'}, {'value': '29.4', 'spread': '23.0', 'groupId': 'OG001'}, {'value': '38.3', 'spread': '40.8', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose to 6 hours post-dose', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients who : 1) have taken the valid pre-dose baseline PK sample 2) have correctly taken the randomized study-drug treatment 3) have at least 4 of the 5 post-dose PK measurements between 5 and 60 minutes post-dose available and 4) have a min of 8 of the 10 post-dose PK measurements for the entire 6 hour post-dose PK sampling period.'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Systolic Blood Pressure (SBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'title': 'Pre-dose (Baseline)', 'categories': [{'measurements': [{'value': '110', 'spread': '10.0', 'groupId': 'OG000'}, {'value': '112', 'spread': '13.2', 'groupId': 'OG001'}, {'value': '111', 'spread': '9.4', 'groupId': 'OG002'}]}]}, {'title': '10 min post-dose', 'categories': [{'measurements': [{'value': '123', 'spread': '13.8', 'groupId': 'OG000'}, {'value': '122', 'spread': '14.1', 'groupId': 'OG001'}, {'value': '121', 'spread': '11.3', 'groupId': 'OG002'}]}]}, {'title': '30 min post-dose', 'categories': [{'measurements': [{'value': '116', 'spread': '12.3', 'groupId': 'OG000'}, {'value': '117', 'spread': '11.5', 'groupId': 'OG001'}, {'value': '116', 'spread': '10.6', 'groupId': 'OG002'}]}]}, {'title': '60 min post-dose', 'categories': [{'measurements': [{'value': '113', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '113', 'spread': '9.9', 'groupId': 'OG001'}, {'value': '115', 'spread': '10.0', 'groupId': 'OG002'}]}]}, {'title': '120 min post-dose', 'categories': [{'measurements': [{'value': '112', 'spread': '10.4', 'groupId': 'OG000'}, {'value': '114', 'spread': '9.6', 'groupId': 'OG001'}, {'value': '114', 'spread': '10.9', 'groupId': 'OG002'}]}]}, {'title': '180 min post-dose', 'categories': [{'measurements': [{'value': '114', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '113', 'spread': '11.4', 'groupId': 'OG001'}, {'value': '115', 'spread': '11.0', 'groupId': 'OG002'}]}]}, {'title': '360 min post-dose', 'categories': [{'measurements': [{'value': '113', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '113', 'spread': '9.3', 'groupId': 'OG001'}, {'value': '113', 'spread': '9.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who have taken any amount of study drug treatment.'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Diastolic Blood Pressure (DBP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'title': 'Pre-dose (Baseline)', 'categories': [{'measurements': [{'value': '62', 'spread': '9.3', 'groupId': 'OG000'}, {'value': '61', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '61', 'spread': '10.8', 'groupId': 'OG002'}]}]}, {'title': '10 min post-dose', 'categories': [{'measurements': [{'value': '63', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '64', 'spread': '10.0', 'groupId': 'OG001'}, {'value': '65', 'spread': '10.2', 'groupId': 'OG002'}]}]}, {'title': '30 min post-dose', 'categories': [{'measurements': [{'value': '64', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '64', 'spread': '9.2', 'groupId': 'OG001'}, {'value': '65', 'spread': '9.5', 'groupId': 'OG002'}]}]}, {'title': '60 min post-dose', 'categories': [{'measurements': [{'value': '63', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '64', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '63', 'spread': '8.8', 'groupId': 'OG002'}]}]}, {'title': '120 min post-dose', 'categories': [{'measurements': [{'value': '61', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '63', 'spread': '11.9', 'groupId': 'OG001'}, {'value': '62', 'spread': '10.6', 'groupId': 'OG002'}]}]}, {'title': '180 min post-dose', 'categories': [{'measurements': [{'value': '62', 'spread': '8.3', 'groupId': 'OG000'}, {'value': '60', 'spread': '9.5', 'groupId': 'OG001'}, {'value': '59', 'spread': '7.5', 'groupId': 'OG002'}]}]}, {'title': '360 min post-dose', 'categories': [{'measurements': [{'value': '62', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '62', 'spread': '10.1', 'groupId': 'OG001'}, {'value': '62', 'spread': '8.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who have taken any amount of study drug treatment.'}, {'type': 'SECONDARY', 'title': 'Vital Signs: Heart Rate (HR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'title': 'Pre-dose (Baseline)', 'categories': [{'measurements': [{'value': '60', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '62', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '58', 'spread': '11.7', 'groupId': 'OG002'}]}]}, {'title': '10 min post-dose', 'categories': [{'measurements': [{'value': '67', 'spread': '14.0', 'groupId': 'OG000'}, {'value': '69', 'spread': '12.2', 'groupId': 'OG001'}, {'value': '62', 'spread': '12.7', 'groupId': 'OG002'}]}]}, {'title': '30 min post-dose', 'categories': [{'measurements': [{'value': '63', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '64', 'spread': '9.8', 'groupId': 'OG001'}, {'value': '61', 'spread': '13.7', 'groupId': 'OG002'}]}]}, {'title': '60 min post-dose', 'categories': [{'measurements': [{'value': '67', 'spread': '12.9', 'groupId': 'OG000'}, {'value': '67', 'spread': '14.4', 'groupId': 'OG001'}, {'value': '61', 'spread': '10.8', 'groupId': 'OG002'}]}]}, {'title': '120 min post-dose', 'categories': [{'measurements': [{'value': '60', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '60', 'spread': '7.1', 'groupId': 'OG001'}, {'value': '58', 'spread': '9.4', 'groupId': 'OG002'}]}]}, {'title': '180 min post-dose', 'categories': [{'measurements': [{'value': '66', 'spread': '11.1', 'groupId': 'OG000'}, {'value': '66', 'spread': '10.5', 'groupId': 'OG001'}, {'value': '63', 'spread': '9.9', 'groupId': 'OG002'}]}]}, {'title': '360 min post-dose', 'categories': [{'measurements': [{'value': '64', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '64', 'spread': '10.4', 'groupId': 'OG001'}, {'value': '61', 'spread': '8.4', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.', 'unitOfMeasure': 'beats per minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who have taken any amount of study drug treatment.'}, {'type': 'SECONDARY', 'title': 'ECG: QT Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'title': 'Pre-dose (Baseline)', 'categories': [{'measurements': [{'value': '416', 'spread': '33.6', 'groupId': 'OG000'}, {'value': '407', 'spread': '30.1', 'groupId': 'OG001'}, {'value': '423', 'spread': '44.1', 'groupId': 'OG002'}]}]}, {'title': '30 min post-dose', 'categories': [{'measurements': [{'value': '404', 'spread': '38.6', 'groupId': 'OG000'}, {'value': '405', 'spread': '32.8', 'groupId': 'OG001'}, {'value': '413', 'spread': '44.8', 'groupId': 'OG002'}]}]}, {'title': '90 min post-dose', 'categories': [{'measurements': [{'value': '399', 'spread': '34.3', 'groupId': 'OG000'}, {'value': '401', 'spread': '32.9', 'groupId': 'OG001'}, {'value': '407', 'spread': '41.3', 'groupId': 'OG002'}]}]}, {'title': '360 min post-dose', 'categories': [{'measurements': [{'value': '399', 'spread': '41.5', 'groupId': 'OG000'}, {'value': '400', 'spread': '33.1', 'groupId': 'OG001'}, {'value': '400', 'spread': '37.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who have taken any amount of study drug treatment.'}, {'type': 'SECONDARY', 'title': 'ECG: QTc Interval', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'title': 'Pre-dose (Baseline)', 'categories': [{'measurements': [{'value': '407', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '407', 'spread': '20.0', 'groupId': 'OG001'}, {'value': '403', 'spread': '16.2', 'groupId': 'OG002'}]}]}, {'title': '30 min post-dose', 'categories': [{'measurements': [{'value': '408', 'spread': '15.2', 'groupId': 'OG000'}, {'value': '411', 'spread': '19.4', 'groupId': 'OG001'}, {'value': '412', 'spread': '22.3', 'groupId': 'OG002'}]}]}, {'title': '90 min post-dose', 'categories': [{'measurements': [{'value': '401', 'spread': '16.9', 'groupId': 'OG000'}, {'value': '401', 'spread': '18.1', 'groupId': 'OG001'}, {'value': '403', 'spread': '14.1', 'groupId': 'OG002'}]}]}, {'title': '360 min post-dose', 'categories': [{'measurements': [{'value': '403', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '403', 'spread': '17.9', 'groupId': 'OG001'}, {'value': '402', 'spread': '15.7', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.', 'unitOfMeasure': 'msec', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who have taken any amount of study drug treatment.'}, {'type': 'SECONDARY', 'title': 'Serum Glucose Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'title': 'Pre-dose (Baseline)', 'categories': [{'measurements': [{'value': '83', 'spread': '6.9', 'groupId': 'OG000'}, {'value': '83', 'spread': '9.1', 'groupId': 'OG001'}, {'value': '84', 'spread': '6.2', 'groupId': 'OG002'}]}]}, {'title': '15 min post-dose', 'categories': [{'measurements': [{'value': '101', 'spread': '17.0', 'groupId': 'OG000'}, {'value': '105', 'spread': '11.6', 'groupId': 'OG001'}, {'value': '96', 'spread': '11.0', 'groupId': 'OG002'}]}]}, {'title': '30 min post-dose', 'categories': [{'measurements': [{'value': '94', 'spread': '16.4', 'groupId': 'OG000'}, {'value': '99', 'spread': '12.1', 'groupId': 'OG001'}, {'value': '98', 'spread': '10.7', 'groupId': 'OG002'}]}]}, {'title': '60 min post-dose', 'categories': [{'measurements': [{'value': '86', 'spread': '8.9', 'groupId': 'OG000'}, {'value': '86', 'spread': '10.8', 'groupId': 'OG001'}, {'value': '94', 'spread': '12.5', 'groupId': 'OG002'}]}]}, {'title': '120 min post-dose', 'categories': [{'measurements': [{'value': '81', 'spread': '6.8', 'groupId': 'OG000'}, {'value': '82', 'spread': '6.1', 'groupId': 'OG001'}, {'value': '83', 'spread': '5.3', 'groupId': 'OG002'}]}]}, {'title': '360 min post-dose', 'categories': [{'measurements': [{'value': '82', 'spread': '7.9', 'groupId': 'OG000'}, {'value': '82', 'spread': '9.4', 'groupId': 'OG001'}, {'value': '80', 'spread': '7.1', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose.', 'unitOfMeasure': 'mg/dL', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who have taken any amount of study drug treatment.'}, {'type': 'SECONDARY', 'title': 'Serum Potassium Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'title': 'Pre-dose (Baseline)', 'categories': [{'measurements': [{'value': '4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '4', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': '15 min post-dose', 'categories': [{'measurements': [{'value': '4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4', 'spread': '0.3', 'groupId': 'OG002'}]}]}, {'title': '30 min post-dose', 'categories': [{'measurements': [{'value': '4', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '4', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4', 'spread': '0.3', 'groupId': 'OG002'}]}]}, {'title': '60 min post-dose', 'categories': [{'measurements': [{'value': '4', 'spread': '0.2', 'groupId': 'OG000'}, {'value': '4', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': '120 min post-dose', 'categories': [{'measurements': [{'value': '4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4', 'spread': '0.3', 'groupId': 'OG002'}]}]}, {'title': '360 min post-dose', 'categories': [{'measurements': [{'value': '4', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '4', 'spread': '0.3', 'groupId': 'OG001'}, {'value': '4', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who have taken any amount of study drug treatment.'}, {'type': 'SECONDARY', 'title': 'Hand Tremor Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}, {'value': '23', 'groupId': 'OG001'}, {'value': '22', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment T1', 'description': 'Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine'}, {'id': 'OG001', 'title': 'Treatment T2', 'description': 'Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine'}, {'id': 'OG002', 'title': 'Treatment C', 'description': 'Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine'}], 'classes': [{'title': 'Pre-dose (Baseline)', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG002'}]}]}, {'title': '10 min post-dose', 'categories': [{'measurements': [{'value': '0.1', 'spread': '0.3', 'groupId': 'OG000'}, {'value': '0.2', 'spread': '0.4', 'groupId': 'OG001'}, {'value': '0.1', 'spread': '0.4', 'groupId': 'OG002'}]}]}, {'title': '60 min post-dose', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG002'}]}]}, {'title': '360 min post-dose', 'categories': [{'measurements': [{'value': '0.0', 'spread': '0.0', 'groupId': 'OG000'}, {'value': '0.0', 'spread': '0.0', 'groupId': 'OG001'}, {'value': '0.0', 'spread': '0.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subjects evaluated hand tremor experiences using a scale from 0 to 3 (0: No tremor; 1: Mild, perceivable; 2: Moderate, observable; and 3: Severe, interfering with hand activities). Hand tremors were evaluated prior to study drug dosing (baseline) and up to 360 minutes post-dose.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who have taken any amount of study drug treatment.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Significant Changes in Physical Examination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Subjects', 'description': 'Subjects who have taken any amount of study drug treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 6 weeks', 'description': 'Physical examinations were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS physical examination compared to the Screening Visit.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who have taken any amount of study drug treatment. The Arm/Group is presented as one group because subjects would have received all 3 different study drug treatments prior to EOS due to the crossover study design.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Significant Changes in Laboratory Tests', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized Subjects', 'description': 'Subjects who have taken any amount of study drug treatment.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Approximately 6 weeks', 'description': 'Laboratory tests (CBC, serum comprehensive metabolic panel, urinalysis, and urinary pregnancy test for women of childbearing potential) were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS laboratory tests compared to the Screening Visit.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects who have taken any amount of study drug treatment. The Arm/Group is presented as one group because subjects would have received all 3 different study drug treatments prior to EOS due to the crossover study design.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'C, T1, T2', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.'}, {'id': 'FG001', 'title': 'C, T2, T1', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.'}, {'id': 'FG002', 'title': 'T1, C, T2', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.'}, {'id': 'FG003', 'title': 'T1, T2, C', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.'}, {'id': 'FG004', 'title': 'T2, C, T1', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.'}, {'id': 'FG005', 'title': 'T2, T1, C', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.'}], 'periods': [{'title': 'Visit 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': '3-14 Day Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Visit 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': '3-14 Day Washout', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}]}]}, {'title': 'Visit 3', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '3'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from a specialty clinic in Cypress, CA between 04/29/2010 and 05/27/2010', 'preAssignmentDetails': 'A total of 38 subjects were screened, 24 subjects passed screening, consented and were randomized for participation in the study. The IRB approval date was 04/29/2010, the last subject was screened on 05/27/2010.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'C, T1, T2', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.'}, {'id': 'BG001', 'title': 'C, T2, T1', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.'}, {'id': 'BG002', 'title': 'T1, C, T2', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min.'}, {'id': 'BG003', 'title': 'T1, T2, C', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 2: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 3: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.'}, {'id': 'BG004', 'title': 'T2, C, T1', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min; Visit 3: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min.'}, {'id': 'BG005', 'title': 'T2, T1, C', 'description': 'Subjects received one of the three treatments during each study visit, separated by a washout period of 3-14 days. Visit 1: Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine, in 5 min; Visit 2: Treatment T1: Ten (10) inhalations of the low dose E004 (125 mcg/inhalation), totaling 1.25 mg of epinephrine, in 5 min; Visit 3 Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation), totaling 2.20 mg of epinephrine, in 5 min.'}, {'id': 'BG006', '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': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.0', 'spread': '2.94', 'groupId': 'BG000'}, {'value': '25.3', 'spread': '4.27', 'groupId': 'BG001'}, {'value': '24.0', 'spread': '3.37', 'groupId': 'BG002'}, {'value': '21.8', 'spread': '1.71', 'groupId': 'BG003'}, {'value': '25.3', 'spread': '0.50', 'groupId': 'BG004'}, {'value': '22.0', 'spread': '3.56', 'groupId': 'BG005'}, {'value': '23.7', 'spread': '3.01', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '9', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-20', 'studyFirstSubmitDate': '2010-06-07', 'resultsFirstSubmitDate': '2014-02-05', 'studyFirstSubmitQcDate': '2010-06-11', 'lastUpdatePostDateStruct': {'date': '2018-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-06-13', 'studyFirstPostDateStruct': {'date': '2010-06-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Baseline Concentration (C0) of Labeled Epinephrine Total Epinephrine', 'timeFrame': '0 to 30 minutes prior to dosing', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at Baseline (prior to dosing) in each treatment period following a specified washout period (3-14 days), and were analyzed using an established analysis method. Baseline concentration (C0) is the concentration of epinephrine measured in the plasma at this time point.'}, {'measure': 'Area Under the Curve From Time Zero to 6 Hours Post-dose (AUC[0-6])', 'timeFrame': 'Pre-dose to 6 hours post-dose', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Area under the curve from time zero to 6 hours post-dose (AUC\\[0-6\\]) was calculated using the trapezoidal rule.'}, {'measure': 'Peak Concentration (Cmax) for Total Epinephrine From Time Zero to 6 Hours Post-dose', 'timeFrame': 'Pre-dose to 6 hours post-dose', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Peak (maximum) concentration (Cmax) is the highest concentration of epinephrine measured in plasma during the treatment period.'}, {'measure': 'Time to Reach Peak Concentration (Tmax) for Total Epinephrine', 'timeFrame': 'Pre-dose to 6 hours post-dose', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. tmax is the amount of time it takes for epinephrine to reach peak concentration in plasma during the treatment period.'}, {'measure': 'Half-life (t1/2) for Total Epinephrine', 'timeFrame': 'Pre-dose to 6 hours post-dose', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method. Half-life (t1/2) is the amount of time it takes for epinephrine decrease to half the peak concentration in plasma during the treatment period.'}, {'measure': 'Concentration vs. Time for Total Epinephrine From Time Zero to 6 Hours Post-dose', 'timeFrame': 'Pre-dose to 6 hours post-dose', 'description': 'Patient PK blood samples were taken from a vein in a hand or arm via indwelling heparin-anticoagulated IV catheters, or by venipunctures at 0 (baseline), 5, 15, 30, 45, 60, 90, 120, 180, 240, and 360 minutes post-dose in each treatment period and were analyzed using an established analysis method.'}], 'secondaryOutcomes': [{'measure': 'Vital Signs: Systolic Blood Pressure (SBP)', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.'}, {'measure': 'Vital Signs: Diastolic Blood Pressure (DBP)', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.'}, {'measure': 'Vital Signs: Heart Rate (HR)', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subject vital signs, i.e., blood pressure and heart rate, were measured prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.'}, {'measure': 'ECG: QT Interval', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.'}, {'measure': 'ECG: QTc Interval', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subject QT and QTc Intervals were recorded using a 12-Lead ECG prior to study drug dosing (baseline) and up to 360 minutes after dosing during the study visit.'}, {'measure': 'Serum Glucose Levels', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose.'}, {'measure': 'Serum Potassium Levels', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Blood samples used to measure subject serum glucose and potassium levels were collected prior to study drug dosing (baseline) and up to 360 minutes post-dose.'}, {'measure': 'Hand Tremor Scores', 'timeFrame': 'Pre-dose (baseline) to 360 minutes post-dose', 'description': 'Subjects evaluated hand tremor experiences using a scale from 0 to 3 (0: No tremor; 1: Mild, perceivable; 2: Moderate, observable; and 3: Severe, interfering with hand activities). Hand tremors were evaluated prior to study drug dosing (baseline) and up to 360 minutes post-dose.'}, {'measure': 'Number of Subjects With Significant Changes in Physical Examination', 'timeFrame': 'Approximately 6 weeks', 'description': 'Physical examinations were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS physical examination compared to the Screening Visit.'}, {'measure': 'Number of Subjects With Significant Changes in Laboratory Tests', 'timeFrame': 'Approximately 6 weeks', 'description': 'Laboratory tests (CBC, serum comprehensive metabolic panel, urinalysis, and urinary pregnancy test for women of childbearing potential) were performed as a part of Screening and End-of-Study (EOS) procedures. This outcome is a count of the number of subjects that showed a clinically significant change in the EOS laboratory tests compared to the Screening Visit.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Asthma', 'Pharmacokinetics', 'Epinephrine', 'Bronchodilator', 'metered dose inhaler'], 'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': "This study examines the pharmacokinetic profile of Armstrong's proposed Epinephrine Inhalation Aerosol USP, an HFA-MDI (E004), in healthy male and female adult volunteers. Safety of E004 will also be evaluated, under augmented dose conditions.", 'detailedDescription': 'This study is a randomized, evaluator-blind, single dose, three-arm, crossover, PK study, to be conducted in \\~18 healthy, male and female, adult volunteers. PK will be studied at two dose strengths (Arm T1 and Arm T2). A currently marketed, non-labeled, Epinephrine CFC-MDI will be used as a Reference Control (Arm C).\n\n* At the Screening Visit and the beginning of each Study Visit, each subject will be trained on the correct self-administration of MDI. The following three randomized treatments will be self-administered, at three Study Visits:\n\n * Treatment T1: Ten (10) inhalations of the low dose E004(125 mcg/inhalation), totaling 1.25 mg of epinephrine;\n * Treatment T2: Ten (10) inhalations of the high dose E004 (160 mcg/inhalation), totaling 1.60 mg of epinephrine;\n * Treatment C: Ten (10) inhalations of Epinephrine CFC-MDI (220 mcg/inhalation, totaling 2.2 mg of epinephrine base equivalent).\n* PK blood samples will be taken from a vein at scheduled time points.\n* Safety parameters and adverse drug events, if any, will be monitored and documented at each study visit. An End-of-Study (EOS) safety evaluation will be conducted.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '30 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Generally healthy, male and female adults, 18-30 yrs of age at Screening;\n* Having no clinically significant respiratory, cardiovascular and other systemic or organic illnesses, per investigator discretion;\n* Women of child-bearing potential must be non-pregnant, non-lactating, and practicing a clinically acceptable form of birth control;\n* Having properly consented and satisfied all other inclusion/exclusion criteria as required for this protocol.\n* Other criteria apply.\n\nExclusion Criteria:\n\n* A recent or significant smoking history;\n* Use of prohibited drugs or failure to observe the drug washout restrictions;\n* Having been on other investigational drug/device studies in the last 30 days prior to Screening.\n* Other criteria apply'}, 'identificationModule': {'nctId': 'NCT01143051', 'briefTitle': 'Pharmacokinetics (PK) Study of Epinephrine Inhalation Aerosol in Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Amphastar Pharmaceuticals, Inc.'}, 'officialTitle': 'Phase I/II Study Epinephrine Inhalation Aerosol USP, an HFA-MDI Clinical Study-B for Assessment of Pharmacokinetics', 'orgStudyIdInfo': {'id': 'API-E004-CL-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment C', 'description': 'Active comparator arm utilizing marketed Primatene Mist with CFC propellant at the labeled dose.', 'interventionNames': ['Drug: epinephrine inhalation aerosol']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment 1', 'description': 'T1 is HFA propelled epinephrine inhalation aerosol 125 mcg/inhalation', 'interventionNames': ['Drug: epinephrine inhalation aerosol']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment 2', 'description': 'HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation', 'interventionNames': ['Drug: epinephrine inhalation aerosol']}], 'interventions': [{'name': 'epinephrine inhalation aerosol', 'type': 'DRUG', 'otherNames': ['Primatene Mist'], 'description': 'Single dose 220 mcg/inhalation, 10 inhalations', 'armGroupLabels': ['Treatment C']}, {'name': 'epinephrine inhalation aerosol', 'type': 'DRUG', 'otherNames': ['Primatene Mist'], 'description': 'HFA propelled epinephrine inhalation aerosol, 125 mcg/inhalation, 10 inhalations', 'armGroupLabels': ['Treatment 1']}, {'name': 'epinephrine inhalation aerosol', 'type': 'DRUG', 'otherNames': ['Primatene Mist'], 'description': 'HFA propelled epinephrine inhalation aerosol, 160 mcg/inhalation, 10 inhalations', 'armGroupLabels': ['Treatment 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'Amphastar Location 1', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amphastar Pharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Amphastar Pharmaceuticals, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}