NCT03039101

Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects

Double Blind Study of Leukotriene Antagonism in the Nasal Recruitment of CD49d Expressing Neutrophils in Atopic Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Mitchell Grayson · Academic / Other
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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).

Conditions

• Nasal Allergy

Interventions

Type	Name	Description
PROCEDURE	Nasal lavage	determine frequency of CD49d expressing neutrophils in the nasal lavage by flow cytometry
PROCEDURE	Nasal allergen challenge	A small amount of allergen extract will be applied to one naris.
PROCEDURE	Epicutaneous skin testing	Skin testing (prick) to determine allergies.
PROCEDURE	Peripheral blood	Peripheral blood draw
DRUG	Montelukast 10Mg Tablet	one pill orally, daily, for 1 week
DRUG	Placebo Oral Tablet	one pill orally, daily, for 1 week

Timeline

• Start date: 2017-09-06
• Primary completion: 2018-07-16
• Completion: 2018-07-16
• First posted: 2017-02-01
• Last updated: 2019-10-07

Locations

1 site across 1 country: United States