Innate Immunity and the Allergic Response

Nasal Allergies Clinical Trial

Official title:

Innate Immunity and the Allergic Response

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01494948
• Other study ID #: 221035-2
• Status: Completed
• Phase: N/A
• First received: November 7, 2011
• Last updated: January 7, 2014
• Start date: March 2012
• Est. completion date: March 2013

Study information

• Verified date: January 2014
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Nasal Allergies

Intervention

Other:
• allergen challenge
nasal challenges with antigen to which they are sensitive to

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Medical College of Wisconsin	Merck Sharp & Dohme Corp.

References & Publications (1)

Sigua JA, Buelow B, Cheung DS, Buell E, Hunter D, Klancnik M, Grayson MH. CD49d-expressing neutrophils differentiate atopic from nonatopic individuals. J Allergy Clin Immunol. 2014 Mar;133(3):901-4.e5. doi: 10.1016/j.jaci.2013.09.035. Epub 2013 Dec 18. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase in percentage of CD49d expressing neutrophils in nasal lavage post allergen challenge.	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.	1month	No
Secondary	Change in immune cell numbers in the nasal lavage following allergen challenge	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).	1 month	No