Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects

Mitchell Grayson25 enrolled

Overview

The purpose of this study is to see if the recruitment of a certain cell type (the alpha 4 integrin (CD49d) expressing neutrophil) during a nasal allergen challenge can be inhibited by pretreatment with an FDA approved leukotriene antagonist (montelukast).

Subjects will be consented, undergo skin testing, medical history questionnaires, and randomized to either placebo or montelukast (10 mg). In one week, subjects return, undergo a blood draw, medical history questionnaires, nasal lavage, and nasal allergen challenge (followed by lavage in 6 hours). Subjects will then cross-over to the other study drug. One week later subjects will undergo a blood draw, medical history questionnaires, lavage, allergen challenge, and repeat lavage (after 6 hours).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Enrollment

Conditions

Nasal Allergy

Interventions

Nasal lavagePROCEDURE

determine frequency of CD49d expressing neutrophils in the nasal lavage by flow cytometry

Nasal allergen challengePROCEDURE

A small amount of allergen extract will be applied to one naris.

Epicutaneous skin testingPROCEDURE

Skin testing (prick) to determine allergies.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * 21 - 65 years of age, inclusive * A personal history of allergic rhinitis (hayfever) (by self-report) * At least one positive skin test to cat, dust mite mix, Timothy grass, Bermuda grass, Bluegrass, or Ragweed * Ability to provide informed consent * Willingness to undergo epicutaneous skin testing * Willingness to undergo nasal lavages and nasal allergen challenges * Willingness to undergo 2 peripheral blood draws (10 cc each) Exclusion Criteria: * Use of systemic antihistamine in the past 5 days * Use of intranasal corticosteroids or intranasal antihistamines currently or in the past 2 weeks * Use of Montelukast currently or in the past week * Hypersensitivity or allergy to Montelukast * Inability to perform/undergo any study procedures * Pregnancy (by subject report) or breastfeeding * Confirmed or suspected immunodeficiency * Persistent asthma, atopic dermatitis, or any other co-morbid disease except for allergic rhinitis * Any symptoms of asthma in the past 2 weeks (shortness of breath, wheezing, and/or use of albuterol) * Fever (temperature over 99F) currently or in the past 2 weeks * Current or previous use of a biologic or investigational agent in the past 6 months * Current or past suicidal thoughts/attempts

Locations (1)

Nationwide Children's Hospital

Columbus, Ohio, United States

Outcomes

Primary Outcomes

Change in frequency in CD49d+ neutrophils in the nasal lavage post-allergen challenge on placebo versus Montelukast.

The primary outcome will be the change in frequency (as assessed by flow cytometry) in CD49d+ neutrophils in the nasal lavage post-allergen challenge on placebo versus Montelukast.

Time frame: 1 month

Secondary Outcomes

Change in clinical response following nasal allergen challenge after one week of treatment with Montelukast.

Secondary outcomes will be whether treatment with Montelukast for one week changes the clinical response to nasal allergen challenge (i.e., sneezing, itching, etc.) as documented in the validated Sino Nasal Outcome Test (SNOT)-20 questionnaire.

Time frame: 1 month

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.