Clinical trial NCT03230188: Patterns of Neurocircuitry Activation In Severe Asthma
Official title: Patterns of Neurocircuitry Activation In Severe Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Diseases
Keywords: asthma
neurocircuitry
severe asthma
mild to moderate asthma
neurocircuitry patterns
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2017-07-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults ages 18 and older who are currently rolled in the Severe Asthma Research Program III study at the University of Wisconsin-Madison (all subjects have severe asthma)

Brief summary: The overall purpose of the study is to compare the patterns of neurocircuitry activation in severe asthmatics vs. mild to moderate and healthy controls. The Investigators hypothesize that neurocircuitry activation increases with asthma severity, producing different neurocircuitry patterns for severe asthmatics than those of mild to moderate asthmatics or non-asthmatics.

Detailed description: To begin to further address possible relationships of asthma and brain function, the investigators propose the following hypothesis, "patients with defined characteristics of severe asthma will have distinct patterns of persistent neurocircuitry activation. The investigators further propose that the detection of ongoing neurocircuitry activation occurs because of persistent and active airway inflammation in severe asthma. Finally, the investigators propose that the intensity of specific neurocircuitry activation will relate to the severity of underlying asthma.

Eligibility criteria: Inclusion Criteria:

* Currently enrolled in Severe Asthma Research Program III (2012-0571) study
* Has severe asthma
* Is a male or female with no health concerns that might affect the outcome of the study
* Provided a negative urine pregnancy test prior to visit (Females only)
* Capable and willing to grant written informed consent and cooperate with study procedures and requirements (investigator discretion)
* Is able to tolerate a simulated functional Magnetic Resonance Imaging brain scanning session
* Is able to give valid informed consent to participate by signing and dating a written consent form

Exclusion Criteria:

* Uses psychotropic medication that might affect function of neurocircuitry implicated in our hypotheses (at the discretion of a study physician or Co-Investigator)
* Has one or more contraindications for functional Magnetic Resonance Imaging
* Has needle phobia or claustrophobia
* Unable to distinguish specific colors used in Stroop task
* History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder
* Is a pregnant or lactating female
* Has had an upper or lower respiratory infection within 1 month of the visit
* Has unstable asthma as indicated by self-report of increased symptoms or increased beta-agonist use over the 2 weeks preceding the visit
* Is a current smoker (defined as smoked within the last year) or a former smoker with a history of \>5 pack years
* Any condition which, in the opinion of the investigator, might interfere with participation in the study
* Inability or unwillingness to perform required study procedures

Primary outcomes:
measure: Measures of Neural Activity
timeFrame: Visit 1 (1 day)
Secondary outcomes:
measure: Airway Cellular and Molecular Inflammatory Response- White Blood Cells
timeFrame: Visit 1 (1 day)
measure: Airway Cellular and Molecular Inflammatory Response- Eosinophils
timeFrame: Visit 1 (1 day)
measure: Airway Cellular and Molecular Inflammatory Response- Lymphocytes
timeFrame: Visit 1 (1 day)
measure: Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages
timeFrame: Visit 1 (1 day)
measure: Airway Cellular and Molecular Inflammatory Response- Neutrophils
timeFrame: Visit 1 (1 day)
Other outcomes:
Locations:
city: Madison
country: United States
facility: UW Madison
state: Wisconsin
Study officials:
affiliation: The University of Wisconsin School of Medicine and Public Health
name: William W Busse, MD
role: PRINCIPAL_INVESTIGATOR
References: