The Effect of Montelukast on Inflammatory Responses of Nasal Epithelial Cells Cultured From Patients With Asthma, With and Without Concomitant Allergic Rhinitis
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Effect of montelukast on nasal epithelial cell secretion in vitro.
研究概览
简要总结
The airways of the lung are lined by specialised cells called airway epithelial cells. As well as being at the interface between the lungs and the air we breathe; airway epithelial cell (AEC) function is altered in people with respiratory diseases such as asthma. AEC secrete many mediators that contribute to asthma symptoms and these also contribute to asthmatic inflammation in the lungs. The study of such cells is difficult because of their location deep in the lungs. Nasal airway epithelial cells provide a useful and easily accessible model of model of lower airway cells. This study will examine whether the asthma medication Singulair (montelukast) can inhibit the inflammatory secretions of nasal AEC of asthmatic patents who also have allergic rhinitis compared with patients who have asthma alone. We will also examine if montelukast has differential modulating effects in these two patient groups.
详细描述
Hypothesis
The inflammatory secretory profile of nasal airway epithelial cells (NEC) cultured from asthmatics with concomitant allergic rhinitis (AR) will differ from that of NEC from patients with asthma alone. Treatment (in vitro and in vivo) with montelukast may have differential modulating effects in these two patient groups.
For the primary objective of this proposal we will use nasal AEC from asthmatics with or without concomitant AR as to ascertain differences in pro-inflammatory cytokine and chemokine production between these two groups and determine whether in vitro treatment with montelukast has a differential modulating effect on NEC secretion. In the secondary pilot study any modulating effects by montelukast on AEC secretion in vitro will be correlated with any in vivo response to montelukast withdrawal. This sub study will provide pilot data indicating whether in vivo response to montelukast can be predicted from in vitro effects on NEC.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 10 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable physician confirmed mild/moderate asthma (Steps 1-4 of BTS/SIGN guidelines <10 pack-year smoking histories Currently taking montelukast with a documented clinical history of benefit
排除标准
- •Nasal corticosteroid therapy
结局指标
主要结局
Effect of montelukast on nasal epithelial cell secretion in vitro.
时间窗: 12 months
* Nasal AEC will be cultured from 20 patients with asthma and 20 patients with asthma and concomitant allergic rhinitis. * Unstimulated, TNFα (a surrogate for viral infection, a well known trigger of exacerbations) or allergen stimulated secretion of IL-6, IL-10, INFgamma TGFbeta, GM-CSF, eotaxin 1 \& 2, RANTES and IL-8 by NEC will be measured. The in vitro inhibitory effects of a concentration range (10-6M to 10-10M) of montelukast will be assessed.
次要结局
- Effect of 1-week montelukast withdrawal on clinical scores and pro-inflammatory cytokine output by nasal epithelial cells(12 months)