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Completed

NCT Number: NCT03039101

Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects

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).

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal lavage

Procedure

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

Nasal allergen challenge

Procedure

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

Epicutaneous skin testing

Procedure

Skin testing (prick) to determine allergies.

Peripheral blood

Procedure

Peripheral blood draw

Montelukast 10Mg Tablet

Drug

one pill orally, daily, for 1 week

Other names: montelukast

Placebo oral tablet

Drug

one pill orally, daily, for 1 week

Other names: placebo

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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 outcomes

  1. Induction of expression of immunoglobulin E (IgE) receptor on dendritic cells following exposure with CD49d+ cells from peripheral blood samples.

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Mitchell Grayson

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Feb 1, 2017
Registry last updated
Oct 7, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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