Patterns of Neurocircuitry Activation In Severe Asthma

Lung Diseases Clinical Trial

— PANISA  

Official title:

Patterns of Neurocircuitry Activation In Severe Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03230188
• Other study ID #: 2017-0208
• Secondary ID: 5R01HL123284-02
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: June 17, 2018

Study information

• Verified date: January 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: June 17, 2018
• Est. primary completion date: June 17, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Lung Diseases

Intervention

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

Locations

Country	Name	City	State
United States	UW Madison	Madison	Wisconsin

Sponsors (3)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Heart, Lung, and Blood Institute (NHLBI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measures of Neural Activity	% signal change in brain insula detected by functional Magnetic Resonance Imaging	Visit 1 (1 day)
Secondary	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)
Secondary	Airway Cellular and Molecular Inflammatory Response- Eosinophils	Cell differential counts- Eosinophils	Visit 1 (1 day)
Secondary	Airway Cellular and Molecular Inflammatory Response- Lymphocytes	Cell differential counts- Lymphocytes (absolute lymphocyte count, percent lymphocytes)	Visit 1 (1 day)
Secondary	Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages	Cell differential counts- Monocytes/Macrophages (absolute monocyte count, percent monocytes)	Visit 1 (1 day)
Secondary	Airway Cellular and Molecular Inflammatory Response- Neutrophils	Cell differential counts- Neutrophils (absolute neutrophil count, percent neutrophils)	Visit 1 (1 day)