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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| University of Michigan, Ann Arbor, MI | Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy. No interventions were included in this retrospective study. | ||
| National Jewish Health, Denver, CO | 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. No interventions were included in this retrospective study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Chest Wall Muscle Size | 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). | 28 months |
| Chest Wall Muscle Quality | 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). | 28 months |
| Exacerbation Reduction - Muscle Size | 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. | 28 months |
| Exacerbation Reduction - Muscle Quality | 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. | 28 months |
| Exacerbations | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 Improvement | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Njira Lugogo | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Jewish Health | Denver | Colorado | 80206 | United States | ||
| University of Michigan |
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| ID | Title | Description |
|---|---|---|
| FG000 | University of Michigan, Ann Arbor, MI | Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy. No interventions were included in this retrospective study. |
| FG001 | National Jewish Health, Denver, CO | 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. No interventions were included in this retrospective study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | University of Michigan, Ann Arbor, MI | Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy. No interventions were included in this retrospective study. |
| BG001 | National Jewish Health, Denver, CO |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Chest Wall Muscle Size | 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). | 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. | Posted | Mean | Standard Deviation | cm2 | 28 months |
|
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Adverse event data was not collected, as this was a retrospective observational study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | University of Michigan, Ann Arbor, MI | Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy. No interventions were included in this retrospective study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Njira Lugogo | University of Michigan | 734-647-6477 | nlugogo@med.umich.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 28, 2020 | Aug 12, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic) |
| pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic) |
| Reduction in Oral Corticosteroid (OCS) | 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. | pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic) |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
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. No interventions were included in this retrospective study. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Age, Customized | Data is the specific breakdown of mean participant age by gender. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Body Mass Index (BMI) | Data is the specific breakdown of mean participant BMI by gender. | Mean | Standard Deviation | kg/m^2 |
|
| Height | Data is the specific breakdown of mean participant height by gender. | Mean | Standard Deviation | centimeters |
|
| Weight | Data is the specific breakdown of mean participant weight by gender. | Mean | Standard Deviation | kilograms |
|
Severe asthma patients treated at Michigan Medicine who are on biologic therapies for asthma and who have CT imaging and known outcomes on therapy.
No interventions were included in this retrospective study.
| OG001 | National Jewish Health, Denver, CO | 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. No interventions were included in this retrospective study. |
|
|
| Primary | Chest Wall Muscle Quality | 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). | 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. | Posted | Mean | Standard Deviation | HU | 28 months |
|
|
|
| Primary | Exacerbation Reduction - Muscle Size | 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. | 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. | Posted | Mean | Standard Deviation | cm2 | 28 months |
|
|
|
|
| Primary | Exacerbation Reduction - Muscle Quality | 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. | 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. | Posted | Mean | Standard Deviation | HU | 28 months |
|
|
|
|
| Primary | Exacerbations | 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. | 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. | Posted | Count of Participants | Participants | pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic) |
|
|
|
| Secondary | FEV1 Improvement | 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. | 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 | Posted | Mean | Standard Deviation | cm2 | pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic) |
|
|
|
| Secondary | Reduction in Oral Corticosteroid (OCS) | 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. | 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 | Posted | Mean | Standard Deviation | cm2 | pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic) |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | National Jewish Health, Denver, CO | 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. No interventions were included in this retrospective study. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Did not have reduction in exacerbations |
|
|
| Other |
Statistical Test of Hypothesis |
| Other |
Statistical Test of Hypothesis |
| Non-Responders |
|
|
| Non-Responders |
|
|