Clinical trial NCT06922760: Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts
Official title: Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Asthma
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2025-04-10
Enrollment: 233
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
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).

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.

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

Primary outcomes:
measure: Chest wall muscle size
timeFrame: 18 months
measure: Chest wall muscle quality
timeFrame: 18 months
measure: Linear relationship
timeFrame: 18 months
measure: non-linear relationship
timeFrame: 18 months
measure: Exacerbations
timeFrame: 18 months
Secondary outcomes:
measure: Phenotypes
timeFrame: 18 months
measure: Oral Corticosteroids (OCS) Use
timeFrame: 18 months
Other outcomes:
Locations:
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Njira Lugogo
role: PRINCIPAL_INVESTIGATOR
References: