Double Blind Study of Leukotriene Antagonism in the Nasal Recruitment of CD49d Expressing Neutrophils in Atopic Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Change in frequency in CD49d+ neutrophils in the nasal lavage post-allergen challenge on placebo versus Montelukast.
研究概览
简要总结
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).
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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
干预措施: Nasal lavage (Procedure)
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
干预措施: Nasal allergen challenge (Procedure)
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
干预措施: Epicutaneous skin testing (Procedure)
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
干预措施: Peripheral blood (Procedure)
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
干预措施: Montelukast 10Mg Tablet (Drug)
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.
干预措施: Nasal lavage (Procedure)
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.
干预措施: Nasal allergen challenge (Procedure)
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.
干预措施: Peripheral blood (Procedure)
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.
干预措施: Placebo Oral Tablet (Drug)
结局指标
主要结局
Change in frequency in CD49d+ neutrophils in the nasal lavage post-allergen challenge on placebo versus Montelukast.
时间窗: 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.
次要结局
- Change in clinical response following nasal allergen challenge after one week of treatment with Montelukast.(1 month)
研究者
Mitchell Grayson
Principal Investigator
Nationwide Children's Hospital