Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects

October 3, 2019 updated by: Mitchell Grayson

Double Blind Study of Leukotriene Antagonism in the Nasal 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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43205
        • Nationwide Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Montelukast
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
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
Other Names:
  • montelukast
PLACEBO_COMPARATOR: Placebo
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.
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: Peripheral blood
Peripheral blood draw
Drug: Placebo Oral Tablet
one pill orally, daily, for 1 week
Other Names:
  • placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mitchell Grayson

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

  • Principal Investigator: Mitchell H Grayson, MD, Nationwide Children's Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 6, 2017

Primary Completion (ACTUAL)

July 16, 2018

Study Completion (ACTUAL)

July 16, 2018

Study Registration Dates

First Submitted

January 26, 2017

First Submitted That Met QC Criteria

January 30, 2017

First Posted (ESTIMATE)

February 1, 2017

Study Record Updates

Last Update Posted (ACTUAL)

October 7, 2019

Last Update Submitted That Met QC Criteria

October 3, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB16-00842
  • R01HL087778 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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