Ignite Creation Date:
2025-12-24 @ 2:17 PM
Ignite Modification Date:
2026-02-03 @ 1:13 PM
Study NCT ID:
NCT02370095
Status:
TERMINATED
Last Update Posted:
2019-10-01
First Post:
2015-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Treprostinil Sodium Inhalation for Patients At High Risk for ARDS
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D055370', 'term': 'Lung Injury'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C427248', 'term': 'treprostinil'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wayne_anderson@med.unc.edu', 'phone': '919-445-0351', 'title': 'Wayne H Anderson, PhD', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The study was stopped because of low recruitment. The limited number of subjects make it difficult to draw conclusions regarding the efficacy of Treprostinil in subjects at high risk of developing ARDS.'}}, 'adverseEventsModule': {'timeFrame': 'From time of enrollment until end of follow-up, approximately 28 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 6, 'seriousNumAtRisk': 10, 'deathsNumAffected': 4, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nausea/Emesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cholelithiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Metapneumovirus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Pneumomediatinum/Bilateral pneumothoraces', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Retro-peritoneal hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematemesis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ileus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Renal Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Sleep Interference', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hematuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Wheezing', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute Kidney Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypernatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transfusion Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'GI Bleed', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Elevated Transaminase', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Parapneuomonic Effusion with decortication', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Delirium', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hyperbilirubinemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 4, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transfusion Reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in the Ratio of the Partial Pressure of Arterial Oxygen to the Fraction of Inspired Oxygen (PaO2/FiO2 Ratio)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'classes': [{'categories': [{'measurements': [{'value': '55.6', 'spread': '31.2', 'groupId': 'OG000'}, {'value': '161.1', 'spread': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2416', 'groupIds': ['OG000', 'OG001'], 'groupDescription': 'Only one placebo subject had data to allow for change from baseline to be calculated', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Change in PaO2/FiO2 ratio from day 0 to day 2.', 'description': 'PaO2/FiO2 ratio', 'unitOfMeasure': 'P/F ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Determination of this endpoint was dependent on subject consent for collection of an arterial blood sample. A baseline measure was obtained from thirteen subjects. Samples were obtained from seven subjects at day 2, and two subjects at day 7 and none at day 28. Analysis was limited to change from baseline to day 2.'}, {'type': 'SECONDARY', 'title': 'Change in the Ratio of Peripheral Oxygen Saturation to Fraction of Inspired Oxygen (SaO2/FiO2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'classes': [{'categories': [{'measurements': [{'value': '303.7', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '382.3', 'spread': '36.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'The change in S/F ratio over time was evaluated using a mixed model for repeated measures'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': '0-12 days', 'description': 'SaO2/FiO2', 'unitOfMeasure': 'S/F ratio', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Number of Days Not on a Ventilator', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'classes': [{'categories': [{'measurements': [{'value': '16.4', 'spread': '14.1', 'groupId': 'OG000'}, {'value': '28', 'spread': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0679', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': '0-28 days post enrollment', 'description': 'Ventilator-free days', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Who Required Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) Via Face Mask', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-28 days', 'description': 'BiPAP / CPAP', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Acute Respiratory Distress Syndrome (ARDS) Associated Biomarkers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'timeFrame': 'Change from day 0 on days 3 and 7', 'description': 'Change in ARDS associated plasma biomarkers', 'reportingStatus': 'POSTED', 'populationDescription': 'Too few samples were collected at the designated days 3 and 7 to provide informative data. Plasma samples were not analyzed.'}, {'type': 'SECONDARY', 'title': 'Change in the Central Venous Oxygen Saturation (SCVO2).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'timeFrame': 'Change in SCVO2 from Day 0 to 3 (if central venous catheter in place)', 'description': 'SCVO2', 'reportingStatus': 'POSTED', 'populationDescription': 'None of the patients had a central venous line, so no samples were obtained for analysis.'}, {'type': 'SECONDARY', 'title': 'Change in Central Venous Pressure (CVP).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'timeFrame': 'Change in CVP from Day 0 to 3 (if central venous catheter in place)', 'description': 'CVP', 'reportingStatus': 'POSTED', 'populationDescription': 'A central venous line was not in place for the subjects so measurements could not be obtained'}, {'type': 'SECONDARY', 'title': 'Change in Mean Arterial Pressure (MAP).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.96', 'spread': '15.5', 'groupId': 'OG000'}, {'value': '8.18', 'spread': '13.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.567', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Measurement of MAP were evaluated from baseline to end of treatment'}], 'paramType': 'MEAN', 'timeFrame': 'Change in MAP from Day 0 to day 7', 'description': 'MAP', 'unitOfMeasure': 'mm Hg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'All-cause Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2507', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'The threshold for statistical significance was 0.05', 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-28 days', 'description': 'All-cause mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Subjects Requiring Intubation and Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '0-28 days', 'description': 'Intubation / Mechanical Ventilation', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat'}, {'type': 'SECONDARY', 'title': 'Number of Deaths During Hospitalization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.5055', 'groupIds': ['OG000'], 'statisticalMethod': 'Fisher Exact', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Deaths during hospitalization (up to 3 months)', 'description': 'Hospital Mortality', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}, {'type': 'SECONDARY', 'title': 'Peak Plasma Concentration Determined 15 Min After Inhalation and Trough Determined 4 Hours Following the Drug/Placebo Administration', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'timeFrame': 'Day 3', 'description': 'Treprostinil Plasma Concentration', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 3 plasma pharmacokinetic samples were collected from subjects treated with Treprostinil and therefore no measurements of plasma Treprostinil were made.'}, {'type': 'SECONDARY', 'title': 'Number of Days From Study Enrollment Until Mechanical Ventilation is Required', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'classes': [{'categories': [{'measurements': [{'value': '2.8', 'spread': '2.2', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Day 0 to day 28', 'description': 'Time to intubation and mechanical ventilation', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to Treat'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'One patient was consented, randomized (Placebo) and baseline data was collected. However, before receiving treatment the subject deteriorated, and a protocol defined stopping rule was met. The subject was defined as completed. Baseline data were used in the analyses, and the AEs recorded are presented in the AE section.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treprostinil Inhalation Solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.\n\nTreprostinil Inhalation Solution: Treprostinil inhalation solution administered as blinded marketed product'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm\n\nPlacebo: Supplied by the manufacturer and similar to the active drug but containing no Treprostinil'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.2', 'spread': '13.1', 'groupId': 'BG000'}, {'value': '51.8', 'spread': '7.6', 'groupId': 'BG001'}, {'value': '50.0', 'spread': '11.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}, {'title': 'African-American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All subjects who signed a consent are included in baseline measurements'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-09', 'size': 985877, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-30T12:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2017-11-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-12', 'studyFirstSubmitDate': '2015-01-30', 'resultsFirstSubmitDate': '2019-08-09', 'studyFirstSubmitQcDate': '2015-02-17', 'lastUpdatePostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-12', 'studyFirstPostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the Ratio of the Partial Pressure of Arterial Oxygen to the Fraction of Inspired Oxygen (PaO2/FiO2 Ratio)', 'timeFrame': 'Change in PaO2/FiO2 ratio from day 0 to day 2.', 'description': 'PaO2/FiO2 ratio'}], 'secondaryOutcomes': [{'measure': 'Change in the Ratio of Peripheral Oxygen Saturation to Fraction of Inspired Oxygen (SaO2/FiO2)', 'timeFrame': '0-12 days', 'description': 'SaO2/FiO2'}, {'measure': 'Number of Days Not on a Ventilator', 'timeFrame': '0-28 days post enrollment', 'description': 'Ventilator-free days'}, {'measure': 'Number of Subjects Who Required Bi-level Positive Airway Pressure (BiPAP) or Continuous Positive Airway Pressure (CPAP) Via Face Mask', 'timeFrame': '0-28 days', 'description': 'BiPAP / CPAP'}, {'measure': 'Acute Respiratory Distress Syndrome (ARDS) Associated Biomarkers', 'timeFrame': 'Change from day 0 on days 3 and 7', 'description': 'Change in ARDS associated plasma biomarkers'}, {'measure': 'Change in the Central Venous Oxygen Saturation (SCVO2).', 'timeFrame': 'Change in SCVO2 from Day 0 to 3 (if central venous catheter in place)', 'description': 'SCVO2'}, {'measure': 'Change in Central Venous Pressure (CVP).', 'timeFrame': 'Change in CVP from Day 0 to 3 (if central venous catheter in place)', 'description': 'CVP'}, {'measure': 'Change in Mean Arterial Pressure (MAP).', 'timeFrame': 'Change in MAP from Day 0 to day 7', 'description': 'MAP'}, {'measure': 'All-cause Mortality', 'timeFrame': '0-28 days', 'description': 'All-cause mortality'}, {'measure': 'Number of Subjects Requiring Intubation and Mechanical Ventilation', 'timeFrame': '0-28 days', 'description': 'Intubation / Mechanical Ventilation'}, {'measure': 'Number of Deaths During Hospitalization', 'timeFrame': 'Deaths during hospitalization (up to 3 months)', 'description': 'Hospital Mortality'}, {'measure': 'Peak Plasma Concentration Determined 15 Min After Inhalation and Trough Determined 4 Hours Following the Drug/Placebo Administration', 'timeFrame': 'Day 3', 'description': 'Treprostinil Plasma Concentration'}, {'measure': 'Number of Days From Study Enrollment Until Mechanical Ventilation is Required', 'timeFrame': 'Day 0 to day 28', 'description': 'Time to intubation and mechanical ventilation'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['ARDS', 'Acute Lung Injury', 'Acute Respiratory Failure'], 'conditions': ['Respiratory Distress Syndrome, Adult']}, 'referencesModule': {'references': [{'pmid': '8970353', 'type': 'BACKGROUND', 'citation': 'Zwissler B, Kemming G, Habler O, Kleen M, Merkel M, Haller M, Briegel J, Welte M, Peter K. Inhaled prostacyclin (PGI2) versus inhaled nitric oxide in adult respiratory distress syndrome. Am J Respir Crit Care Med. 1996 Dec;154(6 Pt 1):1671-7. doi: 10.1164/ajrccm.154.6.8970353.'}, {'pmid': '8630585', 'type': 'BACKGROUND', 'citation': 'Walmrath D, Schneider T, Schermuly R, Olschewski H, Grimminger F, Seeger W. Direct comparison of inhaled nitric oxide and aerosolized prostacyclin in acute respiratory distress syndrome. Am J Respir Crit Care Med. 1996 Mar;153(3):991-6. doi: 10.1164/ajrccm.153.3.8630585.'}, {'pmid': '7881662', 'type': 'BACKGROUND', 'citation': 'Walmrath D, Schneider T, Pilch J, Schermuly R, Grimminger F, Seeger W. Effects of aerosolized prostacyclin in severe pneumonia. Impact of fibrosis. Am J Respir Crit Care Med. 1995 Mar;151(3 Pt 1):724-30. doi: 10.1164/ajrccm.151.3.7881662.'}, {'pmid': '11176161', 'type': 'BACKGROUND', 'citation': 'Domenighetti G, Stricker H, Waldispuehl B. Nebulized prostacyclin (PGI2) in acute respiratory distress syndrome: impact of primary (pulmonary injury) and secondary (extrapulmonary injury) disease on gas exchange response. Crit Care Med. 2001 Jan;29(1):57-62. doi: 10.1097/00003246-200101000-00015.'}, {'pmid': '15071401', 'type': 'BACKGROUND', 'citation': 'Dahlem P, van Aalderen WM, de Neef M, Dijkgraaf MG, Bos AP. Randomized controlled trial of aerosolized prostacyclin therapy in children with acute lung injury. Crit Care Med. 2004 Apr;32(4):1055-60. doi: 10.1097/01.ccm.0000120055.52377.bf.'}, {'pmid': '22851816', 'type': 'BACKGROUND', 'citation': 'Dorris SL, Peebles RS Jr. PGI2 as a regulator of inflammatory diseases. Mediators Inflamm. 2012;2012:926968. doi: 10.1155/2012/926968. Epub 2012 Jul 18.'}, {'pmid': '12082102', 'type': 'BACKGROUND', 'citation': 'Raychaudhuri B, Malur A, Bonfield TL, Abraham S, Schilz RJ, Farver CF, Kavuru MS, Arroliga AC, Thomassen MJ. The prostacyclin analogue treprostinil blocks NFkappaB nuclear translocation in human alveolar macrophages. J Biol Chem. 2002 Sep 6;277(36):33344-8. doi: 10.1074/jbc.M203567200. Epub 2002 Jun 24.'}, {'pmid': '33095030', 'type': 'DERIVED', 'citation': 'Ford HJ, Anderson WH, Wendlandt B, Bice T, Ceppe A, Lanier J, Carson SS. Randomized, Placebo-controlled Trial of Inhaled Treprostinil for Patients at Risk for Acute Respiratory Distress Syndrome. Ann Am Thorac Soc. 2021 Apr;18(4):641-647. doi: 10.1513/AnnalsATS.202004-374OC.'}]}, 'descriptionModule': {'briefSummary': 'Acute Respiratory Distress Syndrome (ARDS) is a rapidly progressing lung disease caused by a number of factors including pneumonia, sepsis and acute trauma that leads to reduced lung function and breathlessness. There are no pharmacological treatments approved for the treatment of ARDS. This pilot trial will study the safety and efficacy of Treprostinil sodium by inhalation for preventing the progression of acute hypoxemic respiratory failure to positive pressure ventilation and/or ARDS in patients at high risk.', 'detailedDescription': 'ARDS is defined by acute hypoxemia, respiratory failure and the presence of bilateral lung infiltrates. ARDS is a syndrome of inflammation and increased permeability that may coexist with left atrial or pulmonary capillary hypertension. Several recent trials in ARDS / ALI (Acute Lung Injury) have generated interest in the use of Prostacyclin (PGI2) and prostacyclin analogs in improving oxygenation in ARDS / ALI. PGI2 is an arachidonic acid metabolite naturally produced in the lung by endothelial cells, dendritic cells, smooth muscle cells and fibroblasts. PGI2 is a potent selective pulmonary vasodilator and inhibitor of platelet aggregation. The cellular effects include smooth muscle relaxation, inhibition of cell migration, decreased dextran permeability in epithelial cell cultures in vitro, decreased high tidal volume mechanical ventilation injury in mice and inhibition of fibroblast adhesion and differentiation. PGI2 has broad anti-inflammatory activity, inhibiting the production of Tumor necrosis factor alpha (TNFα), interleukin 1 beta (IL-1β), interleukin 6 (IL-6) and granulocyte macrophage colony-stimulating factor (GMCSF) in human alveolar macrophages.\n\nThe study objectives are:\n\n1. To assess the feasibility of a randomized trial of treprostinil inhalation in patients with acute hypoxemic respiratory failure not requiring positive pressure ventilation.\n2. To evaluate the tolerability of inhaled treprostinil for patients with acute hypoxemic respiratory failure\n3. To assess the effect of treprostinil inhalation on oxygenation in patients with acute hypoxic respiratory failure with, or at risk for, development of ARDS\n4. To assess the effect of treprostinil inhalation on various biomarkers thought to be related to the pathogenesis and/or clinical course of ARDS.\n\nThe hypothesis is: Treprostinil solution for inhalation (TYVASO) is safe and will improve oxygenation and other secondary outcomes related to acute hypoxemic respiratory failure and positive pressure ventilation initiation and duration, as well as exhibit effects on ARDS-related pro-inflammatory and pro-fibrotic biomarkers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults age 18-75 years.\n2. Acute onset need for 4 liters per minute (LPM) or more of supplemental oxygen to maintain Arterial partial pressure of oxygen (PaO2) \\> 60 mmHg or arterial O2 saturation \\> 90% by pulse oximetry.\n3. Acute unilateral pulmonary infiltrate/s on chest radiograph with no clinical evidence of left-sided heart failure. Bilateral infiltrates are acceptable as long as all other inclusion/exclusion criteria are met.\n\nExclusion Criteria:\n\n1. No consent/inability to obtain consent\n2. Presence of pulmonary embolism\n3. Known diffuse alveolar hemorrhage from vasculitis\n4. Known pre-existing severe obstructive or restrictive lung disease (FEV 1 \\< 40% predicted, total lung capacity (TLC) \\< 50 % predicted) or need for long-term supplemental oxygen therapy\n5. Known significant left ventricular systolic dysfunction with left ventricular ejection fraction (LVEF) \\< 45% on echocardiogram.\n6. Mean arterial pressure \\< 65 mmHg\n7. Need for norepinephrine or dopamine dose \\> 12 mcg to maintain mean arterial pressure (MAP) \\> 65 mmHg\n8. Severe chronic liver disease (Child-Pugh Score 11-15)\n9. Moribund patient not expected to survive 24 hours\n10. Corrected QT interval (QTc) interval \\> 500 ms on screening electrocardiogram\n11. Pregnancy or breast feeding (Women of childbearing potential, defined as \\< 60 years of age, will require pregnancy testing.)\n12. Burns \\> 40% total body surface\n13. Acute Neurological Disease (that may impair the ability to ventilate without assistance)\n14. Imminent need for intubation or non-invasive ventilation\n15. Patient is Do Not Resuscitate/Do Not Intubate\n16. Patient has a tracheotomy\n17. Patient is currently receiving prostacyclin therapy \\[Epoprostenol (Flolan or Veletri), Iloprost (Ventavis), Treprostinil (Orenitram, oral) (Remodulin, IV or SC)\\]\n18. Patient has a language barrier'}, 'identificationModule': {'nctId': 'NCT02370095', 'briefTitle': 'Treprostinil Sodium Inhalation for Patients At High Risk for ARDS', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': 'Treprostinil Sodium Inhalation for Patients At High Risk for ARDS: Effect on Oxygenation and Disease-related Biomarkers', 'orgStudyIdInfo': {'id': '14-0490'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treprostinil inhalation solution', 'description': 'Treprostinil will be randomized 2:1 to placebo. Treprostinil (6 mcg per breath) will be administered every 4 hours. The dose will increase from 6 to12 breaths (maximum 72 mcg) over the first 20 hours, maintained for 7 days, and tapered down over 3 days.', 'interventionNames': ['Drug: Treprostinil Inhalation Solution']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo administration will be administered as above for the active arm', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Treprostinil Inhalation Solution', 'type': 'DRUG', 'otherNames': ['TYVASO'], 'description': 'Treprostinil inhalation solution administered as blinded marketed product', 'armGroupLabels': ['Treprostinil inhalation solution']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sterile saline solution'], 'description': 'Supplied by the manufacturer and similar to the active drug but containing no Treprostinil', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina Hospitals', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Hubert J Ford, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Shannon Carson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}, {'name': 'Wayne H Anderson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'only summary data via publication/abstract'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'United Therapeutics', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}