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Completed

NCT Number: NCT01494948

Innate Immunity and the Allergic Response

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

allergen challenge

Other

nasal challenges with antigen to which they are sensitive to

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 19, 2011
Registry last updated
Jan 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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