Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2026-01-04 @ 6:51 PM
Study NCT ID:
NCT02685293
Status:
TERMINATED
Last Update Posted:
2019-08-28
First Post:
2016-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPD
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}], 'ancestors': [{'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'phone': '+1 302 885 1180', 'title': 'Global Clinical Lead', 'organization': 'Pearl Therapeutics Inc.'}, 'certainAgreement': {'otherDetails': "Drafts of any and all publications or presentations of this study must be submitted at least 30 days prior to submission for publication or presentation to Pearl Therapeutics for review, approval, and to ensure consistency. Pearl Therapeutics has the right to request appropriate modification to correct facts and to represent it's opinions, or the opinions of the publication committee, if these differ with the proposed publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated early on 20 June 2018 as target enrollment numbers were not met.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected from screening, throughout the treatment periods until the follow-up visit 14±2 days from the last study treatment administration. Overall timeframe of up to a maximum of 12 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Skin irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Right Ventricular End Diastolic Volume Index (RVEDVi) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.10', 'spread': '7.69', 'groupId': 'OG000'}, {'value': '-7.93', 'spread': '8.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of right ventricular (RV) volume was performed using magnetic resonance imaging (MRI) using RV end diastolic volume (RVEDV), 2-3 hours after dosing on Day 8 of each treatment period. RVEDV was normalized to body surface area (BSA) to provide the indexed counterpart (RVEDVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'unitOfMeasure': 'cm^3/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Aortic Left Ventricular Stroke Volume (LVSV) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.40', 'spread': '14.14', 'groupId': 'OG000'}, {'value': '2.88', 'spread': '12.61', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of LVSV was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Right Ventricular Stroke Volume (RVSV) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.38', 'spread': '12.74', 'groupId': 'OG000'}, {'value': '2.83', 'spread': '12.40', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of RVSV, phase contrast from pulmonic valve, was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'unitOfMeasure': 'cm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulmonary Artery Velocity at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.91', 'spread': '1.67', 'groupId': 'OG000'}, {'value': '-0.15', 'spread': '1.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of Pulmonary Artery Velocity was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'unitOfMeasure': 'cm/second', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.95', 'spread': '6.47', 'groupId': 'OG000'}, {'value': '-1.77', 'spread': '6.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of left ventricular (LV) volume was performed using MRI using LV end diastolic volume (LVEDV), 2-3 hours after dosing of Day 8 of each treatment period. LVEDV was normalized to BSA to provide the indexed counterpart (LVEDVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'unitOfMeasure': 'cm^3/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Cardiac Output at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.95', 'spread': '0.80', 'groupId': 'OG000'}, {'value': '0.38', 'spread': '1.17', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of cardiac output was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'unitOfMeasure': 'Liters/minute', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulmonary Vascular Resistance (PVR) at 30 and 60 Minutes Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of PVR was performed by impedance cardiography at 30 and 60 minutes after dosing on Day 8 of each treatment period. Baseline for was defined as the average of the subject values obtained pre-dose on Day 1 of each treatment period.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data for this endpoint were not collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulmonary Artery/Aortic Diameter Ratio (PA:A) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of PA:A was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'unitOfMeasure': 'ratio', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Atrial End Diastolic Volume (LAEDV) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of LAEDV was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data for this endpoint were not collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Atrial End Systolic Volume (LAESV) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of LAESV was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data for this endpoint were not collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Atrial Ejection Fraction (LAEF) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of LAEF was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'reportingStatus': 'POSTED', 'populationDescription': 'Due to early termination of the study, data for this endpoint were not collected.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVi) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.68', 'spread': '2.56', 'groupId': 'OG000'}, {'value': '-3.18', 'spread': '2.06', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of LV volume was performed using MRI using LV end systolic volume (LVESV), 2-3 hours after dosing on Day 8 of each treatment period. LVESV was normalized to BSA to provide the indexed counterpart (LVESVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'unitOfMeasure': 'cm^3/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Right Ventricular End Systolic Volume Index (RVESVi) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.92', 'spread': '5.95', 'groupId': 'OG000'}, {'value': '-9.23', 'spread': '4.64', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of RV volume was performed using MRI using RV end systolic volume (RVESV), 2-3 hours after dosing on Day 8 of each treatment period. RVESV was normalized to BSA to provide the indexed counterpart (RVESVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'unitOfMeasure': 'cm^3/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulsatility Index Aorta (PIAo) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.63', 'spread': '13.45', 'groupId': 'OG000'}, {'value': '-0.37', 'spread': '4.07', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of PIAo was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Pulmonary Artery Pulsatility Index (PAPi) at 2-3 Hours Post-dose on Day 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'GFF MDI', 'description': 'GFF MDI (PT003) 14.4/9.6 μg was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}, {'id': 'OG001', 'title': 'Placebo MDI', 'description': 'Placebo MDI was administered as 2 inhalations BID for 7 days in either treatment period 1 or treatment period 2.'}], 'classes': [{'categories': [{'measurements': [{'value': '3.60', 'spread': '10.86', 'groupId': 'OG000'}, {'value': '-4.95', 'spread': '19.54', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of PAPi was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.', 'unitOfMeasure': 'percent', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All randomized subjects.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'GFF MDI, Then Placebo MDI', 'description': 'Subjects first received GFF MDI (PT003) 14.4/9.6 micrograms (μg) as 2 inhalations twice daily (BID) for 7 days in treatment period 1. After a washout period, subjects then received Placebo MDI as 2 inhalations BID for 7 days in treatment period 2.'}, {'id': 'FG001', 'title': 'Placebo MDI, Then GFF MDI', 'description': 'Subjects first received Placebo MDI as 2 inhalations BID for 7 days in treatment period 1. After a washout period, subjects then received GFF MDI 14.4/9.6 μg as 2 inhalations BID for 7 days in treatment period 2.'}], 'periods': [{'title': 'Treatment Period 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Washout Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}, {'title': 'Treatment Period 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects with moderate to severe chronic obstructive pulmonary disease (COPD) were enrolled into this 2-period, 2-treatment, crossover study from 09 December 2016. The study was terminated early on 20 June 2018.', 'preAssignmentDetails': 'Subjects were randomly assigned, in a 1:1 ratio, to receive either Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI) then Placebo MDI or Placebo MDI then GFF MDI in two 7-day treatment periods, separated by a washout period of between 7 and 21 days.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Randomized Subjects', 'description': 'All subjects randomized to receive treatment.'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'White', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'More than one race', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': 'Unknown or Not Reported', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-09-26', 'size': 6603384, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-08-12T14:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 4}}, 'statusModule': {'whyStopped': 'Lack of recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2016-12-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-12', 'studyFirstSubmitDate': '2016-01-28', 'resultsFirstSubmitDate': '2019-06-06', 'studyFirstSubmitQcDate': '2016-02-12', 'lastUpdatePostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-08-12', 'studyFirstPostDateStruct': {'date': '2016-02-18', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Right Ventricular End Diastolic Volume Index (RVEDVi) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of right ventricular (RV) volume was performed using magnetic resonance imaging (MRI) using RV end diastolic volume (RVEDV), 2-3 hours after dosing on Day 8 of each treatment period. RVEDV was normalized to body surface area (BSA) to provide the indexed counterpart (RVEDVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Aortic Left Ventricular Stroke Volume (LVSV) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of LVSV was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Right Ventricular Stroke Volume (RVSV) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of RVSV, phase contrast from pulmonic valve, was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Pulmonary Artery Velocity at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of Pulmonary Artery Velocity was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Left Ventricular End Diastolic Volume Index (LVEDVi) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of left ventricular (LV) volume was performed using MRI using LV end diastolic volume (LVEDV), 2-3 hours after dosing of Day 8 of each treatment period. LVEDV was normalized to BSA to provide the indexed counterpart (LVEDVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Cardiac Output at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of cardiac output was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Pulmonary Vascular Resistance (PVR) at 30 and 60 Minutes Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of PVR was performed by impedance cardiography at 30 and 60 minutes after dosing on Day 8 of each treatment period. Baseline for was defined as the average of the subject values obtained pre-dose on Day 1 of each treatment period.'}, {'measure': 'Change From Baseline in Pulmonary Artery/Aortic Diameter Ratio (PA:A) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of PA:A was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Left Atrial End Diastolic Volume (LAEDV) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of LAEDV was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Left Atrial End Systolic Volume (LAESV) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of LAESV was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Left Atrial Ejection Fraction (LAEF) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of LAEF was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Left Ventricular End Systolic Volume Index (LVESVi) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of LV volume was performed using MRI using LV end systolic volume (LVESV), 2-3 hours after dosing on Day 8 of each treatment period. LVESV was normalized to BSA to provide the indexed counterpart (LVESVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Right Ventricular End Systolic Volume Index (RVESVi) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of RV volume was performed using MRI using RV end systolic volume (RVESV), 2-3 hours after dosing on Day 8 of each treatment period. RVESV was normalized to BSA to provide the indexed counterpart (RVESVi). Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Pulsatility Index Aorta (PIAo) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of PIAo was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}, {'measure': 'Change From Baseline in Pulmonary Artery Pulsatility Index (PAPi) at 2-3 Hours Post-dose on Day 8', 'timeFrame': 'Baseline and Day 8 of either treatment period 1 or 2, as applicable.', 'description': 'Assessment of PAPi was performed using MRI, 2-3 hours after dosing on Day 8 of each treatment period. Baseline was defined as the pre-dose value on Day 1 of treatment period 1.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['COPD']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_7111&studyid=4146&filename=PT003017_CSP_V3_Redacted_coverpage_PDFA.pdf', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized, double-blind, placebo-controlled, single-center, chronic-dosing (7 days), two-period, two-treatment, cross-over study to evaluate the treatment effect of PT003 compared with that of Placebo MDI on Cardiovascular Hemodynamics following chronic-dosing (7 days) in subjects with moderate to severe COPD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least 40 years of age and no older than 80 at Visit 1.\n* Women of non-child bearing potential,or negative serum pregnancy test at Screening, and agrees to acceptable contraceptive methods used consistently and correctly from Screening until 14 days after final visit\n* Evidence of lung hyperinflation\n* Subjects with an established clinical history of COPD as defined by the American Thoracic Society (ATS)/European Respiratory Society (ERS)\n* Current or former smokers with a history of at least 10 pack-years of cigarette smoking.\n* Pre- and Post-bronchodilator FEV1/FVC ratio must be \\<0.70\n* Post-bronchodilator FEV1 must be ≥30% to \\<65% predicted normal value, calculated using NHANES III reference equations.\n\nExclusion Criteria:\n\n* Significant diseases or conditions other than COPD which, in the opinion of the Investigator, may put the patient at risk\n* Women who are pregnant or lactating or are planning to become pregnant during the course of the study\n* Subjects, who in the opinion of the Investigator, have a current diagnosis of asthma or other active pulmonary disease\n* Subjects who have been hospitalized due to poorly controlled COPD within 3 months prior to Screening\n* Subjects who have poorly controlled COPD, defined as acute worsening of COPD that requires treatment with oral corticosteroids or antibiotics within 6 weeks prior to Screening or during the Screening Period\n* Subjects who have clinically significant uncontrolled hypertension.\n* Subjects with symptomatic prostatic hypertrophy that is clinically significant and not adequately controlled with appropriate therapy, in the opinion of the Investigator.\n* Subjects with bladder neck obstruction or urinary retention that is clinically significant in the opinion of the Investigator.\n* Subjects with a calculated creatinine clearance ≤30 mL/minute using Chronic Kidney Disease Epidemiology Collaboration. (CKD-EPI) formula at Screening and on repeat testing prior to Visit 2.\n* Subjects with abnormal liver function tests defined as AST, ALT, or total bilirubin ≥ 1.5 times upper limit of normal at Screening and on repeat testing prior to Visit 2\n* Subjects who have cancer that has not been in complete remission for at least five years.\n* Subjects with a diagnosis of glaucoma, who in the opinion of the Investigator, have not been adequately treated.\n* Subjects with a clinically significant ECG\n* Subjects who were previously enrolled in any previous PT001, PT003, or PT005 study conducted or sponsored by Pearl.'}, 'identificationModule': {'nctId': 'NCT02685293', 'briefTitle': 'Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe COPD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pearl Therapeutics, Inc.'}, 'officialTitle': 'A Randomized, Phase IIIb, Two-period , Double-blind, Two-treatment, Chronic-dosing (7 Days), Single-center Crossover Study to Evaluate the Treatment Effect of PT003 on Cardiovascular Hemodynamics in Subjects With Moderate to Severe Chronic Obstructive Pulmonary Disease, Compared With Placebo', 'orgStudyIdInfo': {'id': 'PT003017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GFF MDI (PT003)', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)', 'interventionNames': ['Drug: GFF MDI (PT003)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo MDI', 'description': 'Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol', 'interventionNames': ['Drug: Placebo MDI']}], 'interventions': [{'name': 'GFF MDI (PT003)', 'type': 'DRUG', 'description': 'Glycopyrronium and Formoterol Fumarate Inhalation Aerosol; PT003, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (GFF MDI)', 'armGroupLabels': ['GFF MDI (PT003)']}, {'name': 'Placebo MDI', 'type': 'DRUG', 'description': 'Placebo Metered Dose Inhaler (MDI) for Glycopyrronium and Formoterol Fumarate Inhalation Aerosol', 'armGroupLabels': ['Placebo MDI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Colin Reisner, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pearl Therapeutics'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': "AstraZeneca's policy is to share data with researchers if the request is in scope of our policy. The policy and additional information can be found on astrazenecaclinicaltrials.com."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pearl Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}