Comparison of Microglial Activation in Severe Asthma and Healthy Controls
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 75 Years
- Sex
- All sexes
- Healthy volunteers
- Accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study looks at how swelling in the airways from asthma affects the brain and may relate to depression and anxiety. It compares adults ages 18–75 who have severe asthma with healthy adults who do not have asthma. Participants have 3 visits for questions, computer tasks, breathing and allergy tests, blood and mucus samples, and brain scans.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Be 18–75 years old.
- Understand the study, agree in writing to join, and be willing and able to follow study steps.
- Have no other health concerns that could affect study results.
- Be able to handle a practice MRI brain scan.
- Have a gene type that allows strong binding to a protein called TSPO. The study leader may also allow a mixed strong/weak binding type.
- If joining the asthma group, have a doctor's asthma diagnosis for at least 6 months before screening.
- If joining the asthma group, meet ATS severe asthma guidelines, use GINA Step 4 or 5 treatment, or take 320 micrograms of budesonide daily. Some approved biologic medicines may be allowed.
Who can't join
- Meet the study's current-smoking rule: more than half a pack weekly for the past 6 months and any smoking within 2 weeks of study tests. A smoking history over 5 pack-years in the past 10 years also rules you out. One pack-year means one pack daily for a year.
- Receive allergy treatment to build tolerance unless the dose is stable; take certain mental health or biologic medicines that could affect results; take scheduled non-selective beta-blockers before visits; or be unable to pause required medicines.
- Have taken an experimental drug within 30 days of joining. The study doctor decides how long you must wait, which may be longer than 30 days.
- Have a fear of needles or tight spaces, cannot safely have an MRI, or cannot follow directions or handle study tests.
- Have had a stroke, mini-stroke, heart attack, heart stent, or sudden loss of blood flow to the heart in the past 6 months. Other major health problems are reviewed by the study doctors.
- Have a long-term infection or another condition that the study doctors believe could affect safety or results.
- Have a past diagnosis of bipolar disorder, schizophrenia, or schizoaffective disorder. A serious head injury or seizure disorder may also rule you out unless the study doctors allow it.
- Be pregnant, breastfeeding, or planning pregnancy during the study.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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
Study sites (1)
WI
- Center for Healthy Minds · Madison, WI 53703Janelle Grogan · Study contact · 608-263-0524 · jegrogan@medicine.wisc.eduMelissa Rosenkranz, PhD · Principal investigatorMore trials in Madison