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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

Asthma

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

📊
1 of 100 participants interested
1% interest

See if this study fits

A short prescreen based on this study's listed criteria. A coordinator confirms eligibility — this is not a medical assessment.

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Study locations

Choose your preferred location, or select flexible during enrollment.

RECRUITING

Madison

Wisconsin

Location available

Express your interest

Share your contact details and a study coordinator can follow up about screening.

Secure & Confidential

Your information is protected and will only be shared with the research team.

What participation can include

  • Study-related care provided by the research team
  • Close monitoring by medical professionals
  • Possible compensation for time and travel*
  • The option to withdraw at any time
  • Contributing to medical research that may help future patients

*Compensation varies by study. Confirm details with coordinator.

Typical next steps

  1. 1.Submit this form
  2. 2.Phone screening
  3. 3.In-person assessment if eligible
  4. 4.Begin participation

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Looking for Asthma Treatment in Madison?

Join others in Wisconsin exploring innovative treatment options through clinical research

Asthma Treatment Options in Madison, Wisconsin

If you're searching for Asthma treatment in Madison, participating in a clinical research study may provide access to innovative approaches under expert medical supervision. This study is actively recruiting participants in Madison and surrounding areas.

Clinical trials offer participants the opportunity to receive cutting-edge treatments while contributing to medical research that may help future patients with Asthma. All study-related care is provided at no cost to participants.

Local Sites
1 locations in Wisconsin
Now Enrolling
Up to 100 participants
Quick Start
Screening available now

Why Consider a Clinical Trial for Asthma?

Potential Benefits

  • Access to new treatment approaches before public availability
  • Close monitoring by experienced medical professionals
  • Study-related care provided at no cost
  • Contribute to medical research for Asthma

What to Expect

  • Initial screening to determine eligibility
  • Regular check-ups and monitoring visits
  • Possible compensation for time and travel
  • You can withdraw at any time

Frequently Asked Questions About This Asthma Study

Important Clinical Trial Information

This information is provided for educational purposes and does not constitute medical advice. Clinical trial participation involves potential risks and benefits. Eligibility requirements apply and will be assessed during the screening process.

Study identifier: NCT06299592. For complete study details, visit ClinicalTrials.gov. Always consult with your healthcare provider before making decisions about your medical care or participating in clinical research.