NCT06299592 · University of Wisconsin, Madison
Comparison of Microglial Activation in Severe Asthma and Healthy Controls
(MAIA-SC)
What this study is about
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.
View original scientific description
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.
Interventions
COMBINATION_PRODUCT
PET/MRI using [18F]FEPPA tracer
PET/MRI scans with \[18F\]FEPPA radiotracer selective for translocator protein (TSPO) binding, which is elevated in activated microglia
Primary outcome measures
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Exclusion criteria
- 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.
- 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
Where
- Madison, Wisconsin
Collaborators
National Institute on Aging (NIA)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 1, 2026 · Source of record for eligibility and locations