Leukotriene Antagonism in Recruitment of CD49d Expressing Neutrophils in Atopic Subjects
NCT ID: NCT03039101
Last Updated: 2019-10-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
25 participants
INTERVENTIONAL
2017-09-06
2018-07-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
QUADRUPLE
Study Groups
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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
Nasal lavage
determine frequency of CD49d expressing neutrophils in the nasal lavage by flow cytometry
Nasal allergen challenge
A small amount of allergen extract will be applied to one naris.
Epicutaneous skin testing
Skin testing (prick) to determine allergies.
Peripheral blood
Peripheral blood draw
Montelukast 10Mg Tablet
one pill orally, daily, for 1 week
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.
Nasal lavage
determine frequency of CD49d expressing neutrophils in the nasal lavage by flow cytometry
Nasal allergen challenge
A small amount of allergen extract will be applied to one naris.
Peripheral blood
Peripheral blood draw
Placebo Oral Tablet
one pill orally, daily, for 1 week
Interventions
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Nasal lavage
determine frequency of CD49d expressing neutrophils in the nasal lavage by flow cytometry
Nasal allergen challenge
A small amount of allergen extract will be applied to one naris.
Epicutaneous skin testing
Skin testing (prick) to determine allergies.
Peripheral blood
Peripheral blood draw
Montelukast 10Mg Tablet
one pill orally, daily, for 1 week
Placebo Oral Tablet
one pill orally, daily, for 1 week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
65 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
Mitchell Grayson
OTHER
Responsible Party
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Mitchell Grayson
Principal Investigator
Principal Investigators
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Mitchell H Grayson, MD
Role: PRINCIPAL_INVESTIGATOR
Nationwide Children's Hospital
Locations
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Nationwide Children's Hospital
Columbus, Ohio, United States
Countries
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References
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Sigua JA, Buelow B, Cheung DS, Buell E, Hunter D, Klancnik M, Grayson MH. CD49d-expressing neutrophils differentiate atopic from nonatopic individuals. J Allergy Clin Immunol. 2014 Mar;133(3):901-4.e5. doi: 10.1016/j.jaci.2013.09.035. Epub 2013 Dec 18. No abstract available.
Cheung DS, Ehlenbach SJ, Kitchens RT, Riley DA, Thomas LL, Holtzman MJ, Grayson MH. Cutting edge: CD49d+ neutrophils induce FcepsilonRI expression on lung dendritic cells in a mouse model of postviral asthma. J Immunol. 2010 Nov 1;185(9):4983-7. doi: 10.4049/jimmunol.1002456. Epub 2010 Sep 27.
Khan SH, Grayson MH. Cross-linking IgE augments human conventional dendritic cell production of CC chemokine ligand 28. J Allergy Clin Immunol. 2010 Jan;125(1):265-7. doi: 10.1016/j.jaci.2009.09.038. Epub 2009 Dec 4. No abstract available.
Subrata LS, Bizzintino J, Mamessier E, Bosco A, McKenna KL, Wikstrom ME, Goldblatt J, Sly PD, Hales BJ, Thomas WR, Laing IA, LeSouef PN, Holt PG. Interactions between innate antiviral and atopic immunoinflammatory pathways precipitate and sustain asthma exacerbations in children. J Immunol. 2009 Aug 15;183(4):2793-800. doi: 10.4049/jimmunol.0900695. Epub 2009 Jul 20.
Cheung DS, Ehlenbach SJ, Kitchens T, Riley DA, Grayson MH. Development of atopy by severe paramyxoviral infection in a mouse model. Ann Allergy Asthma Immunol. 2010 Dec;105(6):437-443.e1. doi: 10.1016/j.anai.2010.09.010.
Grayson MH, Cheung D, Rohlfing MM, Kitchens R, Spiegel DE, Tucker J, Battaile JT, Alevy Y, Yan L, Agapov E, Kim EY, Holtzman MJ. Induction of high-affinity IgE receptor on lung dendritic cells during viral infection leads to mucous cell metaplasia. J Exp Med. 2007 Oct 29;204(11):2759-69. doi: 10.1084/jem.20070360. Epub 2007 Oct 22.
Sigurs N, Bjarnason R, Sigurbergsson F, Kjellman B, Bjorksten B. Asthma and immunoglobulin E antibodies after respiratory syncytial virus bronchiolitis: a prospective cohort study with matched controls. Pediatrics. 1995 Apr;95(4):500-5.
Sammon LM, Hussain SA, Smith M, Rohlfing M, Santoro JL, Grayson MH. Effect of cysteinyl leukotriene receptor 1 blockade on aeroallergen-induced nasal recruitment of CD49d expressing neutrophils. Ann Allergy Asthma Immunol. 2019 Nov;123(5):508-511.e1. doi: 10.1016/j.anai.2019.08.019. Epub 2019 Sep 3. No abstract available.
Other Identifiers
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IRB16-00842
Identifier Type: -
Identifier Source: org_study_id
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