RECRUITING

Comparison of Microglial Activation in Severe Asthma and Healthy Controls

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Comparison of Microglial Activation in Severe Asthma and Healthy Controls

Quick Facts

Study Start:2024-03-06

Study Completion:2028-08

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06299592

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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 5 therapy or daily treatment of 640mcg Budesinide. Therapy may include ongoing use of currently approved biologic immunomodulators	* 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 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

Inclusion Criteria

Exclusion 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 5 therapy or daily treatment of 640mcg Budesinide. Therapy may include ongoing use of currently approved biologic immunomodulators

* 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 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

Contacts and Locations

Study Contact

Rachel Kaspari

CONTACT

608-265-6066

rkaspari@medicine.wisc.edu

Liana Larson

CONTACT

608-263-0524

llarson@medicine.wisc.edu

Principal Investigator

Melissa Rosenkranz, PhD

PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Study Locations (Sites)

Center for Healthy Minds

Madison, Wisconsin, 53703

United States

Collaborators and Investigators

Sponsor: University of Wisconsin, Madison

Melissa Rosenkranz, PhD, PRINCIPAL_INVESTIGATOR, University of Wisconsin, Madison

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-03-06

Study Completion Date2028-08

Study Record Updates

Study Start Date2024-03-06

Study Completion Date2028-08

Terms related to this study

Additional Relevant MeSH Terms

Asthma