| Eligibility |
Inclusion Criteria:
Individuals who meet all of the following criteria are eligible for enrollment as study
participants:
1. Participant must be able to understand and provide informed consent.
2. Age between 18 and 50 years.
3. Clinical history of at least one of the following reactions to cat dander or dust
mite:
1. Allergic rhinitis, with one or more of nasal congestion, sneezing, runny nose or
post- nasal drainage,
2. Allergic conjunctivitis, with one or more of ocular itching, tearing or swelling,
or
3. Urticarial reactions to contact with cats.
4. Positive allergen prick test to the allergen causing clinical symptoms. A positive
skin prick test is defined as a wheal sum 3 mm in diameter greater than diluent
control.
5. Negative urine pregnancy test at all visits for female participants of reproductive
potential.
6. Female participants with reproductive potential must agree to use an FDA approved
method of birth control for the duration of the study. A highly effective method of
contraception is defined as one which results in a low failure rate (i.e. less than 1%
per year) when used consistently and correctly and includes, but is not limited to,
abstinence from intercourse with a male partner, monogamous relationship with a
vasectomized partner, male condoms with the use of applied spermicide, intrauterine
devices, and licensed hormonal methods.
7. Life-long absence of cigarette smoking, defined as a lifetime total of less than 10
pack-years and none in the past year.
8. Absence of vaping, inhaling or smoking non-cigarette products in the past year.
In addition to inclusion criteria 1-8 above, allergic asthmatic participants must meet all
of the following criteria:
1. Clinical history of asthma.
2. Asthma severity requiring no more than step 2 therapy (NHLBI Guideline, 2007 Expert
Panel Report-3 (EPR-3), http://www.nhlbi.nih.gov/guidelines/asthma/asthgdln.pdf).
3. Validated asthma control test (ACT) score of > 19 at Screening Visit #1.
4. Able to tolerate a 2-week stoppage of inhaled corticosteroids prior to Screening Visit
#2 and both Study Visits.
5. Baseline forced expiratory volume in 1 second (FEV1) no less than 75% of the predicted
value after bronchodilator administration.
6. Methacholine provocative concentration 20 (PC20) < 16 mg/ml.
In addition to inclusion criteria 1 - 8 above, allergic non-asthmatic control participants
must meet all of the following criteria:
1. Baseline FEV1 no less than 90% of the predicted value.
2. Methacholine PC20 = 16 mg/ml.
Exclusion Criteria:
Individuals who meet any of these criteria are not eligible for enrollment as study
participants:
1. Inability or unwillingness of a participant to give written informed consent or comply
with study protocol.
2. Quantitative skin prick titration with a positive reaction to an allergen
concentration of 0.056 bioequivalent allergy units (BAU) or allergy units (AU) per ml.
3. Other lung diseases, including but not limited to sarcoidosis, bronchiectasis and
active lung infection.
4. History of a respiratory tract infection within 6 weeks of Study Visits #1 and #2.
5. Participant reported current diagnosis or history of diabetes mellitus, congestive
heart failure, ventricular arrhythmias, history of a cerebrovascular accident, renal
failure, history of anaphylaxis, or liver disease.
6. Participant reported history of coagulopathy, thrombocytopenia or pulmonary
hypertension.
7. Intolerance to albuterol, atropine, lidocaine, fentanyl, or midazolam.
8. Laboratory values within 12 weeks prior to Study Visits #1 and #2 that demonstrate:
1. Platelet count less than 80,000/mm3,
2. Prothrombin time (PT) more than 1.5 x upper limit of normal (ULN), or
3. Partial thromboplastin time (PTT) more than 1.5 x ULN.
9. Females of reproductive potential who are documented to be pregnant (based on urine
beta-human chorionic gonadotropin (b-HCG) testing), are sexually active and not using
contraception, are seeking to become pregnant, or who are breast feeding.
10. Current or former use of targeted biological therapy for asthma or allergic disorders
including but not limited to benralizumab, dupilumab, mepolizumab, omalizumab, and
reslizumab.
11. Current or past immunotherapy with cat or dust mite extract.
12. Antibiotic use within 6 weeks of Study Visits #1 and #2.
13. Use of systemic steroids within 4 weeks of any Screening or Study Visit. Participants
may be rescreened after completion of steroid treatment.
14. Current use of beta blockers and monoamine oxidase (MAO) inhibitors.
15. Current use of anti-coagulants including but not limited to apixaban, clopidogrel,
dabigatran, dalteparin, danaparoid, enoxaparin, heparin, rivaroxaban, tinzaparin, and
warfarin.
16. Use of aspirin or NSAIDs and inability to stop these medications for 7 days prior to
Study Visits #1 and #2.
17. Non-English speakers.
18. Current, diagnosed mental illness or current, diagnosed or self-reported drug or
alcohol abuse that, in the opinion of the investigator, would interfere with the
participant's ability to comply with study requirements.
19. Use of investigational drugs within 30 days of participation.
20. Past or current medical problems or findings from physical examination or laboratory
testing that are not listed above, which, in the opinion of the investigator, may pose
additional risks from participation in the study, may interfere with the participant's
ability to comply with study requirements or that may impact the quality or
interpretation of the data obtained from the study.
In addition to exclusion criteria 1-20 above, allergic asthmatic participants who meet any
of these criteria are not eligible for enrollment as study participants:
1. Spontaneous asthmatic episode, defined as a worsening of asthma symptoms requiring an
escalation of short-acting bronchodilators and/or inhaled corticosteroids lasting for
2 days or more, within 6 weeks of Screening Visit #1.
2. Increased use of inhaled corticosteroids within 4 weeks of Screening Visit #1.
3. A history of respiratory failure requiring intubation.
In addition to exclusion criteria 1-20 above, allergic non-asthmatic control participants
who meet any of these criteria are not eligible for enrollment as study participants:
1. History of asthma.
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