Comparison of Microglial Activation in Severe Asthma and Healthy Controls (NCT06299592) | Clinical Trial Compass
RecruitingNot Applicable
Comparison of Microglial Activation in Severe Asthma and Healthy Controls
United States100 participantsStarted 2024-03-06
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 sche…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.