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Observational Study on Asthma and Brain Function

This study aims to understand how asthma affects brain function and whether airway inflammation in asthma is linked to symptoms of depression and anxiety. Researchers will use PET/MRI scans with a special tracer called [18F]FEPPA. This tracer helps them see 'microglial activation' in the brain, which is a sign of inflammation. You may be able to join if you are 18 to 75 years old and have no health concerns that would affect the study. The study will compare results between people with asthma and those without asthma. The main goal is to measure how much [18F]-FEPPA binds in the brain, which will be checked up to 2 weeks after the scan.

Study design
This is an observational study planning to enroll 100 participants. It compares people with asthma to those without asthma.
What's involved
You would have 3 visits, complete questionnaires and computer tasks, undergo allergy skin and breathing tests, provide two blood samples and one sputum sample, and have brain imaging scans.
Compensation
Not stated in the trial record.
Follow-up
Binding of [18F]-FEPPA will be measured up to 2 weeks after the scan.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06299592

Comparison of Microglial Activation in Severe Asthma and Healthy Controls

Recruiting
Not specifiedAll Ages
Updated 2026-08-26T02:15:47.754948+00:00 on ClinicalTrials.gov

Conditions

Asthma

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Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

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