Patterns of Neurocircuitry Activation In Severe Asthma

NCT03230188 | Completed

• 2 other identifiers: 2017-02085R01HL123284-02
• Study Type: observational
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Diseases

Keywords

asthma; neurocircuitry; severe asthma; mild to moderate asthma; neurocircuitry patterns

Outcome Measures

Primary Outcomes (1)

• Measures of Neural Activity

  % signal change in brain insula detected by functional Magnetic Resonance Imaging

  Visit 1 (1 day)

Secondary Outcomes (5)

• Airway Cellular and Molecular Inflammatory Response- White Blood Cells

  Visit 1 (1 day)

• Airway Cellular and Molecular Inflammatory Response- Eosinophils

  Visit 1 (1 day)

• Airway Cellular and Molecular Inflammatory Response- Lymphocytes

  Visit 1 (1 day)

• Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages

  Visit 1 (1 day)

• Airway Cellular and Molecular Inflammatory Response- Neutrophils

  Visit 1 (1 day)

Study Arms (1)

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); Other: Cognitive Function Testing (non-diagnostic); Other: Asthma and Psychological Questionnaires (non-diagnostic)

Interventions

functional Magnetic Resonance Imaging (research grade) OTHER

Subjects will undergo a simulated and actual functional Magnetic Resonance Imaging scan.

Severe Asthmatics

Cognitive Function Testing (non-diagnostic) OTHER

Subjects will take non-diagnostic cognitive function tests

Severe Asthmatics

Asthma and Psychological Questionnaires (non-diagnostic) OTHER

Subjects will fill out asthma and psychological questionnaires (non-diagnostic)

Severe Asthmatics

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

UW Madison

Madison, Wisconsin, 53792, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Lung Diseases; Asthma

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• William W Busse, MD

  The University of Wisconsin School of Medicine and Public Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 28, 2017
• First Posted: July 26, 2017
• Study Start: August 1, 2017
• Primary Completion: June 17, 2018
• Study Completion: June 17, 2018
• Last Updated: January 24, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)