Patterns of Neurocircuitry Activation In Severe Asthma (PANISA)

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.

Study Overview

• Status: Completed
• Conditions: Lung Diseases
• Intervention / Treatment: Other: functional Magnetic Resonance Imaging (research grade); Other: Cognitive Function Testing (non-diagnostic); Other: Asthma and Psychological Questionnaires (non-diagnostic)

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.

• Study Type: Observational
• Enrollment (Actual): 28

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW Madison

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Severe Asthmatics; Individuals with severe asthma that are already enrolled in the University of Wisconsin Severe Asthma Research Program III study will fill out asthma and psychological questionnaires (non-diagnostic), will undergo Cognitive Function Testing (non-diagnostic), and will undergo a simulated and actual functional Magnetic Resonance Imaging (research grade) scan.

Other: functional Magnetic Resonance Imaging (research grade); Subjects will undergo a simulated and actual functional Magnetic Resonance Imaging scan.; Other: Cognitive Function Testing (non-diagnostic); Subjects will take non-diagnostic cognitive function tests; Other: Asthma and Psychological Questionnaires (non-diagnostic); Subjects will fill out asthma and psychological questionnaires (non-diagnostic)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measures of Neural Activity	% signal change in brain insula detected by functional Magnetic Resonance Imaging	Visit 1 (1 day)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Airway Cellular and Molecular Inflammatory Response- White Blood Cells	Cell differential counts- Total White Blood Cell count (sum of absolute counts for: Eosinophils, Monocytes, Neutrophils, Basophils, Lymphocytes)	Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Eosinophils	Cell differential counts- Eosinophils	Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Lymphocytes	Cell differential counts- Lymphocytes (absolute lymphocyte count, percent lymphocytes)	Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages	Cell differential counts- Monocytes/Macrophages (absolute monocyte count, percent monocytes)	Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Neutrophils	Cell differential counts- Neutrophils (absolute neutrophil count, percent neutrophils)	Visit 1 (1 day)

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: William W Busse, MD, The University of Wisconsin School of Medicine and Public Health

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): June 17, 2018
• Study Completion (Actual): June 17, 2018

Study Registration Dates

• First Submitted: June 28, 2017
• First Submitted That Met QC Criteria: July 24, 2017
• First Posted (Actual): July 26, 2017

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 22, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: asthma; severe asthma; mild to moderate asthma; neurocircuitry; neurocircuitry patterns
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Lung Diseases; Asthma
• Other Study ID Numbers: 2017-0208; 5R01HL123284-02 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No