Innate Immunity and the Allergic Response

NCT01494948 | Completed

• 1 other identifier: 221035-2
• Study Type: interventional
• Target: 36
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Nasal Allergies

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in immune cell numbers in the nasal lavage following allergen challenge

  1 month

Study Arms (2)

placebo

PLACEBO COMPARATOR

skin test negative

Other: allergen challenge

allergic

ACTIVE COMPARATOR

Skin test positive

Other: allergen challenge

Interventions

allergen challenge OTHER

nasal challenges with antigen to which they are sensitive to

allergic; placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).
• Any prior history of immunodeficiency, cardiac, congenital, diabetes, renal, gastrointestinal, hematologic, or oncologic disease.
• The use of any intranasal and inhaled corticosteroids within the last month.
• Current therapy with any medication other than as needed over-the-counter medications or as-needed (not scheduled) antihistamine use.
• Current pregnancy.
• Women of childbearing potential not using an acceptable birth control method, as well as women who are breastfeeding
• Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)
• Use of any other investigational agent in the last 30 days

Sponsors & Collaborators

• Medical College of Wisconsin: lead
• Merck Sharp & Dohme LLC: collaborator

Related 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. No abstract available.

  PMID: 24360325 RESULT

Study Officials

• Mitchell Grayson, MD

  Medical College of Wisconsin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2011
• First Posted: December 19, 2011
• Study Start: March 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: January 8, 2014

Record last verified: 2014-01