Innate Immunity and the Allergic Response

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01494948
Recruitment Status : Completed
First Posted : December 19, 2011
Last Update Posted : January 8, 2014
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Nasal Allergies Other: allergen challenge Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Innate Immunity and the Allergic Response
Study Start Date : March 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Arm Intervention/treatment
Placebo Comparator: placebo
skin test negative
Other: allergen challenge
nasal challenges with antigen to which they are sensitive to
Active Comparator: allergic
Skin test positive
Other: allergen challenge
nasal challenges with antigen to which they are sensitive to

Primary Outcome Measures :
  1. Increase in percentage of CD49d expressing neutrophils in nasal lavage post allergen challenge. [ Time Frame: 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 :
  1. Change in immune cell numbers in the nasal lavage following allergen challenge [ Time Frame: 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).

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01494948

Sponsors and Collaborators
Medical College of Wisconsin
Merck Sharp & Dohme Corp.
Principal Investigator: Mitchell Grayson, MD Medical College of Wisconsin

Publications of Results:
Responsible Party: Medical College of Wisconsin Identifier: NCT01494948     History of Changes
Other Study ID Numbers: 221035-2
First Posted: December 19, 2011    Key Record Dates
Last Update Posted: January 8, 2014
Last Verified: January 2014