Lung DiseasesPANISANCT03230188
Patterns of Neurocircuitry Activation In Severe Asthma
An observational study of Lung Diseases, run by University of Wisconsin, Madison at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Diseases
- What is being tested?
- functional Magnetic Resonance Imaging (research grade), Cognitive Function Testing (non-diagnostic) and Asthma and Psychological Questionnaires (non-diagnostic)
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2017to 17 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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)
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Lung Diseases
- Being tested
- functional Magnetic Resonance Imaging (research grade), Cognitive Function Testing (non-diagnostic), Asthma and Psychological Questionnaires (non-diagnostic)
- Keywords
- asthma, neurocircuitry, severe asthma, mild to moderate asthma, neurocircuitry patterns
- Medical subject headings
- Lung Diseases, Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
functional Magnetic Resonance Imaging (research grade)Other
Subjects will undergo a simulated and actual functional Magnetic Resonance Imaging scan.
Cognitive Function Testing (non-diagnostic)Other
Subjects will take non-diagnostic cognitive function tests
Asthma and Psychological Questionnaires (non-diagnostic)Other
Subjects will fill out asthma and psychological questionnaires (non-diagnostic)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: functional Magnetic Resonance Imaging (research grade); Other: Cognitive Function Testing (non-diagnostic); Other: Asthma and Psychological Questionnaires (non-diagnostic) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measures of Neural Activity
% signal change in brain insula detected by functional Magnetic Resonance Imaging
Measured: Visit 1 (1 day)
Secondary outcomes (5)
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)
Measured: Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Eosinophils
Cell differential counts- Eosinophils
Measured: Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Lymphocytes
Cell differential counts- Lymphocytes (absolute lymphocyte count, percent lymphocytes)
Measured: Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages
Cell differential counts- Monocytes/Macrophages (absolute monocyte count, percent monocytes)
Measured: Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Neutrophils
Cell differential counts- Neutrophils (absolute neutrophil count, percent neutrophils)
Measured: Visit 1 (1 day)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2017
- Study start1 Aug 2017
- Primary completion17 Jun 2018
- Study completion17 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung DiseasesStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Sponsor
- Investigators
- William W Busse, MD, Principal investigator, The University of Wisconsin School of Medicine and Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03230188
- Sponsor's protocol ID
- 2017-0208
- Other IDs
- 5R01HL123284-02
- Acronym
- PANISA
- Status last verified
- Jan 2019
- First submitted
- 28 Jun 2017
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patterns of Neurocircuitry Activation In Severe Asthma
- ClinicalTrials.gov ID
- NCT03230188
- Acronym / sponsor ID
- PANISA / 2017-0208
- Conditions
- Lung Diseases
- Keywords
- asthma, neurocircuitry, severe asthma, mild to moderate asthma, neurocircuitry patterns
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 17 Jun 2018 (actual)
- Study completion
- 17 Jun 2018 (actual)
- First posted
- 26 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Severe Asthmatics | – | Other: functional Magnetic Resonance Imaging (research grade), Other: Cognitive Function Testing (non-diagnostic), Other: Asthma and Psychological Questionnaires (non-diagnostic)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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)
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| functional Magnetic Resonance Imaging (research grade)Subjects will undergo a simulated and actual functional Magnetic Resonance Imaging scan. | Other | Severe Asthmatics |
| Cognitive Function Testing (non-diagnostic)Subjects will take non-diagnostic cognitive function tests | Other | Severe Asthmatics |
| Asthma and Psychological Questionnaires (non-diagnostic)Subjects will fill out asthma and psychological questionnaires (non-diagnostic) | Other | Severe Asthmatics |
Primary outcome
Measures of Neural Activity
Time frame: Visit 1 (1 day)
% signal change in brain insula detected by functional Magnetic Resonance Imaging
5 secondary outcomes
Airway Cellular and Molecular Inflammatory Response- White Blood Cells
Time frame: Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Eosinophils
Time frame: Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Lymphocytes
Time frame: Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages
Time frame: Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Neutrophils
Time frame: Visit 1 (1 day)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
William W Busse, MD principal investigator
The University of Wisconsin School of Medicine and Public Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Diseases, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measures of Neural Activity (time frame: Visit 1 (1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.