No Study Drug
Researchers observe your health over time — no experimental treatment is given.
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Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 75
Sex
Any
Study type
Observational
Participants needed
50 (estimated)
Sponsor
University of Wisconsin, Madison · Other
Who this trial is looking for
This trial is looking for adults aged 18-75 with asthma to understand how asthma affects the brain and its relationship with anxiety and depression. Participants will complete questionnaires, breathing tests, and brain scans over six visits.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18-75 years old
I have been diagnosed with asthma for at least six months
I can tolerate a simulated MRI brain scanning session
I have a high-affinity TSPO-binding genotype
I can provide informed consent and cooperate with the study
My asthma is mild and well controlled with low-intensity treatment
I have experienced allergy symptoms related to cats, dust, or ragweed
I have a predicted FEV1 of at least 70% at the start of the trial
You may not be able to join if
I smoke or have a significant smoking history
I have major health issues like heart attack or stroke in the last 6 months
I am currently using psychotropic medication
I have claustrophobia or a needle phobia
I am pregnant or breastfeeding
I have had a severe asthma exacerbation requiring ER visit in the past year
I have a history of serious head trauma or seizure disorder
I am currently undergoing allergen immunotherapy
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 …
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 Locations
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City
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Status
Eligibility Criteria
Inclusion Criteria:
* 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). M…
Inclusion Criteria:
* 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.
* An increase in FEV1 \> 10% predicted after up to 8 puffs of albuterol OR positive methacholine defined as PD20 ≤ 400 mcg. (Historical data that is approved by the investigator is acceptable).
* FEV1 ≥ 75% predicted at screening Visit 0a.FEV1 ≥ 70% predicted at baseline.
* Positive immediate skin test for allergies to cat hair and reports asthma symptoms to cats, house dust mite and reports asthma symptoms to dust, or ragweed and reports asthma symptoms to 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.
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
* 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
* 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
* 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
* Have corrected vision and are not able to wear contacts or see sufficiently well to read without glasses or contacts, as glasses will not fit in the PET/MR head coil
* Any other medical condition or disease that would impact subject safety or data integrity in the opinion of the PIs
* Ever intubated due to asthma and has not had a severe exacerbation requiring an ER visit or hospitalization in the past year.
* Participants with well-controlled asthma at enrollment using ICS for their asthma will undergo a supervised step-down of therapy. This step-down aligns with the 2020 Focused Updates to the Management of Asthma Guidelines: Clinician Guide. Participants who undergo the supervised step-down will be withdrawn unless their asthma remains well-controlled for at least 2 weeks prior to Visit 0a and at least 4 weeks prior to Visit 1 using PRN SABA only. Subjects will be monitored remotely during the supervised step-down. If the subject experiences any of the following during the supervised step-down, they will not be eligible to continue in the MAIA study:
* Use of SABA \> 2 days a week for symptom relief (not for exercise-induced bronchoconstriction)
* PEF \< 80% of baseline PEF for \> 2 days in a row
* Use of systemic corticosteroids for asthma symptoms
* ACQ greater than or equal to 1.5
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