Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects

Mitchell Grayson

Status: Completed

Conditions: Nasal Allergy

Treatments: Drug: Montelukast 10Mg Tablet; Procedure: Nasal lavage; Drug: Placebo Oral Tablet; Procedure: Peripheral blood; Procedure: Epicutaneous skin testing; Procedure: Nasal allergen challenge

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03039101

IRB16-00842

R01HL087778 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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).

Full description

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).

Enrollment: 25 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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25 participants in 2 patient groups, including a placebo group

Montelukast

Experimental group

Description:

Subjects take 1 montelukast 10mg tablet orally, daily and effect on nasal allergen challenge (based on results of epicutaneous skin testing) induced recruitment of cd49d neutrophils in the peripheral blood and nasal lavage determined at 1 week

Treatment:

Procedure: Nasal allergen challenge

Procedure: Nasal lavage

Procedure: Peripheral blood

Drug: Montelukast 10Mg Tablet

Procedure: Epicutaneous skin testing

Placebo

Placebo Comparator group

Description:

Subjects take 1 placebo oral pill, daily and effect on nasal allergen challenge (based on results of epicutaneous skin testing) induced recruitment of cd49d neutrophils in the peripheral blood and nasal lavage determined at 1 week.

Treatment:

Drug: Placebo Oral Tablet

Procedure: Nasal allergen challenge

Procedure: Nasal lavage

Procedure: Peripheral blood