AsthMatic Inflammation and Neurocircuitry Activation (MINA)

Completed

Conditions studied: Allergic Asthma

In brief

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.

Key facts

Study ID

NCT02764437

Run by

University of Wisconsin, Madison

People needed

43

Starts

2016-07-28

Expected to finish

2020-03-31

Last updated by the study team

2021-02-16

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 16.0 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.

You may not qualify if…

• 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.

Where it is running

• UW Madison School of Medicine and Public Health — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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