AsthmaMAIA-SCNCT06299592
Comparison of Microglial Activation in Severe Asthma and Healthy Controls
An observational study of Asthma, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this clinical trial is to learn about how asthma influences brain function. The main questions it aims to answer are: How airway inflammation in asthma affects the brain; and, Whether airway inflammation in asthma is related to symptoms of depression and anxiety Over the course of 3 visits, participants… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- PET/MRI using [18F]FEPPA tracer
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2024to Aug 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adults (age 18-75) with or without severe asthma.
Who may be able to join
- Ability to understand and the willingness to sign a written informed consent document
- Individuals with no health concerns that might affect the outcome of the study
- Age 18-75 years of age
- Ability to tolerate a simulated MRI brain scanning session
- In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements
- High-affinity TSPO-binding genotype. Mixed (high/low) binding-affinity genotype may be included at PIs discretion
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- For participants with severe asthma:
- Physician diagnosis of asthma for at least six months prior to screening (can be determined at the discretion of an asthma/allergy physician member of the study team)
- Severe asthmatics must meet the ATS definition of severe asthma and/or be currently receiving a GINA Step 4 or 5 therapy or daily treatment of 320mcg budesonide. Therapy may include ongoing use of currently approved biologic immunomodulators
Who cannot join
- Current smoker (defined as more than 0.5 pack per week for the past 6 months and any smoking within two weeks of study procedures) or has a smoking history exceeding 5 pack years within the last 10 years
- Currently receiving allergen immunotherapy unless on stable dose.
- Use of psychotropic medication that might affect function of neurocircuitry implicated in our hypotheses (at the discretion of the PI/Co-I)
- Inability to hold medications detailed in the medication hold schedule
- Needle phobia or claustrophobia
- Major health problems such any of the following in the last 6 months: stroke/TIA, myocardial Infarction, stent placement, or acute coronary syndrome are definitively exclusionary. Decisions regarding other major health problems, such as autoimmune disease, history of carotid stenosis, heart disease, uncontrolled hypertension, lung diseases other than asthma, history of significant arrhythmias, etc. will be based upon the judgement of the PI/Co-I.
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- Use of biologic medication that might affect signaling pathways under investigation (at the discretion of the PI/Co-I)
- Pre-existing chronic infectious disease
- Scheduled use of non-selective beta-blockers prior to each study visit.
- Use of an investigational drug within 30 days of entering the study. This criterion will be reviewed on a case by case basis by the PI/Co-I to determine appropriate washout period. Appropriate wash out period may be greater than 30 days depending on the half-life of the investigational drug. Participants may be eligible for study participation after completing the washout period designated by the PI or Co-I (physician only).
- Any MRI incompatibility as determined by most current MRI screening form
- History of a diagnosed bipolar disorder, schizophrenia, or schizoaffective disorder
- History of serious head trauma or seizure disorder (can be included at the discretion of the PI or Co-I)
- Unable, in the judgement of the investigator, to comply with directions and/or tolerate the procedures required for participation in this study
- Pregnant or breast-feeding or has a planned pregnancy during the course of the study
- Any other medical condition or disease that would impact participant safety or data integrity in the opinion of the PI/CO-I
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Center for Healthy Minds
Madison, Wisconsin, 53703
Janelle Grogan, 608-263-0524, jegrogan@medicine.wisc.edu
Melissa Rosenkranz, PhD
About this study
The goal of this clinical trial is to learn about how asthma influences brain function. The main questions it aims to answer are:
- How airway inflammation in asthma affects the brain; and,
- Whether airway inflammation in asthma is related to symptoms of depression and anxiety
Over the course of 3 visits, participants will:
- Complete questionnaires
- Complete computer tasks
- Undergo allergy skin test and breathing tests
- Give two blood samples
- Give a sputum sample
- Complete brain imaging scans
Researchers will compare results between participants with asthma, and participants who do not have asthma.
- Conditions
- Asthma
- Being tested
- PET/MRI using [18F]FEPPA tracer
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PET/MRI using [18F]FEPPA tracerCombination product
PET/MRI scans with [18F]FEPPA radiotracer selective for translocator protein (TSPO) binding, which is elevated in activated microglia
| Study group | Role | What they receive |
|---|---|---|
| Participants with asthma | Not described Receives: Combination Product: PET/MRI using [18F]FEPPA tracer | |
| Participants without asthma | Not described Receives: Combination Product: PET/MRI using [18F]FEPPA tracer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binding of [18F]-FEPPA
A whole-brain voxel-wise t-test will be performed in FMRIB Software Library (FSL) to identify regions where [18F]-FEPPA binding is significantly different between groups.
Measured: Up to 2 weeks
Secondary outcomes (3)
How activated microglia correspond to immune biomarkers in lung and blood
Whole-brain voxel-wise regressions in FSL will test the relationship between [18F]-FEPPA binding and cytokine levels
Measured: Up to 2 weeks
Relationship between activated microglia and cognitive function
whole-brain voxel-wise regressions in FSL will test the relationship between [18F]-FEPPA binding and cognitive function
Measured: Up to 2 weeks
Relationship between activated microglia and psychological symptoms
whole-brain voxel-wise regressions in FSL will test the relationship between [18F]-FEPPA binding and psychological symptoms
Measured: Up to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start6 Mar 2024
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Melissa Rosenkranz, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06299592
- Sponsor's protocol ID
- 2023-1626
- Other IDs
- 1RF1AG082215-01, 4R01AG082215-02, A538900, SMPH/PSYCHIATRY/PSYCHIATRY, Protocol Version 4/22/2026
- Acronym
- MAIA-SC
- Status last verified
- May 2026
- First submitted
- 29 Feb 2024
- Last updated
- 5 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Microglial Activation in Severe Asthma and Healthy Controls
- ClinicalTrials.gov ID
- NCT06299592
- Acronym / sponsor ID
- MAIA-SC / 2023-1626
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 6 Mar 2024 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn about how asthma influences brain function. The main questions it aims to answer are:
- How airway inflammation in asthma affects the brain; and,
- Whether airway inflammation in asthma is related to symptoms of depression and anxiety
Over the course of 3 visits, participants will:
- Complete questionnaires
- Complete computer tasks
- Undergo allergy skin test and breathing tests
- Give two blood samples
- Give a sputum sample
- Complete brain imaging scans
Researchers will compare results between participants with asthma, and participants who do not have asthma.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with asthma | – | Combination Product: PET/MRI using [18F]FEPPA tracer |
| Participants without asthma | – | Combination Product: PET/MRI using [18F]FEPPA tracer |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adults (age 18-75) with or without severe asthma.
Key inclusion criteria (9 listed)
- Ability to understand and the willingness to sign a written informed consent document
- Individuals with no health concerns that might affect the outcome of the study
- Age 18-75 years of age
- Ability to tolerate a simulated MRI brain scanning session
- In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements
Key exclusion criteria (16 listed)
- Current smoker (defined as more than 0.5 pack per week for the past 6 months and any smoking within two weeks of study procedures) or has a smoking history exceeding 5 pack years within the last 10 years
- Currently receiving allergen immunotherapy unless on stable dose.
- Use of psychotropic medication that might affect function of neurocircuitry implicated in our hypotheses (at the discretion of the PI/Co-I)
- Inability to hold medications detailed in the medication hold schedule
- Needle phobia or claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PET/MRI using [18F]FEPPA tracerPET/MRI scans with [18F]FEPPA radiotracer selective for translocator protein (TSPO) binding, which is elevated in activated microglia | Combination product | Participants with asthma, Participants without asthma |
Primary outcome
Binding of [18F]-FEPPA
Time frame: Up to 2 weeks
A whole-brain voxel-wise t-test will be performed in FMRIB Software Library (FSL) to identify regions where [18F]-FEPPA binding is significantly different between groups.
3 secondary outcomes
How activated microglia correspond to immune biomarkers in lung and blood
Time frame: Up to 2 weeks
Relationship between activated microglia and cognitive function
Time frame: Up to 2 weeks
Relationship between activated microglia and psychological symptoms
Time frame: Up to 2 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2026.
- 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.
Melissa Rosenkranz, PhD principal investigator
University of Wisconsin, Madison
1 site 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 Wisconsin, Madison at 1 site 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 9 inclusion and 16 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: looking for participants now, as of the sponsor's last update on 5 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rachel Kaspari (608-263-0524, maia@medicine.wisc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Binding of [18F]-FEPPA (time frame: Up to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Aug 2026.