Ignite Creation Date:
2025-12-25 @ 1:15 AM
Ignite Modification Date:
2025-12-25 @ 11:24 PM
Study NCT ID:
NCT00434993
Status:
TERMINATED
Last Update Posted:
2017-02-10
First Post:
2007-01-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Drug Study of Albuterol to Treat Acute Lung Injury
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': 'D000420', 'term': 'Albuterol'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D010627', 'term': 'Phenethylamines'}, {'id': 'D005021', 'term': 'Ethylamines'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dschoenfeld@partners.org', 'phone': '617-726-6111', 'title': 'David Schoenfeld, ARDSNet CCC PI', 'organization': 'Acute Respiratory Distress Syndrome (ARDS) Network'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Albuterol Sulfate', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours', 'otherNumAtRisk': 152, 'otherNumAffected': 21, 'seriousNumAtRisk': 152, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours', 'otherNumAtRisk': 130, 'otherNumAffected': 15, 'seriousNumAtRisk': 130, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Arrhythmias (clinically important)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 29, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 11, 'numAffected': 8}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART 5.0'}, {'term': 'Hypokalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 12, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 13, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART 5.0'}], 'seriousEvents': [{'term': 'Hypoxemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART 5.0'}, {'term': 'Hypoxia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 152, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'COSTART 5.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Ventilator Free Days (VFD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '14.4', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '16.6', 'spread': '0.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.087', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.2', 'ciLowerLimit': '-4.7', 'ciUpperLimit': '0.3', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.3', 'groupDescription': 'The trial had a statistical power of 90.7% to detect a 2.25-day increase in VFDs,assuming a SD of 10.5 days. A group sequential design was used.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline shock.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Determined 28 days after a subject entered the study', 'description': 'Ventilator-free days (VFDs) is defined as the number of days from randomization to Day 28 after achieving unassisted breathing for patients who maintained unassisted breathing for at least two consecutive calendar days. If a patient achieved unassisted breathing, subsequently required additional assisted breathing, and once again achieved unassisted breathing, we counted only the VFDs after beginning the final period of unassisted breathing. Patients who died before Day 28 were assigned zero VFDs.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All the intent to treat patients were analyzed. Data was available on all subjects for the primary analysis only.'}, {'type': 'SECONDARY', 'title': 'Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '23.0', 'groupId': 'OG000'}, {'value': '17.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.302', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.3', 'ciLowerLimit': '-4.0', 'ciUpperLimit': '14.7', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline shock.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Determined 60 days after a subject entered the study', 'description': "Success for this efficacy variable was defined as being alive on study day 60 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those subjects alive in hospital at day 60 were considered to have survived.", 'unitOfMeasure': 'percentage of participants who died', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat population.'}, {'type': 'SECONDARY', 'title': 'Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '24.3', 'groupId': 'OG000'}, {'value': '18.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.261', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '5.9', 'ciLowerLimit': '-3.7', 'ciUpperLimit': '15.4', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline shock.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Determined 90 days after a subject entered the study', 'description': "Success for this efficacy variable was defined as being alive on study day 90 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those participants who still remained in the hospital at 90 days after randomization were considered to have survived.", 'unitOfMeasure': 'percentage of participants who died', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat.'}, {'type': 'SECONDARY', 'title': 'Number of ICU-free Days at 28 Days After Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '13.5', 'spread': '0.8', 'groupId': 'OG000'}, {'value': '16.2', 'spread': '0.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.023', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.7', 'ciLowerLimit': '-4.9', 'ciUpperLimit': '-0.4', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline shock.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Determined 28 days after a subject entered the study', 'description': 'ICU (intensive care unit)-free days was defined as the number of days a subject was out of the ICU during study hospitalization from date of randomization up to study day 28. All incidences of ICU admission and discharge during the study hospitalization were captured. Any portion of a calendar day that a subject was in the ICU was counted as an ICU day.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat.'}, {'type': 'SECONDARY', 'title': 'Number of Organ Failure-free Days at Day 28 Following Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '14.2', 'spread': '0.9', 'groupId': 'OG000'}, {'value': '15.9', 'spread': '1.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.226', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-1.7', 'ciLowerLimit': '-4.3', 'ciUpperLimit': '0.9', 'pValueComment': 'The p-value was not adjusted for multiple comparisons.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline shock.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Daily from baseline to study day 28', 'description': 'Subjects were followed for development of organ failures from date of randomization to hospital discharge or study day 28, whichever was first. Organ failure was defined as present on any calendar day when the most abnormal vital signs or clinically available lab value met the definition of clinically significant organ failure according to the Brussels Organ Failure Table. Each day a patient was alive and free of a given clinically significant organ failure was scored as a failure-free day. The worst value for a calendar day was captured (lowest systolic BP, platelet count and highest creatinine and bilirubin values). Specific definitions of organ failure were: cardiovascular-systolic BP less than or equal to 90 mmHg or on a vasopressor; coagulation-platelet count less than or equal to 80 x 1000/mm3; Renal-creatinine less than or equal to 2.0 mg/dL; Hepatic-bilirubin less than or equal to 2.0 mg/dL.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent to treat.'}, {'type': 'SECONDARY', 'title': 'Ventilator Free Days to Day 28 in the Subset of Participants With ARDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '1.1', 'groupId': 'OG000', 'lowerLimit': '14', 'upperLimit': '22'}, {'value': '16.8', 'spread': '1.0', 'groupId': 'OG001', 'lowerLimit': '19', 'upperLimit': '23'}]}]}], 'analyses': [{'pValue': '0.130', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.3', 'ciLowerLimit': '-5.3', 'ciUpperLimit': '0.6', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline shock.', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Determined 28 days after a subject entered the study', 'description': 'Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200). P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2. VFD to Day 28 is defined as the number of days from the end of ventilation to day 28 in patients who maintained unassisted breathing for at least two consecutive calendar days. Patients who died before day 28 were assigned a VFD count of zero. If a patient returned to assisted breathing, subsequently required assisted breathing, and once again achieved unassisted breathing, only the VFDs after beginning the final period of unassisted breathing were counted. An increase in the number of VFDs was considered a positive result.', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset.'}, {'type': 'SECONDARY', 'title': 'Hospital Mortality to Day 60 in the Subset of Participants With ARDS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '106', 'groupId': 'OG000'}, {'value': '86', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '24.5', 'groupId': 'OG000'}, {'value': '16.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.176', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '8.2', 'ciLowerLimit': '-3.1', 'ciUpperLimit': '19.6', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Adjusted for baseline shock.', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Determined 60 days after a subject entered the study', 'description': 'Difference in the main outcome mortality to study day 60 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200) prior to randomization. P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2.', 'unitOfMeasure': 'percentage of participants who died', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients meeting the criteria for ARDS (pre-randomization PaO2/FiO2 ratio less than or equal to 200) were selected for this subset.'}, {'type': 'SECONDARY', 'title': 'Ventilator Free Days to Day 28 in the Subset of Patients With Baseline Shock', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '10.0', 'spread': '1.3', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '18'}, {'value': '13.9', 'spread': '1.4', 'groupId': 'OG001', 'lowerLimit': '10', 'upperLimit': '22'}]}]}], 'analyses': [{'pValue': '0.048', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-3.9', 'ciLowerLimit': '-7.8', 'ciUpperLimit': '-0.0', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Determined 28 days after a subject entered the study', 'description': 'Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure\\<60 or the need for vasopressors (except dopamine \\<6 ug/kg/min).', 'unitOfMeasure': 'days', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with protocol defined shock (mean arterial pressure\\<60 or need for vasopressors except dopamine \\< 6ug/kg/min) at the time of study entry.'}, {'type': 'SECONDARY', 'title': 'Hospital Mortality up to Day 60 in Subjects With Baseline Shock', 'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'OG000'}, {'value': '55', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '36.8', 'groupId': 'OG000'}, {'value': '27.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.265', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '9.5', 'ciLowerLimit': '-6.9', 'ciUpperLimit': '25.9', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Determined 60 days after a subject entered the study', 'description': 'Difference in the main outcome hospital mortality to study day 60 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure\\<60 or the need for vasopressors (except dopamine \\<6 ug/kg/min).', 'unitOfMeasure': 'percentage of participants who died', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients with protocol defined shock (mean arterial pressure\\<60 or need for vasopressors except dopamine \\< 6ug/kg/min) at the time of study entry.'}, {'type': 'SECONDARY', 'title': 'Plasma Levels of IL-6 and IL-8 on Study Day 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '110', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Albuterol', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}], 'classes': [{'title': 'IL6', 'categories': [{'measurements': [{'value': '1.9', 'spread': '0.6', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '0.7', 'groupId': 'OG001'}]}]}, {'title': 'IL8', 'categories': [{'measurements': [{'value': '1.7', 'spread': '0.5', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '0.5', 'groupId': 'OG001'}]}]}], 'paramType': 'LOG_MEAN', 'timeFrame': 'Measured at baseline and 3 days after randomization', 'description': "Biologic end-points were selected that would provide mechanistic insight into how albuterol improved lung function. Concentrations of two proinflammatory cytokines, interleukin 6 and 8 (IL-6 and IL-8), were measured. Plasma was collected and cytokine levels were measured at baseline and 3 days after randomization. IL-6 and IL-8 levels were normalized using log transformation. Wilcoxon's test was used to compare mean log-transformed interleukin levels per day and a mixed-effects model was fit to compare the slopes.", 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Not all subjects had available data for secondary analyses and therefor the numbers will be less than the 152 (active) and 130 (placebo) arms.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Albuterol Sulfate', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '130'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The trial was conducted with a combined Phase II/III design to enroll 1000 patients with a safety review performed after 100 subjects were enrolled and interim analysis looks at 250, 500, and 700 subjects. The first subject was entered in August 2007 and the last subject in July of 2008 when the study was stopped for futility at 282 enrolled.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Albuterol Sulfate', 'description': 'Aerosolized albuterol sulfate (5.0 mg dissolved in saline) every 4 hours'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Preservative-free 0.9% sterile sodium chloride every 4 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '111', 'groupId': 'BG000'}, {'value': '100', 'groupId': 'BG001'}, {'value': '211', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '66', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '52.3', 'spread': '16.4', 'groupId': 'BG000'}, {'value': '50.9', 'spread': '16.2', 'groupId': 'BG001'}, {'value': '51.6', 'spread': '16.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Gender', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '67', 'groupId': 'BG000'}, {'value': '59', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '85', 'groupId': 'BG000'}, {'value': '71', 'groupId': 'BG001'}, {'value': '156', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '130', 'groupId': 'BG001'}, {'value': '282', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'All randomized patients were analyzed.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 282}}, 'statusModule': {'whyStopped': 'Stopped for futility by DSMB', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-12', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-12-21', 'studyFirstSubmitDate': '2007-01-29', 'resultsFirstSubmitDate': '2012-12-04', 'studyFirstSubmitQcDate': '2007-02-12', 'lastUpdatePostDateStruct': {'date': '2017-02-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-06-07', 'studyFirstPostDateStruct': {'date': '2007-02-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-07-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Ventilator Free Days (VFD)', 'timeFrame': 'Determined 28 days after a subject entered the study', 'description': 'Ventilator-free days (VFDs) is defined as the number of days from randomization to Day 28 after achieving unassisted breathing for patients who maintained unassisted breathing for at least two consecutive calendar days. If a patient achieved unassisted breathing, subsequently required additional assisted breathing, and once again achieved unassisted breathing, we counted only the VFDs after beginning the final period of unassisted breathing. Patients who died before Day 28 were assigned zero VFDs.'}], 'secondaryOutcomes': [{'measure': 'Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 60', 'timeFrame': 'Determined 60 days after a subject entered the study', 'description': "Success for this efficacy variable was defined as being alive on study day 60 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those subjects alive in hospital at day 60 were considered to have survived."}, {'measure': 'Mortality Prior to Hospital Discharge With Unassisted Breathing to Day 90', 'timeFrame': 'Determined 90 days after a subject entered the study', 'description': "Success for this efficacy variable was defined as being alive on study day 90 or having been discharged alive off mechanical ventilation from the study hospital (or subsequent hospital) to the subject's original place of residence. Those participants who still remained in the hospital at 90 days after randomization were considered to have survived."}, {'measure': 'Number of ICU-free Days at 28 Days After Randomization', 'timeFrame': 'Determined 28 days after a subject entered the study', 'description': 'ICU (intensive care unit)-free days was defined as the number of days a subject was out of the ICU during study hospitalization from date of randomization up to study day 28. All incidences of ICU admission and discharge during the study hospitalization were captured. Any portion of a calendar day that a subject was in the ICU was counted as an ICU day.'}, {'measure': 'Number of Organ Failure-free Days at Day 28 Following Randomization', 'timeFrame': 'Daily from baseline to study day 28', 'description': 'Subjects were followed for development of organ failures from date of randomization to hospital discharge or study day 28, whichever was first. Organ failure was defined as present on any calendar day when the most abnormal vital signs or clinically available lab value met the definition of clinically significant organ failure according to the Brussels Organ Failure Table. Each day a patient was alive and free of a given clinically significant organ failure was scored as a failure-free day. The worst value for a calendar day was captured (lowest systolic BP, platelet count and highest creatinine and bilirubin values). Specific definitions of organ failure were: cardiovascular-systolic BP less than or equal to 90 mmHg or on a vasopressor; coagulation-platelet count less than or equal to 80 x 1000/mm3; Renal-creatinine less than or equal to 2.0 mg/dL; Hepatic-bilirubin less than or equal to 2.0 mg/dL.'}, {'measure': 'Ventilator Free Days to Day 28 in the Subset of Participants With ARDS', 'timeFrame': 'Determined 28 days after a subject entered the study', 'description': 'Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200). P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2. VFD to Day 28 is defined as the number of days from the end of ventilation to day 28 in patients who maintained unassisted breathing for at least two consecutive calendar days. Patients who died before day 28 were assigned a VFD count of zero. If a patient returned to assisted breathing, subsequently required assisted breathing, and once again achieved unassisted breathing, only the VFDs after beginning the final period of unassisted breathing were counted. An increase in the number of VFDs was considered a positive result.'}, {'measure': 'Hospital Mortality to Day 60 in the Subset of Participants With ARDS', 'timeFrame': 'Determined 60 days after a subject entered the study', 'description': 'Difference in the main outcome mortality to study day 60 was calculated for the subset of patients with ARDS (defined as a PaO2/FiO2 ratio of less than or equal to 200) prior to randomization. P/F ratio is an index of the effectiveness of arterial oxygenation that corresponds to the ratio of partial pressure of arterial O2 to the fraction of inspired O2.'}, {'measure': 'Ventilator Free Days to Day 28 in the Subset of Patients With Baseline Shock', 'timeFrame': 'Determined 28 days after a subject entered the study', 'description': 'Difference in the main outcome Ventilator Free Days to study day 28 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure\\<60 or the need for vasopressors (except dopamine \\<6 ug/kg/min).'}, {'measure': 'Hospital Mortality up to Day 60 in Subjects With Baseline Shock', 'timeFrame': 'Determined 60 days after a subject entered the study', 'description': 'Difference in the main outcome hospital mortality to study day 60 was calculated for the subset of patients who were in shock at the time of randomization. Shock was defined as mean arterial pressure\\<60 or the need for vasopressors (except dopamine \\<6 ug/kg/min).'}, {'measure': 'Plasma Levels of IL-6 and IL-8 on Study Day 3', 'timeFrame': 'Measured at baseline and 3 days after randomization', 'description': "Biologic end-points were selected that would provide mechanistic insight into how albuterol improved lung function. Concentrations of two proinflammatory cytokines, interleukin 6 and 8 (IL-6 and IL-8), were measured. Plasma was collected and cytokine levels were measured at baseline and 3 days after randomization. IL-6 and IL-8 levels were normalized using log transformation. Wilcoxon's test was used to compare mean log-transformed interleukin levels per day and a mixed-effects model was fit to compare the slopes."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Acute Lung Injury', 'Acute Respiratory Distress Syndrome', 'Albuterol', 'Aerosolized', 'Critical Care', 'Ventilator'], 'conditions': ['Respiratory Distress Syndrome, Adult']}, 'referencesModule': {'availIpds': [{'id': 'ARDSNet-ALTA', 'url': 'http://biolincc.nhlbi.nih.gov/studies/alta/', 'type': 'Individual Participant Data Set', 'comment': 'NHLBI provides controlled access to IPD through BioLINCC. Access requires registration, evidence of local IRB approval or certification of exemption from IRB review, and completion of a data use agreement.'}, {'url': 'http://biolincc.nhlbi.nih.gov/studies/alta/', 'type': 'Study Protocol'}, {'url': 'http://biolincc.nhlbi.nih.gov/studies/alta/', 'type': 'Study Forms'}], 'references': [{'pmid': '27440140', 'type': 'DERIVED', 'citation': 'Brown SM, Wilson E, Presson AP, Zhang C, Dinglas VD, Greene T, Hopkins RO, Needham DM; with the National Institutes of Health NHLBI ARDS Network. Predictors of 6-month health utility outcomes in survivors of acute respiratory distress syndrome. Thorax. 2017 Apr;72(4):311-317. doi: 10.1136/thoraxjnl-2016-208560. Epub 2016 Jul 20.'}, {'pmid': '26138630', 'type': 'DERIVED', 'citation': 'Ambrus DB, Benjamin EJ, Bajwa EK, Hibbert KA, Walkey AJ. Risk factors and outcomes associated with new-onset atrial fibrillation during acute respiratory distress syndrome. J Crit Care. 2015 Oct;30(5):994-7. doi: 10.1016/j.jcrc.2015.06.003. Epub 2015 Jun 16.'}, {'pmid': '21562125', 'type': 'DERIVED', 'citation': 'National Heart, Lung, and Blood Institute Acute Respiratory Distress Syndrome (ARDS) Clinical Trials Network; Matthay MA, Brower RG, Carson S, Douglas IS, Eisner M, Hite D, Holets S, Kallet RH, Liu KD, MacIntyre N, Moss M, Schoenfeld D, Steingrub J, Thompson BT. Randomized, placebo-controlled clinical trial of an aerosolized beta(2)-agonist for treatment of acute lung injury. Am J Respir Crit Care Med. 2011 Sep 1;184(5):561-8. doi: 10.1164/rccm.201012-2090OC.'}], 'seeAlsoLinks': [{'url': 'http://www.ardsnet.org', 'label': 'NHLBI Acute Respiratory Distress Syndrome Network Website'}]}, 'descriptionModule': {'briefSummary': 'Acute Respiratory Distress Syndrome (ARDS) and a lesser condition that occurs prior to ARDS, Acute Lung Injury (ALI), are medical conditions that occur when there is severe inflammation and increased fluids (edema) in both lungs, making it hard for the lungs to function properly. Patients with these conditions require treatment that includes the use of a breathing machine (ventilator). The purpose of this study is to find out whether giving albuterol (a drug commonly used in asthmatics) or not giving albuterol to patients with ALI or ARDS makes a difference in how long it takes for a patient to be able to breath without the ventilator.', 'detailedDescription': 'Aerosolized beta-2 agonist therapy is anticipated to diminish the formation of lung edema, enhance clearance of lung edema and decrease pulmonary inflammation in patients with acute lung injury. Because beta-2 agonists have been shown to reduce permeability induced lung injury, it is anticipated that the severity of lung injury will be reduced by aerosolized beta-2 agonist therapy. The therapy may work by enhancing resolution of pulmonary edema by upregulating alveolar epithelial fluid transport mechanisms that will in turn enhance the clearance of alveolar edema. A reduction in the severity of lung injury and the quantity of alveolar edema should result in earlier extubation and more ventilator free days, improved pulmonary oxygen uptake, and improved lung compliance.\n\nStudy design: phase II/III prospective, randomized double-blind, placebo controlled trial.\n\n* In Phase II, patients will be treated with aerosolized albuterol 5.0 mg vs. normal saline (n=40-50)administered every 4 hours for 10 days following randomization or until 24 hours following extubation, whichever occurs first. The protocol stipulates that the 5.0 mg dose will be reduced to 2.5 mg if patients exceed defined heart rate limits.\n* In Phase III, the 5.0 mg dose will be used unless there is evidence that this dose has an unacceptable safety profile or dose reductions for tachycardia occur in a large fraction of patients. In that case, a lower dose of 2.5 mg will be used.\n* Patients will be followed for 90 days or until discharge from the hospital to home with unassisted breathing whichever occurs first.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '13 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must meet the following three criteria within a 24-hour period:\n\n 1. Acute onset of PaO2/FiO2 less than or equal to 300 (adjustments made for altitude where appropriate)\n 2. Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph\n 3. Requirement for positive pressure ventilation via endotracheal tube\n* No clinical evidence of left-sided cardiac failure to account for bilateral pulmonary infiltrates\n\nExclusion Criteria:\n\n* Greater than 48 hours since all inclusion criteria are met\n* Neuromuscular disease that impairs ability to ventilate without assistance, (e.g., cervical spinal cord injury at level C5 or higher spinal cord injury amyotrophic lateral sclerosis, Guillain-Barré syndrome or myasthenia gravis)\n* Pregnant or breast-feeding\n* Severe chronic respiratory disease (i.e., chronic hypercapnia \\[PaCO2 greater than 45 mmHg\\], chronic hypoxemia \\[PaO2 less than 55 mmHg on FiO2 = 0.21\\], hospitalization within the last 6 months for respiratory failure \\[PaCO2 greater than 50 mm Hg and/or PaO2 less than 55 mmHg on 0.21 FiO2\\], secondary polycythemia, severe pulmonary hypertension \\[mean PAP (pulmonary artery pressure) greater than 40 mmHg\\], or ventilator dependency)\n* Burns over greater than 40% of total body surface area\n* Cancer or other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%\n* Allogeneic bone marrow transplant within the 5 years prior to study entry\n* Participant, surrogate, or physician is not committed to full support (Exception: a participant will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)\n* Severe chronic liver disease (Child-Pugh score of 11-15)\n* Diffuse alveolar hemorrhage from vasculitis\n* Morbid obesity (greater than 1kg/cm body weight.)\n* Unwillingness or inability to utilize the ARDS network 6 ml / kg Predicted Body Weight (PBW) ventilation protocol\n* Moribund participant and is not expected to survive 24 hours\n* No intent to obtain central venous access for monitoring intravascular pressures\n* Contraindication to aerosolized albuterol (see Appendix A.8 of the protocol for more information)\n* Daily use (prior to study hospitalization) of inhaled beta agonist, corticosteroid, or oral leukotriene modifier\n* Unwillingness of primary physician to discontinue inpatient beta agonist use\n* Acute myocardial infarction or acute coronary syndrome within 30 days of study entry\n* Severe congestive heart failure (see Appendix A5 of the protocol for more information)\n* Participation in other experimental medication trial within 30 days of study entry with the exception of the ARDSNet pharmaconutrient nutrition trial (OMEGA)\n* Heart rate greater than 85% of maximal predicted heart rate (MHR85) as calculated by MHR85 = 85% x (220-age)\n* Currently receiving high frequency ventilation'}, 'identificationModule': {'nctId': 'NCT00434993', 'acronym': 'ALTA', 'briefTitle': 'Drug Study of Albuterol to Treat Acute Lung Injury', 'organization': {'class': 'NIH', 'fullName': 'National Heart, Lung, and Blood Institute (NHLBI)'}, 'officialTitle': 'Prospective, Randomized, Multicenter Trial of Aerosolized Albuterol Versus Placebo in Acute Lung Injury', 'orgStudyIdInfo': {'id': '474'}, 'secondaryIdInfos': [{'id': 'N01HR056179', 'link': 'https://reporter.nih.gov/quickSearch/N01HR056179', 'type': 'NIH'}, {'id': 'HHSN268200536179C'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Albuterol Sulfate', 'interventionNames': ['Drug: Albuterol Sulfate', 'Procedure: Mini-Bronchoalveolar Lavage (BAL)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Procedure: Mini-Bronchoalveolar Lavage (BAL)', 'Drug: Placebo']}], 'interventions': [{'name': 'Albuterol Sulfate', 'type': 'DRUG', 'otherNames': ['0.9% sodium chloride'], 'description': 'Albuterol sulfate, USP, solution for inhalation will be diluted as follows:\n\n* The full dose of 5.0 mg will be diluted into 2.0 ml of sterile normal saline solution.\n* The reduced dose of 2.5 mg will be diluted into 2.5 ml of sterile normal saline solution.\n\nA high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization. The study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first.', 'armGroupLabels': ['Albuterol Sulfate']}, {'name': 'Mini-Bronchoalveolar Lavage (BAL)', 'type': 'PROCEDURE', 'otherNames': ['Combicath'], 'description': 'The mini-BAL procedure involves blind specimen sampling from distal airspaces. Specimens are obtained with the Combicath (Plastimed) catheter. The procedure will be done on study days 0 and 3', 'armGroupLabels': ['Albuterol Sulfate', 'Placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['0.9% sodium chloride'], 'description': 'Placebo aerosol will consist of 3.0 ml of identical appearing sterile 0.9 % sodium chloride without preservative.\n\nA high-efficiency small volume jet nebulizer (SVN) powered at a flow of 8 liters/minute from a 50 psi wall oxygen flow meter will be used for continuous nebulization (e.g.: throughout the inspiratory and expiratory cycle).\n\nThe study drug will be given every 4 hours (plus or minus one hour) for ten days following randomization or until 24 hours after extubation, whichever occurs first.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'University of San Francisco-Fresno Medical Center', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Davis Medical Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF-Moffitt Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF-San Francisco General Hospital', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Centura St. Anthony Central Hospital', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Denver Health Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Rose Medical Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Health Sciences Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Washington Hospital Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Baton Rouge General Hospital-Blue Bonnet', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Baton Rouge General Hospital-Midcity', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Earl K. Long Medical Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Our Lady of the Lake Regional Medical Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Medical Center of Louisiana', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Clinic Foundation', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Tulane University Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Baltimore VA Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Bayview Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins Hospital', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Shock Trauma Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'city': 'Springfield', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Baystate Medical Center', 'geoPoint': {'lat': 42.10148, 'lon': -72.58981}}, {'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Rochester Methodist Hospital', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': "St. Mary's Hospital, Mayo Clinic", 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Durham Regional Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Moses Cone Health System', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wesley Long Community Hospital', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest University Baptist Medical Center', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'MetroHealth Medical Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Hospitals of Cleveland', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Ogden', 'state': 'Utah', 'country': 'United States', 'facility': 'McKay-Dee Hospital', 'geoPoint': {'lat': 41.223, 'lon': -111.97383}}, {'city': 'Provo', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Valley Regional Medical Center', 'geoPoint': {'lat': 40.23384, 'lon': -111.65853}}, {'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'LDS Hospital', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Medical Center', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'University of Washington', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Michael A. Matthay, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Roy Brower, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'a deidentified database of the ALVEOLI study is available through BioLINCC'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}