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Patterns of Neurocircuitry Activation In Severe Asthma (PANISA)

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ClinicalTrials.gov Identifier: NCT03230188
Recruitment Status : Recruiting
First Posted : July 26, 2017
Last Update Posted : August 22, 2018
Sponsor:
Collaborators:
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.

Condition or disease Intervention/treatment
Lung Diseases 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
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patterns of Neurocircuitry Activation In Severe Asthma
Actual Study Start Date : August 1, 2017
Estimated Primary Completion Date : January 31, 2019
Estimated Study Completion Date : January 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

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)




Primary Outcome Measures :
  1. Measures of Neural Activity [ Time Frame: Visit 1 (1 day) ]
    % signal change in brain insula detected by functional Magnetic Resonance Imaging


Secondary Outcome Measures :
  1. Airway Cellular and Molecular Inflammatory Response- White Blood Cells [ Time Frame: Visit 1 (1 day) ]
    Cell differential counts- Total White Blood Cell count (sum of absolute counts for: Eosinophils, Monocytes, Neutrophils, Basophils, Lymphocytes)

  2. Airway Cellular and Molecular Inflammatory Response- Eosinophils [ Time Frame: Visit 1 (1 day) ]
    Cell differential counts- Eosinophils

  3. Airway Cellular and Molecular Inflammatory Response- Lymphocytes [ Time Frame: Visit 1 (1 day) ]
    Cell differential counts- Lymphocytes (absolute lymphocyte count, percent lymphocytes)

  4. Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages [ Time Frame: Visit 1 (1 day) ]
    Cell differential counts- Monocytes/Macrophages (absolute monocyte count, percent monocytes)

  5. Airway Cellular and Molecular Inflammatory Response- Neutrophils [ Time Frame: Visit 1 (1 day) ]
    Cell differential counts- Neutrophils (absolute neutrophil count, percent neutrophils)


Biospecimen Retention:   Samples Without DNA
Blood


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03230188


Contacts
Contact: Tina M Palas, BS 608-265-4554 tmp@medicine.wisc.edu
Contact: Jeni A Nestler, BS 608-262-4233 jnestler@medicine.wisc.edu

Locations
United States, Wisconsin
UW Madison Recruiting
Madison, Wisconsin, United States, 53792
Contact: Jeni A Nestler, BS    608-262-4233    jnestler@medicine.wisc.edu   
Contact: Tina M Palas, BS    608-265-4554    tmp@medicine.wisc.edu   
Principal Investigator: William Busse, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: William W Busse, MD The University of Wisconsin School of Medicine and Public Health
  Study Documents (Full-Text)

Documents provided by University of Wisconsin, Madison:

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT03230188     History of Changes
Other Study ID Numbers: 2017-0208
5R01HL123284-02 ( U.S. NIH Grant/Contract )
First Posted: July 26, 2017    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Wisconsin, Madison:
asthma
neurocircuitry
severe asthma
mild to moderate asthma
neurocircuitry patterns

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases