Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects
- Conditions
- Nasal Allergy
- Interventions
- Procedure: Nasal lavageProcedure: Nasal allergen challengeProcedure: Epicutaneous skin testingProcedure: Peripheral bloodDrug: Placebo Oral Tablet
- Registration Number
- NCT03039101
- Lead Sponsor
- Mitchell Grayson
- Brief Summary
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).
- Detailed 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 25
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Montelukast Nasal lavage 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 Montelukast Nasal allergen challenge 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 Montelukast Epicutaneous skin testing 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 Montelukast Peripheral blood 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 Montelukast Montelukast 10Mg Tablet 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 Placebo Nasal lavage 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. Placebo Nasal allergen challenge 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. Placebo Peripheral blood 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. Placebo Placebo Oral Tablet 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.
- Primary Outcome Measures
Name Time Method Change in frequency in CD49d+ neutrophils in the nasal lavage post-allergen challenge on placebo versus Montelukast. 1 month 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.
- Secondary Outcome Measures
Name Time Method Change in clinical response following nasal allergen challenge after one week of treatment with Montelukast. 1 month 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.
Trial Locations
- Locations (1)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States