Innate Immunity and the Allergic Response

Medical College of Wisconsin

Status: Completed

Conditions: Nasal Allergies

Treatments: Other: allergen challenge

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01494948

221035-2

Details and patient eligibility

About

The purpose of this study is to determine if a certain cell type (the CD49d+ neutrophil) is associated with the presence or development of allergic disease.

Full description

A specific subset of neutrophils (CD49d+) will be recruited to the nasal tissue of individuals with allergic disease, and that these cells will also be found in the peripheral blood of allergic subjects. Normal subjects (those without atopy) and those treated for atopic disease will lack the presence of these cells.

Enrollment: 36 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Must give written informed consent before any study related activity is performed
2. Male and female adult and adolescent patients aged ≥18 years and ≤ 65 years.
3. Allergic or non-allergic subjects as proven by allergy skin tests in the past 2 years.

Exclusion criteria

1. The presence of any of these diseases: Atopic dermatitis, persistent controlled asthma, any level of severity of uncontrolled asthma, immunodeficiency or suspected immunodeficiency, any co-morbid disease (cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, and oncologic).
2. Any prior history of immunodeficiency, cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, or oncologic disease.
3. The use of any intranasal and inhaled corticosteroids within the last month.
4. Current therapy with any medication other than as needed over-the-counter medications or as-needed (not scheduled) antihistamine use.
5. Current pregnancy.
6. Women of childbearing potential not using an acceptable birth control method, as well as women who are breastfeeding
7. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
8. Use of any other investigational agent in the last 30 days

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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36 participants in 2 patient groups, including a placebo group

placebo

Placebo Comparator group

Description:

skin test negative

Treatment:

Other: allergen challenge

allergic

Active Comparator group

Description:

Skin test positive

Treatment:

Other: allergen challenge