Microglia Activation in Asthma
MAIA
5 other identifiers
observational
50
1 country
1
Brief Summary
The goal of this clinical trail 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 6 visits, participants will:
- Complete questionnaires
- Complete computer tasks
- Undergo allergy skin test
- Undergo breathing tests including two whole lung allergen challenges
- Give four blood samples
- Complete brain imaging scans
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2019
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 17, 2019
CompletedFirst Submitted
Initial submission to the registry
March 10, 2020
CompletedFirst Posted
Study publicly available on registry
March 13, 2020
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
August 26, 2025
August 1, 2025
8.6 years
March 10, 2020
August 19, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Presence of Neuroinflammation measured by TSPO observed via PET scan
The investigators propose that, in subjects with asthma, provocation of airway inflammation activates microglia, indicative of a neuroinflammatory signal. The hypothesis is that microglial activation will occur following an inhaled allergen challenge, relative to pre-challenge. Activation of microglia will be measured using positron emission tomography (PET) with the radiotracer \[18F\]FEPPA, a tracer selective for translocator protein (TSPO) binding, which is elevated in activated microglia.
up to 9 days
Secondary Outcomes (2)
Intensity of Airway Response measured by Fraction of exhaled nitric oxide (FeNO) Level
up to 11 days
Intensity of Airway Response measured by Sputum Eosinophil Count
up to 10 days
Other Outcomes (1)
Functionality Measured by Statistical Significance of Co-variation between Cognitive Tasks or Self-Report Instruments and Microglial Activation
up to 10 days
Interventions
Whole lung antigen challenge with cat hair, house dust mite, or short ragweed allergen extracts.
\[18F\]FEPPA is a radiotracer selective for translocator protein (TSPO) binding, which is elevated in activated microglia.
Eligibility Criteria
Adults (age 18-75) with mild allergic asthma
You may qualify if:
- Individuals with no health concerns that might affect the outcome of the study.
- Age 18-75 years of age.
- 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). Mild asthma will be defined as asthma that is well controlled with low-intensity treatment, e.g., SABA alone, as-needed low-dose ICS-LABA, or low-dose ICS plus as-needed SABA.
- At least a 20% decrease in forced expiratory volume (FEV1) during the immediate response following the screening inhaled allergen challenge.
- FEV1 ≥ 70% predicted at baseline.
- Positive immediate skin test for allergies to cat hair, house dust mite, or ragweed (historical data documented within the last 5 years with our research group is acceptable).
- 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.
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
- Use of psychotropic medication that might affect function of neurocircuitry implicated in the investigator's hypotheses at the discretion of the PI or Co-Investigator (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
- Current use of beta-1 selective blockers (e.g., metoprolol, atenolol, acebutolol, betaxolol, esmolol, bisoprolo, and nebivolol)
- 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 or 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
- +8 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Wisconsin Madison
Madison, Wisconsin, 53703-2637, United States
Biospecimen
* Blood * Sputum
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Melissa Rosenkranz
Center for Healthy Minds
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 10, 2020
First Posted
March 13, 2020
Study Start
December 17, 2019
Primary Completion (Estimated)
August 1, 2028
Study Completion (Estimated)
August 1, 2028
Last Updated
August 26, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share
There is no specific sharing plan at this time except most likely will collaborate with researchers within and outside UW-Madison who would have access to data.