Status:
COMPLETED
Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts
Lead Sponsor:
University of Michigan
Conditions:
Asthma
Eligibility:
All Genders
18-85 years
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 outcom...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
233 Patients enrolled
Trial Details
Trial ID
NCT06922760
Start Date
January 15 2021
End Date
July 31 2024
Last Update
November 18 2025
Active Locations (2)
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1
National Jewish Health
Denver, Colorado, United States, 80206
2
University of Michigan
Ann Arbor, Michigan, United States, 48109