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Patterns of Neurocircuitry Activation In Severe Asthma (PANISA)

22. januar 2019 opdateret af: University of Wisconsin, Madison
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

28

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Wisconsin
      • Madison, Wisconsin, Forenede Stater, 53792
        • UW Madison

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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)

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Measures of Neural Activity
Tidsramme: Visit 1 (1 day)
% signal change in brain insula detected by functional Magnetic Resonance Imaging
Visit 1 (1 day)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Airway Cellular and Molecular Inflammatory Response- White Blood Cells
Tidsramme: Visit 1 (1 day)
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
Tidsramme: Visit 1 (1 day)
Cell differential counts- Eosinophils
Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Lymphocytes
Tidsramme: Visit 1 (1 day)
Cell differential counts- Lymphocytes (absolute lymphocyte count, percent lymphocytes)
Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Monocytes/Macrophages
Tidsramme: Visit 1 (1 day)
Cell differential counts- Monocytes/Macrophages (absolute monocyte count, percent monocytes)
Visit 1 (1 day)
Airway Cellular and Molecular Inflammatory Response- Neutrophils
Tidsramme: Visit 1 (1 day)
Cell differential counts- Neutrophils (absolute neutrophil count, percent neutrophils)
Visit 1 (1 day)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Wisconsin, Madison

Samarbejdspartnere

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Efterforskere

  • Ledende efterforsker: William W Busse, MD, The University of Wisconsin School of Medicine and Public Health

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. august 2017

Primær færdiggørelse (Faktiske)

17. juni 2018

Studieafslutning (Faktiske)

17. juni 2018

Datoer for studieregistrering

Først indsendt

28. juni 2017

Først indsendt, der opfyldte QC-kriterier

24. juli 2017

Først opslået (Faktiske)

26. juli 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

24. januar 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

22. januar 2019

Sidst verificeret

1. januar 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2017-0208
  • 5R01HL123284-02 (U.S. NIH-bevilling/kontrakt)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Kliniske forsøg med functional Magnetic Resonance Imaging (research grade)

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