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Trial record 35 of 90 for:    asthma | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

AsthMatic Inflammation and Neurocircuitry Activation (MINA) (MINA)

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ClinicalTrials.gov Identifier: NCT02764437
Recruitment Status : Recruiting
First Posted : May 6, 2016
Last Update Posted : October 16, 2017
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 investigators have identified areas of the brain that are activated in response to disease-related emotional information, following whole lung allergen challenge in asthma. They propose that activity in these central nervous system locations, as measured by fMRI, is associated with the intensity of allergic inflammation, provoked by segmental bronchial challenge, in the absence of significant airflow obstruction. The investigators predict that this relationship will be mediated by changes in expression of genes in the IL-1β/IL-17 pathway.

Condition or disease Intervention/treatment Phase
Allergic Asthma Biological: Whole lung antigen challenge, segmental allergen challenge Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: AsthMatic Inflammation and Neurocircuitry Activation (MINA)
Actual Study Start Date : July 28, 2016
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
Drug Information available for: Cat Hair

Arm Intervention/treatment
MRI-Bronch, PET-WLAC (Stress vs Control)
Subjects will have a functional MRI scan 24 hours before a bronchoscopy with segmental allergen challenge. 48 hours post segmental allergen challenge, the subject will have another MRI and bronchoscopy. 4-6 weeks later, subjects will have a PET scan and whole lung antigen challenge under a stress condition or control condition. 4-6 weeks later, subject will have another PET scan and whole lung antigen challenge under a stress condition or control condition (whatever they did not have the first time).
Biological: Whole lung antigen challenge, segmental allergen challenge
Whole lung antigen challenge with housedust mite, short ragweed or cat hair allergen extracts. Segmental allergen challenge with housedust mite, short ragweed or cat hair allergen extracts.
Other Name: House dust mite, short ragweed, cat hair allergen extracts




Primary Outcome Measures :
  1. Bronchoalveolar Eosinophils pre vs post antigen challenge [ Time Frame: 48 hours ]
    The percent of eosinophils will be measured from the Bronchoalveolar lavage fluid pre segmental allergen challenge and will be measured 48 hours post segmental allergen challenge.


Secondary Outcome Measures :
  1. Sputum Eosinophils pre stress condition vs post stress condition [ Time Frame: 72 hours ]
    The percent of eosinophils will be measured from the sputum fluid pre stress condition and will be measured up to 72 hours later (post stress condition).

  2. Sputum Eosinophils pre control condition vs post control condition [ Time Frame: 72 hours ]
    The percent of eosinophils will be measured from the sputum fluid pre control condition and will be measured up to 72 hours later (post control condition).



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female with no health concerns that might affect the outcome of the study,
  • Physician diagnosis of asthma for at least six months prior to screening,
  • FEV1 > or equal to 70% at baseline AND 12% reversibility OR PC20 response to methacholine < or equal to 8.0 mg/ml.
  • Skin test positive to house dust mite (D. farinae), short ragweed or cat hair
  • Asthma medications consisting of only inhaled short-acting B-agonist taken as needed,
  • At least a 20% decrease in FEV1 during the immediate response following inhaled antigen challenge (historical data up to 5 years old will satisfy this criteria),
  • Safety laboratory assessments within normal ranges (labs to include CBC with differential, PT, PTT and platelet count),
  • Women of child-bearing potential (WCBP) must have a negative urine pregnancy test (urine HCG) within 48 hours of the methacholine challenge, within 48 hours of the inhaled allergen challenge and on the day of the segmental allergen challenge, as well as fMRI and PET scans. WCBP must agree to use a reliable method of birth control for the duration of the study (reliable methods of birth control can include abstinence, barrier methods, oral contraceptives, injection contraceptives or skin absorption contraceptives).
  • In the opinion of the investigator, capable and willing to grant written informed consent and cooperate with study procedures and requirements.
  • Ability to tolerate a simulated fMRI and PET brain scanning session, and
  • Ability to give valid informed consent to participate by signing and dating a written consent form.

Exclusion Criteria:

  • Psychotropic medication use that might affect function of neurocircuitry implicated in our hypotheses (at the discretion of the PI),
  • Needle phobia or claustrophobia,
  • Unable to distinguish colors used in Stroop task,
  • Night shift work,
  • Major health problems such as autoimmune disease, heart disease, type I and II diabetes, uncontrolled hypertension or lung diseases other than asthma. The listed health problems are definitive exclusion but decisions regarding major health problems not listed will be based upon the judgment of the investigator,
  • History of a diagnosed Bipolar Disorder, Schizophrenia, or Schizoaffective Disorder,
  • History of serious head trauma or seizure disorder (can be included at the discretion of the PI),
  • No pre-existing chronic infectious disease,
  • Any condition for which, in the opinion of the investigator, transient oxyhemoglobin desaturation is inadvisable,
  • Pregnant or lactating females or has a planned pregnancy during the course of the study,
  • Medication other than for asthma, allergies or contraception (at the discretion of the PI),
  • Inhaled corticosteroids or oral corticosteroids within 1 month of screening,
  • Upper or lower respiratory infection within 1 month of screening,
  • Unstable asthma as indicated by self-report of increased symptoms or increased beta-agonist use over the 2 weeks preceding the screening visit,
  • Currently receiving immunotherapy,
  • Current smokers (defined as smoked within the last year) or a former smoker with a history of >5 pack years,
  • Obesity as defined by a Body Mass Index (BMI) >35 or at the discretion of the principal investigator or co-investigator. Subjects with a BMI between 30 and 35 will be evaluated on a case by case basis by the PI or Co-I to determine eligibility.
  • Use of an investigational drug within 30 days of entering the study. This criteria will be reviewed on a case by case basis by the principal investigator or co-investigator to determine appropriate washout period. Appropriate wash out period may be greater than 30 days depending on the half-life of the investigational drug,
  • History of noncompliance with medical regiments or subjects who are considered unreliable including those with a psychiatric history that, in the opinion of the investigator, may interfere with the conduct of 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): NCT02764437


Contacts
Contact: Danika Klaus, BSN 608-263-0524 drklaus@medicine.wisc.edu
Contact: Gina Crisafi, BS 608-265-4554 gmc@medicine.wisc.edu

Locations
United States, Wisconsin
UW Madison School of Medicine and Public Health Recruiting
Madison, Wisconsin, United States, 53792
Contact: Danika Klaus, BSN    608-263-0524    drklaus@medicine.wisc.edu   
Contact: Gina Crisafi, BS    608-265-4554    gmc@medicine.wisc.edu   
Principal Investigator: William W 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 Busse, MD UW Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT02764437     History of Changes
Other Study ID Numbers: 2016-0021
1R01HL123284-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 6, 2016    Key Record Dates
Last Update Posted: October 16, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Additional relevant MeSH terms:
Inflammation
Pathologic Processes