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Innate Immunity and the Allergic Response

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT01494948
First received: November 7, 2011
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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 Intervention
Nasal Allergies
Other: allergen challenge

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Innate Immunity and the Allergic Response

Resource links provided by NLM:


Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • Increase in percentage of CD49d expressing neutrophils in nasal lavage post allergen challenge. [ Time Frame: 1month ] [ Designated as safety issue: No ]
    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:
  • Change in immune cell numbers in the nasal lavage following allergen challenge [ Time Frame: 1 month ] [ Designated as safety issue: No ]
    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).


Enrollment: 36
Study Start Date: March 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494948

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

Publications:
Responsible Party: Medical College of Wisconsin
ClinicalTrials.gov Identifier: NCT01494948     History of Changes
Other Study ID Numbers: 221035-2
Study First Received: November 7, 2011
Last Updated: January 7, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on November 20, 2014