N/A
N=233
Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts
Asthma
Bottom Line
View on ClinicalTrials.gov: NCT06922760 ↗Enrolled (actual)
233
Serious AEs
—
Results posted
Nov 2025
Primary outcome: Primary: Chest Wall Muscle Size — 95.49; 97.82; 87.98; 102.86 cm2
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Michigan
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Chest Wall Muscle Size |
95.49; 97.82; 87.98; 102.86 | — |
| PRIMARY Chest Wall Muscle Quality |
36.57; 30.27; 39.18; 28.60 | — |
| PRIMARY Exacerbation Reduction - Muscle Size |
94.3; 99.3 | 0.411 |
| PRIMARY Exacerbation Reduction - Muscle Quality |
37; 29.8 | 0.007 sig |
| PRIMARY Exacerbations |
122; 61; 22; 19 | — |
| SECONDARY FEV1 Improvement |
94.59; 96.93; 88.31; 102.81 | — |
| SECONDARY Reduction in Oral Corticosteroid (OCS) |
91.17; 103.94; 96.09; 97.92 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Asthma diagnosis defined as a positive methacholine test, supportive PFTs, or clinician diagnosis with appropriate supporting clinical context
- Prescribed and taking an FDA-approved biologic medication for severe asthma (mepolizumab, benralizumab, reslizumab, omalizumab, or dupilumab)
- Chest computerized tomography (CT) images taken for any clinical purpose
Exclusion Criteria
- 10-year history of smoking
- Evidence of emphysema on CT imaging
- Severe bronchiectasis secondary to other causes (subjects with scattered bronchiectasis secondary to severe asthma will not excluded)
- 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
Data sourced from ClinicalTrials.gov (NCT06922760). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.