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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03039101

Enrollment

Registered

2017-02-01

Start date

2017-09-06

Completion date

2018-07-16

Last updated

2019-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nasal Allergy

Keywords

allergen, neutrophils, allergy

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).

Interventions

PROCEDURENasal lavage

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

PROCEDURENasal allergen challenge

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

PROCEDUREEpicutaneous skin testing

Skin testing (prick) to determine allergies.

PROCEDUREPeripheral blood

Peripheral blood draw

DRUGMontelukast 10Mg Tablet

one pill orally, daily, for 1 week

DRUGPlacebo Oral Tablet

one pill orally, daily, for 1 week

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

21 Years to 65 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Other

Measure	Time frame	Description
Induction of expression of immunoglobulin E (IgE) receptor on dendritic cells following exposure with CD49d+ cells from peripheral blood samples.	1 month	An additional outcome will be whether CD49d+ neutrophils from peripheral blood can induce increased expression of the IgE receptor (FceRI) on dendritic cells (also isolated from the peripheral blood).

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026