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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01HL123284-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| functional Magnetic Resonance Imaging (research grade) | Other | Subjects will undergo a simulated and actual functional Magnetic Resonance Imaging scan. |
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| Measure | Description | Time Frame |
|---|---|---|
| Measures of Neural Activity | % signal change in brain insula detected by functional Magnetic Resonance Imaging | Visit 1 (1 day) |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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)
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| Name | Affiliation | Role |
|---|---|---|
| William W Busse, MD | The University of Wisconsin School of Medicine and Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UW Madison | Madison | Wisconsin | 53792 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2018 | May 9, 2018 | Prot_SAP_003.pdf |
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| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D001249 | Asthma |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D001982 | Bronchial Diseases |
| D008173 | Lung Diseases, Obstructive |
| D012130 | Respiratory Hypersensitivity |
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Blood
| Cognitive Function Testing (non-diagnostic) | Other | Subjects will take non-diagnostic cognitive function tests |
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| Asthma and Psychological Questionnaires (non-diagnostic) | Other | Subjects will fill out asthma and psychological questionnaires (non-diagnostic) |
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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) |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |