Innate Immunity and the Allergic Response

Not Applicable

Completed

• Conditions: Nasal Allergies
• Interventions: Other: allergen challenge

• Registration Number: NCT01494948
• Lead Sponsor: Medical College of Wisconsin

Brief Summary

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2011-11-07
• Study First Submitted QC: 2011-12-15
• Study First Posted: 2011-12-19
• Study Start: 2012-03
• Primary Completion: 2013-03
• Study Completion: 2013-03
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-07
• Last Update Posted: 2014-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
placebo	allergen challenge	skin test negative
allergic	allergen challenge	Skin test positive

Primary Outcome Measures

Name	Time	Method
Increase in percentage of CD49d expressing neutrophils in nasal lavage post allergen challenge.	1month	Nasal lavage on atopic and non-atopic adult subjects will be performed at baseline and following an allergen challenge. The frequency of CD49d expressing neutrophils in the lavage fluid will be determined by flow cytometry analysis, and the change in this frequency will be correlated with atopic status and allergen challenge. This is an observational study, procedures performed are not intended to impact the outcome of the individual participants.

Secondary Outcome Measures

Name	Time	Method
Change in immune cell numbers in the nasal lavage following allergen challenge	1 month	The numbers of neutrophils, CD49d+ neutrophils, lymphocytes, dendritic cells, and macrophages in the nasal lavage will be determined before and after allergen challenge. The outcome will be correlation of these changes with allergy status and any clinical symptoms of the allergen challenge (i.e., sneezing).