Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-31 @ 3:39 PM
Study NCT ID:
NCT06922760
Status:
COMPLETED
Last Update Posted:
2025-11-18
First Post:
2025-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001249', 'term': 'Asthma'}], 'ancestors': [{'id': 'D001982', 'term': 'Bronchial Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'nlugogo@med.umich.edu', 'phone': '734-647-6477', 'title': 'Njira Lugogo', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'Adverse event data was not collected, as this was a retrospective observational study.', 'eventGroups': [{'id': 'EG000', 'title': 'University of Michigan, Ann Arbor, MI', 'description': 'Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'National Jewish Health, Denver, CO', 'description': 'Severe asthma patients treated at National Jewish Health who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Chest Wall Muscle Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'University of Michigan, Ann Arbor, MI', 'description': 'Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}, {'id': 'OG001', 'title': 'National Jewish Health, Denver, CO', 'description': 'Severe asthma patients treated at National Jewish Health who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}], 'classes': [{'title': 'Had reduction in exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '95.49', 'spread': '25.63', 'groupId': 'OG000'}, {'value': '97.82', 'spread': '29.04', 'groupId': 'OG001'}]}]}, {'title': 'Did not have reduction in exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '87.98', 'spread': '23.65', 'groupId': 'OG000'}, {'value': '102.86', 'spread': '28.77', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 months', 'description': 'Muscle size was measured as the skeletal muscle cross-sectional area in centimeters squared (cm2) measured at the level of the T10 vertebra to determine the cutoff value in chest wall muscle size that optimally classified patients that had and did not have any reduction in pre-treatment baseline exacerbation frequency (binary).', 'unitOfMeasure': 'cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '8 participants in the University of Michigan arm and 1 participant in the National Jewish Health arm did not have either a baseline or post-treatment count of exacerbations so the outcome could not be computed for them. In addition, 20 participants in the National Jewish Health arm (including the 1 without complete outcome data) did not have complete skeletal muscle visible within the scan field, so muscle size and quality could not be adequately assessed.'}, {'type': 'PRIMARY', 'title': 'Chest Wall Muscle Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'University of Michigan, Ann Arbor, MI', 'description': 'Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}, {'id': 'OG001', 'title': 'National Jewish Health, Denver, CO', 'description': 'Severe asthma patients treated at National Jewish Health who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}], 'classes': [{'title': 'Had a reduction in exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '122', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.57', 'spread': '7.94', 'groupId': 'OG000'}, {'value': '30.27', 'spread': '7.28', 'groupId': 'OG001'}]}]}, {'title': 'Did not have reduction in exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '22', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '39.18', 'spread': '6.96', 'groupId': 'OG000'}, {'value': '28.60', 'spread': '6.43', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '28 months', 'description': 'Muscle quality was measured as the skeletal muscle density in Hounsfield Units (HU) to determine the cutoff value in chest wall muscle quality that optimally classified patients that had and did not have any reduction in pre-treatment baseline exacerbation frequency (binary).', 'unitOfMeasure': 'HU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '8 participants in the University of Michigan arm and 1 participant in the National Jewish Health arm did not have either a baseline or post-treatment count of exacerbations so the outcome could not be computed for them. In addition, 20 participants in the National Jewish Health arm (including the 1 without complete outcome data) did not have complete skeletal muscle visible within the scan field, so muscle size and quality could not be adequately assessed.'}, {'type': 'PRIMARY', 'title': 'Exacerbation Reduction - Muscle Size', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'University of Michigan, Ann Arbor, MI', 'description': 'Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}, {'id': 'OG001', 'title': 'National Jewish Health, Denver, CO', 'description': 'Severe asthma patients treated at National Jewish Health who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '94.3', 'spread': '25.4', 'groupId': 'OG000'}, {'value': '99.3', 'spread': '28.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.411', 'groupIds': ['OG000'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Statistical Test of Hypothesis'}, {'pValue': '0.161', 'groupIds': ['OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Statistical Test of Hypothesis'}], 'paramType': 'MEAN', 'timeFrame': '28 months', 'description': 'Muscle size was measured as the skeletal muscle cross-sectional area in centimeters squared (cm2) measured at the level of the T10 vertebra to assess whether skeletal muscle size area could be used to predict exacerbation frequency. Results reflect the average muscle sizes when frequency could be predicted.', 'unitOfMeasure': 'cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '8 participants in the University of Michigan arm and 1 participant in the National Jewish Health arm did not have either a baseline or post-treatment count of exacerbations so the outcome could not be computed for them. In addition, 20 participants in the National Jewish Health arm (including the 1 without complete outcome data) did not have complete skeletal muscle visible within the scan field, so muscle size and quality could not be adequately assessed.'}, {'type': 'PRIMARY', 'title': 'Exacerbation Reduction - Muscle Quality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'University of Michigan, Ann Arbor, MI', 'description': 'Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}, {'id': 'OG001', 'title': 'National Jewish Health, Denver, CO', 'description': 'Severe asthma patients treated at National Jewish Health who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}], 'classes': [{'categories': [{'measurements': [{'value': '37', 'spread': '7.8', 'groupId': 'OG000'}, {'value': '29.8', 'spread': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.007', 'groupIds': ['OG000'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Statistical Test of Hypothesis'}, {'pValue': '0.5', 'groupIds': ['OG001'], 'statisticalMethod': 'Regression, Linear', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'Statistical Test of Hypothesis'}], 'paramType': 'MEAN', 'timeFrame': '28 months', 'description': 'Muscle quality was measured as the skeletal muscle density in Hounsfield Units (HU) to determine the cutoff value in chest wall muscle quality to assess whether skeletal muscle quality could be used to predict exacerbation frequency. Results reflect the average muscle sizes when frequency could be predicted.', 'unitOfMeasure': 'HU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '8 participants in the University of Michigan arm and 1 participant in the National Jewish Health arm did not have either a baseline or post-treatment count of exacerbations so the outcome could not be computed for them. In addition, 20 participants in the National Jewish Health arm (including the 1 without complete outcome data) did not have complete skeletal muscle visible within the scan field, so muscle size and quality could not be adequately assessed.'}, {'type': 'PRIMARY', 'title': 'Exacerbations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'University of Michigan, Ann Arbor, MI', 'description': 'Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}, {'id': 'OG001', 'title': 'National Jewish Health, Denver, CO', 'description': 'Severe asthma patients treated at National Jewish Health who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}], 'classes': [{'title': 'True', 'categories': [{'measurements': [{'value': '122', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}]}, {'title': 'False', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)', 'description': 'The number of exacerbations post-biologic were compared to the the number of baseline exacerbations. Baseline measurements were counted in the year prior to biologic initiation. Any exacerbation recorded between 4 to 28 months after biologic initiation was recorded as a post-biologic exacerbation. Any reduction in between the pre- and post-biologic was counted as an exacerbation reduction. Results reflect the number of participants who experienced (True) or did not experience (False) a reduction in exacerbations.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '8 participants in the University of Michigan arm and 1 participant in the National Jewish Health arm did not have either a baseline or post-treatment count of exacerbations so the outcome could not be computed for them.'}, {'type': 'SECONDARY', 'title': 'FEV1 Improvement', 'denoms': [{'units': 'Participants', 'counts': [{'value': '104', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'University of Michigan, Ann Arbor, MI', 'description': 'Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}, {'id': 'OG001', 'title': 'National Jewish Health, Denver, CO', 'description': 'Severe asthma patients treated at National Jewish Health who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}], 'classes': [{'title': 'Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '46', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '94.59', 'spread': '25.06', 'groupId': 'OG000'}, {'value': '96.93', 'spread': '32.43', 'groupId': 'OG001'}]}]}, {'title': 'Non-Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '25', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.31', 'spread': '23.85', 'groupId': 'OG000'}, {'value': '102.81', 'spread': '25.26', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)', 'description': 'Muscle size was used to investigate body composition measures associated with a 5% or greater improvement in forced expiratory volume in one second (FEV1). Muscle size was measured as the skeletal muscle cross-sectional area in centimeters squared (cm2) measured at the level of the T10 vertebra to determine the cutoff value in chest wall muscle size that optimally classified participants who had and did not have improvement in FEV1. Participants with ≥5% improvement in FEV1 during the 4 to 18-month period following initiation of biologics were classified as responders. Any participant who did not achieve a ≥5% improvement from baseline in that timeframe was classified as a non-responder.', 'unitOfMeasure': 'cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '48 UM patients and 31 NJ patients that lacked a suitable CT and pre- and post-biologic FEV1 measure were not included in this analysis'}, {'type': 'SECONDARY', 'title': 'Reduction in Oral Corticosteroid (OCS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'University of Michigan, Ann Arbor, MI', 'description': 'Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}, {'id': 'OG001', 'title': 'National Jewish Health, Denver, CO', 'description': 'Severe asthma patients treated at National Jewish Health who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}], 'classes': [{'title': 'Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '33', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '91.17', 'spread': '23.84', 'groupId': 'OG000'}, {'value': '103.94', 'spread': '32.96', 'groupId': 'OG001'}]}]}, {'title': 'Non-Responders', 'denoms': [{'units': 'Participants', 'counts': [{'value': '94', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '96.09', 'spread': '26.17', 'groupId': 'OG000'}, {'value': '97.92', 'spread': '27.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)', 'description': 'Muscle size was used to investigate body composition measures associated with any reduction in maintenance OCS use when compared to baseline OCS use. Subjects with any OCS reduction in use during the 4- to 18-month period following initiation of biologics were classified as responders.', 'unitOfMeasure': 'cm2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '25 UM patients and 20 NJ patients that lacked a suitable CT and pre- and post-biologic OCS maintenance use were not included in this analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'University of Michigan, Ann Arbor, MI', 'description': 'Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}, {'id': 'FG001', 'title': 'National Jewish Health, Denver, CO', 'description': 'Severe asthma patients treated at National Jewish Health who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '152'}, {'groupId': 'FG001', 'numSubjects': '81'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'University of Michigan, Ann Arbor, MI', 'description': 'Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}, {'id': 'BG001', 'title': 'National Jewish Health, Denver, CO', 'description': 'Severe asthma patients treated at National Jewish Health who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '52.39', 'spread': '14.31', 'groupId': 'BG000'}, {'value': '51.75', 'spread': '15.58', 'groupId': 'BG001'}, {'value': '52.17', 'spread': '14.73', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '51.42', 'spread': '13.21', 'groupId': 'BG000'}, {'value': '48.08', 'spread': '17.86', 'groupId': 'BG001'}, {'value': '50.50', 'spread': '14.65', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '54.55', 'spread': '16.46', 'groupId': 'BG000'}, {'value': '55.34', 'spread': '12.15', 'groupId': 'BG001'}, {'value': '54.92', 'spread': '14.53', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data is the specific breakdown of mean participant age by gender.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '105', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '47', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '144', 'groupId': 'BG000'}, {'value': '68', 'groupId': 'BG001'}, {'value': '212', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '21', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '125', 'groupId': 'BG000'}, {'value': '69', 'groupId': 'BG001'}, {'value': '194', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '152', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '81', 'groupId': 'BG001'}, {'value': '233', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '32.46', 'spread': '9.27', 'groupId': 'BG000'}, {'value': '31.70', 'spread': '9.21', 'groupId': 'BG001'}, {'value': '32.25', 'spread': '9.23', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '29.97', 'spread': '4.92', 'groupId': 'BG000'}, {'value': '30.62', 'spread': '5.61', 'groupId': 'BG001'}, {'value': '30.27', 'spread': '5.23', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data is the specific breakdown of mean participant BMI by gender.'}, {'title': 'Height', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '162.31', 'spread': '6.78', 'groupId': 'BG000'}, {'value': '162.84', 'spread': '6.05', 'groupId': 'BG001'}, {'value': '162.45', 'spread': '6.57', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '176.95', 'spread': '6.56', 'groupId': 'BG000'}, {'value': '176.59', 'spread': '7.78', 'groupId': 'BG001'}, {'value': '176.78', 'spread': '7.12', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'centimeters', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data is the specific breakdown of mean participant height by gender.'}, {'title': 'Weight', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '145', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '85.31', 'spread': '23.83', 'groupId': 'BG000'}, {'value': '83.85', 'spread': '23.89', 'groupId': 'BG001'}, {'value': '84.91', 'spread': '23.77', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '88', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '93.99', 'spread': '16.88', 'groupId': 'BG000'}, {'value': '95.43', 'spread': '18.33', 'groupId': 'BG001'}, {'value': '94.66', 'spread': '17.48', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kilograms', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data is the specific breakdown of mean participant weight by gender.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-10-28', 'size': 598333, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-08-12T13:55', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 233}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-04', 'studyFirstSubmitDate': '2025-04-03', 'resultsFirstSubmitDate': '2025-08-17', 'studyFirstSubmitQcDate': '2025-04-03', 'lastUpdatePostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-11-04', 'studyFirstPostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Chest Wall Muscle Size', 'timeFrame': '28 months', 'description': 'Muscle size was measured as the skeletal muscle cross-sectional area in centimeters squared (cm2) measured at the level of the T10 vertebra to determine the cutoff value in chest wall muscle size that optimally classified patients that had and did not have any reduction in pre-treatment baseline exacerbation frequency (binary).'}, {'measure': 'Chest Wall Muscle Quality', 'timeFrame': '28 months', 'description': 'Muscle quality was measured as the skeletal muscle density in Hounsfield Units (HU) to determine the cutoff value in chest wall muscle quality that optimally classified patients that had and did not have any reduction in pre-treatment baseline exacerbation frequency (binary).'}, {'measure': 'Exacerbation Reduction - Muscle Size', 'timeFrame': '28 months', 'description': 'Muscle size was measured as the skeletal muscle cross-sectional area in centimeters squared (cm2) measured at the level of the T10 vertebra to assess whether skeletal muscle size area could be used to predict exacerbation frequency. Results reflect the average muscle sizes when frequency could be predicted.'}, {'measure': 'Exacerbation Reduction - Muscle Quality', 'timeFrame': '28 months', 'description': 'Muscle quality was measured as the skeletal muscle density in Hounsfield Units (HU) to determine the cutoff value in chest wall muscle quality to assess whether skeletal muscle quality could be used to predict exacerbation frequency. Results reflect the average muscle sizes when frequency could be predicted.'}, {'measure': 'Exacerbations', 'timeFrame': 'pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)', 'description': 'The number of exacerbations post-biologic were compared to the the number of baseline exacerbations. Baseline measurements were counted in the year prior to biologic initiation. Any exacerbation recorded between 4 to 28 months after biologic initiation was recorded as a post-biologic exacerbation. Any reduction in between the pre- and post-biologic was counted as an exacerbation reduction. Results reflect the number of participants who experienced (True) or did not experience (False) a reduction in exacerbations.'}], 'secondaryOutcomes': [{'measure': 'FEV1 Improvement', 'timeFrame': 'pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)', 'description': 'Muscle size was used to investigate body composition measures associated with a 5% or greater improvement in forced expiratory volume in one second (FEV1). Muscle size was measured as the skeletal muscle cross-sectional area in centimeters squared (cm2) measured at the level of the T10 vertebra to determine the cutoff value in chest wall muscle size that optimally classified participants who had and did not have improvement in FEV1. Participants with ≥5% improvement in FEV1 during the 4 to 18-month period following initiation of biologics were classified as responders. Any participant who did not achieve a ≥5% improvement from baseline in that timeframe was classified as a non-responder.'}, {'measure': 'Reduction in Oral Corticosteroid (OCS)', 'timeFrame': 'pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)', 'description': 'Muscle size was used to investigate body composition measures associated with any reduction in maintenance OCS use when compared to baseline OCS use. Subjects with any OCS reduction in use during the 4- to 18-month period following initiation of biologics were classified as responders.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Asthma']}, 'descriptionModule': {'briefSummary': 'This study will utilize University of Michigan EMR data to form a retrospective cohort of severe asthma patients on biologic therapies for asthma with computed tomography (CT) imaging and known outcomes on therapy. These images will then be analyzed using morphomics, a combination of high-throughput image analysis and deep learning techniques, to derive imaging biomarkers that will be able to predict therapeutic response to biologics. These biomarkers will then be tested in a second cohort from the National Jewish Health to assess for validity.', 'detailedDescription': 'The two arms for this study represent the two cohorts: the University of Michigan cohort, and the National Jewish Health cohort. The cohorts were split into arms, as the National Jewish Health cohort was intended to act as a validator group for results derived from participants in the University of Michigan cohort.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Approximately 500 male or female subjects ages 18-85 with a diagnosis of asthma, on biologic therapy , and with a pre-biologic CT scan for any clinical purpose drawn from Michigan Medicine EHR (University of Michigan in Ann Arbor, MI, USA) and National Jewish Health (Denver, Colorado, USA).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Asthma diagnosis defined as a positive methacholine test, supportive PFTs, or clinician diagnosis with appropriate supporting clinical context\n* Prescribed and taking an FDA-approved biologic medication for severe asthma (mepolizumab, benralizumab, reslizumab, omalizumab, or dupilumab)\n* Chest computerized tomography (CT) images taken for any clinical purpose\n\nExclusion Criteria:\n\n* 10-year history of smoking\n* Evidence of emphysema on CT imaging\n* Severe bronchiectasis secondary to other causes (subjects with scattered bronchiectasis secondary to severe asthma will not excluded)\n* Lack of accessible adequate follow-up information (4 or more months from drug initiation with clear documentation of response) will be excluded from final analysis due to inability to assess response but will be included in the initial cluster identification'}, 'identificationModule': {'nctId': 'NCT06922760', 'briefTitle': 'Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts', 'orgStudyIdInfo': {'id': 'HUM00140217'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'University of Michigan, Ann Arbor, MI', 'description': 'Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}, {'label': 'National Jewish Health, Denver, CO', 'description': 'Severe asthma patients treated at National Jewish Health who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.\n\nNo interventions were included in this retrospective study.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '80206', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'National Jewish Health', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Njira Lugogo', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine', 'investigatorFullName': 'Njira Lugogo', 'investigatorAffiliation': 'University of Michigan'}}}}