Comparison of Microglial Activation in Severe Asthma and Healthy Controls
MAIA-SC
5 other identifiers
observational
100
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2024
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 29, 2024
CompletedStudy Start
First participant enrolled
March 6, 2024
CompletedFirst Posted
Study publicly available on registry
March 8, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
September 3, 2025
August 1, 2025
4.4 years
February 29, 2024
August 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Up to 2 weeks
Secondary Outcomes (3)
How activated microglia correspond to immune biomarkers in lung and blood
Up to 2 weeks
Relationship between activated microglia and cognitive function
Up to 2 weeks
Relationship between activated microglia and psychological symptoms
Up to 2 weeks
Study Arms (2)
Participants with asthma
Participants without asthma
Interventions
PET/MRI scans with \[18F\]FEPPA radiotracer selective for translocator protein (TSPO) binding, which is elevated in activated microglia
Eligibility Criteria
Adults (age 18-75) with or without severe asthma.
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Center for Healthy Minds
Madison, Wisconsin, 53703, United States
Biospecimen
* Blood * Sputum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Rosenkranz, PhD
University of Wisconsin, Madison
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2024
First Posted
March 8, 2024
Study Start
March 6, 2024
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
September 3, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share