Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts

Completed

• Conditions: Asthma

• Registration Number: NCT06922760
• Lead Sponsor: University of Michigan

Brief 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.

Detailed Description

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.

Study Timeline

• Study Start: 2021-01-15
• Primary Completion: 2024-07-31
• Study Completion: 2024-07-31
• Status Verified: 2025-04
• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-03
• Last Update Submitted: 2025-04-03
• Study First Posted: 2025-04-10
• Last Update Posted: 2025-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 233

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Chest wall muscle quality	18 months	Muscle quality was measured as the 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).
Linear relationship	18 months	determine the strength of the linear relationship between continuous chest wall muscle size/quality and continuous change in exacerbation frequency
non-linear relationship	18 months	determine the strength of the non-linear relationship between continuous chest wall muscle size/quality and continuous change in exacerbation frequency
Exacerbations	18 months	The average number of exacerbations were compared to baseline exacerbations.
Chest wall muscle size	18 months	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).

Secondary Outcome Measures

Name	Time	Method
Phenotypes	18 months	Phenotype categories were used to check if any were associated with improvement in forced expiratory volume in one second (FEV1) when compared to baseline FEV1. FEV1 is a measurement of how much air a person can exhale in one second. 5 phenotype categories were created based on body mass index (BMI), age, participant identifying as female, skeletal muscle area, and skeletal muscle density.
Oral Corticosteroids (OCS) Use	18 months	Phenotype categories were used to determine if any were associated with any reduction in maintenance OCS use when compared to baseline OCS use. 5 phenotype categories were created based on body mass index (BMI), age, participant identifying as female, skeletal muscle area, and skeletal muscle density.

Trial Locations

Locations (2)

National Jewish Health; 🇺🇸 Denver, Colorado, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States