| Criteria: |
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Inclusion Criteria:
- Exposure to mouse on a regular basis through occupation or animal care. Patients must
sign informed consent before completing any study procedure.
- Healthy subjects age >18 years and <60 years
- Females with no child bearing potential. Females are considered not to have child
bearing potential before their menarche, at least 2 years after menopause or if they
have had a total hysterectomy or bilateral oophorectomy
- Females with child bearing potential if they fulfill the following criteria: Use of a
medically accepted contraceptive method (hormone birth control [orally, injectable,
or implant for at least 2 months prior to enrollment], intrauterine device,
spermicide used with a male condom, bilateral tubal ligation, diaphragm with
spermicide, female condom), and have a negative pregnancy test
- Patients who are able to understand the information given, be compliant with the
protocol including investigational product administration and visit schedules as well
as recording information requested by the investigators.
Exclusion Criteria
- Present history of tobacco smoking (within the past 12 months or ex-smoker with >10
pack years).
- Illicit drug use.
- Asthma requiring treatment with medications other than beta-2 inhaled agonists and
leukotriene inhibitors.
- Patients with a history of asthma or wheezing with an FEV1 <80%
- Subjects who have taken a nasal adrenergic agonist the day of the procedure
- Use of H1 antagonists, leukotriene inhibitors, tricyclic antidepressants,
phenothiazines, nasal antihistamines, or ocular antihistamines within 5 days prior to
the testing.
- Subjects who are on nasal, oral steroids, or ketotifen within 2 weeks of the
procedure
- Subjects taking beta blockers, ace inhibitors, continuous systemic corticotherapy,
immunosuppressive drugs, reserpine, clonidine or monoamine oxidase inhibitors.
- Patients who have received any desensitization for mouse allergen in the past 5 years
- Ongoing immunotherapy with any other allergen.
- Patients with any nasal condition that could confound the efficacy or safety
assessments, for example nasal polyposis, nasal ulcers, nasal surgery 6 weeks prior
to study or tumors.
- Patients with any past or current clinically significant condition that may affect
the patient's participation or the outcome of the study to the discretion of the
investigator. These include, but are not limited to, anaphylaxis with
cardio-respiratory symptoms (to any known or unknown source including mice exposure),
chronic urticaria and angioedema unless related to mouse exposure, severe atopic
dermatitis, malignancy, cardiovascular, hepatic, renal, hematological, neurological,
immunological, and endocrine disease.
- Hyper responsiveness to glycerin control on nasal challenge as defined by a
non-cumulative score of 5 on the nasal challenge symptom score.
- Although fetal risk is not expected to be high, women of childbearing potential who
may be pregnant or who are not on adequate contraceptives will be excluded from the
study (as defined in inclusions). In addition pregnant or breastfeeding women will
also be excluded from the study.
- Study staff, investigators, sub-investigators, as well as their children or spouses
and family members of all study staff should not be enrolled in the study. |