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

NCT06922760 | Completed Results

• 1 other identifier: HUM00140217
• Study Type: observational
• Target: 233
• Locations: 1 country
• Sites: 2

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (5)

• 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.

  pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)

Secondary Outcomes (2)

• FEV1 Improvement

  pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)

• Reduction in Oral Corticosteroid (OCS)

  pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (2)

National Jewish Health

Denver, Colorado, 80206, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Njira Lugogo
• Organization: University of Michigan

nlugogo@med.umich.edu

734-647-6477

Study Officials

• Njira Lugogo

  University of Michigan

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Internal Medicine

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 10, 2025
• Study Start: January 15, 2021
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: November 18, 2025
• Results First Posted: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)