Trial Outcomes & Findings for Utilizing CT Based Imaging Parameters of Body Composition to Understand Heterogeneity of Response to Biologic Therapies in Severe Asthma Cohorts (NCT NCT06922760)

Last Updated: 2025-11-18

Results Overview

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).

Recruitment status

COMPLETED

Target enrollment

233 participants

Primary outcome timeframe

28 months

Results posted on

2025-11-18

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	152	81
Overall Study COMPLETED	152	81
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Data is the specific breakdown of mean participant age by gender.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	University of Michigan, Ann Arbor, MI n=152 Participants 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 n=81 Participants 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.	Total n=233 Participants Total of all reporting groups
Age, Continuous	52.39 years STANDARD_DEVIATION 14.31 • n=152 Participants	51.75 years STANDARD_DEVIATION 15.58 • n=81 Participants	52.17 years STANDARD_DEVIATION 14.73 • n=233 Participants
Age, Customized Female	51.42 years STANDARD_DEVIATION 13.21 • n=105 Participants • Data is the specific breakdown of mean participant age by gender.	48.08 years STANDARD_DEVIATION 17.86 • n=40 Participants • Data is the specific breakdown of mean participant age by gender.	50.50 years STANDARD_DEVIATION 14.65 • n=145 Participants • Data is the specific breakdown of mean participant age by gender.
Age, Customized Male	54.55 years STANDARD_DEVIATION 16.46 • n=47 Participants • Data is the specific breakdown of mean participant age by gender.	55.34 years STANDARD_DEVIATION 12.15 • n=41 Participants • Data is the specific breakdown of mean participant age by gender.	54.92 years STANDARD_DEVIATION 14.53 • n=88 Participants • Data is the specific breakdown of mean participant age by gender.
Sex: Female, Male Female	105 Participants n=152 Participants	40 Participants n=81 Participants	145 Participants n=233 Participants
Sex: Female, Male Male	47 Participants n=152 Participants	41 Participants n=81 Participants	88 Participants n=233 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=152 Participants	12 Participants n=81 Participants	15 Participants n=233 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	144 Participants n=152 Participants	68 Participants n=81 Participants	212 Participants n=233 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	5 Participants n=152 Participants	1 Participants n=81 Participants	6 Participants n=233 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=152 Participants	0 Participants n=81 Participants	1 Participants n=233 Participants
Race (NIH/OMB) Asian	3 Participants n=152 Participants	0 Participants n=81 Participants	3 Participants n=233 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=152 Participants	0 Participants n=81 Participants	0 Participants n=233 Participants
Race (NIH/OMB) Black or African American	21 Participants n=152 Participants	2 Participants n=81 Participants	23 Participants n=233 Participants
Race (NIH/OMB) White	125 Participants n=152 Participants	69 Participants n=81 Participants	194 Participants n=233 Participants
Race (NIH/OMB) More than one race	0 Participants n=152 Participants	0 Participants n=81 Participants	0 Participants n=233 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=152 Participants	10 Participants n=81 Participants	12 Participants n=233 Participants
Region of Enrollment United States	152 Participants n=152 Participants	81 Participants n=81 Participants	233 Participants n=233 Participants
Body Mass Index (BMI) Female	32.46 kg/m^2 STANDARD_DEVIATION 9.27 • n=105 Participants • Data is the specific breakdown of mean participant BMI by gender.	31.70 kg/m^2 STANDARD_DEVIATION 9.21 • n=40 Participants • Data is the specific breakdown of mean participant BMI by gender.	32.25 kg/m^2 STANDARD_DEVIATION 9.23 • n=145 Participants • Data is the specific breakdown of mean participant BMI by gender.
Body Mass Index (BMI) Male	29.97 kg/m^2 STANDARD_DEVIATION 4.92 • n=47 Participants • Data is the specific breakdown of mean participant BMI by gender.	30.62 kg/m^2 STANDARD_DEVIATION 5.61 • n=41 Participants • Data is the specific breakdown of mean participant BMI by gender.	30.27 kg/m^2 STANDARD_DEVIATION 5.23 • n=88 Participants • Data is the specific breakdown of mean participant BMI by gender.
Height Female	162.31 centimeters STANDARD_DEVIATION 6.78 • n=105 Participants • Data is the specific breakdown of mean participant height by gender.	162.84 centimeters STANDARD_DEVIATION 6.05 • n=40 Participants • Data is the specific breakdown of mean participant height by gender.	162.45 centimeters STANDARD_DEVIATION 6.57 • n=145 Participants • Data is the specific breakdown of mean participant height by gender.
Height Male	176.95 centimeters STANDARD_DEVIATION 6.56 • n=47 Participants • Data is the specific breakdown of mean participant height by gender.	176.59 centimeters STANDARD_DEVIATION 7.78 • n=41 Participants • Data is the specific breakdown of mean participant height by gender.	176.78 centimeters STANDARD_DEVIATION 7.12 • n=88 Participants • Data is the specific breakdown of mean participant height by gender.
Weight Female	85.31 kilograms STANDARD_DEVIATION 23.83 • n=105 Participants • Data is the specific breakdown of mean participant weight by gender.	83.85 kilograms STANDARD_DEVIATION 23.89 • n=40 Participants • Data is the specific breakdown of mean participant weight by gender.	84.91 kilograms STANDARD_DEVIATION 23.77 • n=145 Participants • Data is the specific breakdown of mean participant weight by gender.
Weight Male	93.99 kilograms STANDARD_DEVIATION 16.88 • n=47 Participants • Data is the specific breakdown of mean participant weight by gender.	95.43 kilograms STANDARD_DEVIATION 18.33 • n=41 Participants • Data is the specific breakdown of mean participant weight by gender.	94.66 kilograms STANDARD_DEVIATION 17.48 • n=88 Participants • Data is the specific breakdown of mean participant weight by gender.

PRIMARY outcome

Timeframe: 28 months

Population: 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.

Outcome measures

Outcome measures
Measure	University of Michigan, Ann Arbor, MI n=144 Participants 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 n=61 Participants 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.
Chest Wall Muscle Size Had reduction in exacerbations	95.49 cm2 Standard Deviation 25.63	97.82 cm2 Standard Deviation 29.04
Chest Wall Muscle Size Did not have reduction in exacerbations	87.98 cm2 Standard Deviation 23.65	102.86 cm2 Standard Deviation 28.77

PRIMARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	University of Michigan, Ann Arbor, MI n=144 Participants 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 n=61 Participants 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.
Chest Wall Muscle Quality Had a reduction in exacerbations	36.57 HU Standard Deviation 7.94	30.27 HU Standard Deviation 7.28
Chest Wall Muscle Quality Did not have reduction in exacerbations	39.18 HU Standard Deviation 6.96	28.60 HU Standard Deviation 6.43

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	University of Michigan, Ann Arbor, MI n=144 Participants 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 n=61 Participants 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.
Exacerbation Reduction - Muscle Size	94.3 cm2 Standard Deviation 25.4	99.3 cm2 Standard Deviation 28.8

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	University of Michigan, Ann Arbor, MI n=144 Participants 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 n=61 Participants 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.
Exacerbation Reduction - Muscle Quality	37 HU Standard Deviation 7.8	29.8 HU Standard Deviation 7

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	University of Michigan, Ann Arbor, MI n=144 Participants 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 n=80 Participants 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.
Exacerbations True	122 Participants	61 Participants
Exacerbations False	22 Participants	19 Participants

SECONDARY outcome

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

Population: 48 UM patients and 31 NJ patients that lacked a suitable CT and pre- and post-biologic FEV1 measure were not included in this analysis

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.

Outcome measures

Outcome measures
Measure	University of Michigan, Ann Arbor, MI n=104 Participants 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 n=50 Participants 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.
FEV1 Improvement Responders	94.59 cm2 Standard Deviation 25.06	96.93 cm2 Standard Deviation 32.43
FEV1 Improvement Non-Responders	88.31 cm2 Standard Deviation 23.85	102.81 cm2 Standard Deviation 25.26

SECONDARY outcome

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

Population: 25 UM patients and 20 NJ patients that lacked a suitable CT and pre- and post-biologic OCS maintenance use were not included in this analysis

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.

Outcome measures

Outcome measures
Measure	University of Michigan, Ann Arbor, MI n=127 Participants 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 n=61 Participants 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.
Reduction in Oral Corticosteroid (OCS) Responders	91.17 cm2 Standard Deviation 23.84	103.94 cm2 Standard Deviation 32.96
Reduction in Oral Corticosteroid (OCS) Non-Responders	96.09 cm2 Standard Deviation 26.17	97.92 cm2 Standard Deviation 27.71

Adverse Events

University of Michigan, Ann Arbor, MI

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

National Jewish Health, Denver, CO

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Njira Lugogo

University of Michigan

Phone: 734-647-6477

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place