AsthmaNCT06922760

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

An observational study of Asthma, run by University of Michigan at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Asthma
How many people: 233 participants
Where: 2 sitesUnited States
Study dates: 15 Jan 2021to 31 Jul 2024
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

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).

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Michigan
Ann Arbor, Michigan, 48109
National Jewish Health
Denver, Colorado, 80206

Other trials in United States

About this study

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.

Read the 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.

Conditions: Asthma
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06922760
Study group	Role	What they receive
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (2)

FEV1 Improvement
Muscle size was used to investigate body composition measures associated with a 5% or greater improvement in forced expiratory volume in one second (FEV1). 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 participants who had and did not have improvement in FEV1. Participants with ≥5% improvement in FEV1 during the 4 to 18-month period following initiation of biologics were classified as responders. Any participant who did not achieve a ≥5% improvement from baseline in that timeframe was classified as a non-responder.
Measured: pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)
Reduction in Oral Corticosteroid (OCS)
Muscle size was used to investigate body composition measures associated with any reduction in maintenance OCS use when compared to baseline OCS use. Subjects with any OCS reduction in use during the 4- to 18-month period following initiation of biologics were classified as responders.
Measured: pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 202131 Jul 2024

First posted10 Apr 2025
Study start15 Jan 2021
Primary completion31 Jul 2024
Study completion31 Jul 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AsthmaStudies of the same condition, open and under way.
More trials run by University of MichiganThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Retrospective
Enrolment: 233 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06922760
Sponsor's protocol ID: HUM00140217
Status last verified: Nov 2025
First submitted: 3 Apr 2025
Last updated: 18 Nov 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts
ClinicalTrials.gov ID: NCT06922760
Acronym / sponsor ID: HUM00140217
Conditions: Asthma
Study type: Observational
Recruitment status: Completed
Enrolment: 233 participants (actual)
Lead sponsor: University of MichiganUniversity, hospital or other
Study start: 15 Jan 2021 (actual)
Primary completion: 31 Jul 2024 (actual)
Study completion: 31 Jul 2024 (actual)
First posted: 10 Apr 2025 (actual)
Results: Posted 18 Nov 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Cohort
Time perspective: Retrospective
Number of arms: 2

Arm	Type	Receives
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.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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).

Key inclusion criteria (3 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Chest Wall Muscle Size
Time frame: 28 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).
Chest Wall Muscle Quality
Time frame: 28 months
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).
Exacerbation Reduction - Muscle Size
Time frame: 28 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 assess whether skeletal muscle size area could be used to predict exacerbation frequency. Results reflect the average muscle sizes when frequency could be predicted.
Exacerbation Reduction - Muscle Quality
Time frame: 28 months
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.
Exacerbations
Time frame: pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)
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.

2 secondary outcomes

FEV1 Improvement
Time frame: pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)
Reduction in Oral Corticosteroid (OCS)
Time frame: pre-biologic at baseline (looking back 1 year), post-biologic (4-18 months after biologic)

Results and safety

Results posted to the registry on 18 Nov 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
University of Michigan, Ann Arbor, MI	152	152
National Jewish Health, Denver, CO	81	81

Primary outcome: Chest Wall Muscle Size

Time frame: 28 months. Mean (Standard Deviation). Unit: cm2

Measure	University of Michigan, Ann Arbor, MI n = 144	National Jewish Health, Denver, CO n = 61
Had reduction in exacerbations	95.49 (25.63)	97.82 (29.04)
Did not have reduction in exacerbations	87.98 (23.65)	102.86 (28.77)

Population analysed: 8 participants in the University of Michigan arm and 1 participant in the National Jewish Health arm did not have either a baseline or post-treatment count of exacerbations so the outcome could not be computed for them. In addition, 20 participants in the National Jewish Health arm (including the 1 without complete outcome data) did not have complete skeletal muscle visible within the scan field, so muscle size and quality could not be adequately assessed.

Primary outcome: Chest Wall Muscle Quality

Time frame: 28 months. Mean (Standard Deviation). Unit: HU

Measure	University of Michigan, Ann Arbor, MI n = 144	National Jewish Health, Denver, CO n = 61
Had a reduction in exacerbations	36.57 (7.94)	30.27 (7.28)
Did not have reduction in exacerbations	39.18 (6.96)	28.60 (6.43)

Primary outcome: Exacerbation Reduction - Muscle Size

Time frame: 28 months. Mean (Standard Deviation). Unit: cm2

Measure	University of Michigan, Ann Arbor, MI n = 144	National Jewish Health, Denver, CO n = 61
Value	94.3 (25.4)	99.3 (28.8)

University of Michigan, Ann Arbor, MI: p = 0.411, Regression, Linear
National Jewish Health, Denver, CO: p = 0.161, Regression, Linear

Primary outcome: Exacerbation Reduction - Muscle Quality

Time frame: 28 months. Mean (Standard Deviation). Unit: HU

Measure	University of Michigan, Ann Arbor, MI n = 144	National Jewish Health, Denver, CO n = 61
Value	37 (7.8)	29.8 (7)

University of Michigan, Ann Arbor, MI: p = 0.007, Regression, Linear
National Jewish Health, Denver, CO: p = 0.5, Regression, Linear

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
University of Michigan, Ann Arbor, MI	0 of 0	0 of 0	0
National Jewish Health, Denver, CO	0 of 0	0 of 0	0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Njira Lugogo principal investigator

University of Michigan

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Asthma, run by University of Michigan at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Nov 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Chest Wall Muscle Size (time frame: 28 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06922760.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.