Predicting the Response to Montelukast by Genetic Variation in Asthmatics
关键词
抽象
描述
Multiple genetic polymorphisms in the leukotriene pathway have been described but their clinical relevance is unclear. A single nucleotide polymorphism in the LTC4 synthase promoter region has been associated with increased LTC4 synthase mRNA and a trend toward improved bronchodilatory response to leukotriene modifiers in severe asthmatics. This study will examine mild to moderate asthmatics with the variant gene and evaluate the bronchoprotective response of montelukast in a double-blind, placebo-controlled cross-over fashion.
日期
| 最后验证: | 03/31/2007 |
| 首次提交: | 06/27/2005 |
| 提交的预估入学人数: | 06/27/2005 |
| 首次发布: | 06/28/2005 |
| 上次提交的更新: | 04/01/2007 |
| 最近更新发布: | 04/03/2007 |
| 实际学习开始日期: | 03/31/2003 |
| 预计完成日期: | 11/30/2006 |
状况或疾病
干预/治疗
Drug: Montelukast
相
资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Male and female subjects, age 18-55 - Clinical history consistent with asthma - Mild to moderate asthma as determined by pulmonary function tests--60% or higher of predicted FEV1 for age, sex and race. - Response to hypertonic saline, which will be the main outcome variable measured. Exclusion Criteria: - Smokers (total lifetime smoking history>10 pack-years, any in the past year) - Pregnant woman-if of childbearing age, not using an acceptable form of birth control. - Use of a leukotriene modifier within the past month - Use of inhaled or oral steroids within the past month. - Emergency room visit for asthma exacerbation within the past 6 weeks. - Intubation for asthma exacerbation in the past 10 years. - Adverse reaction to inhaled beta-agonists in the past. - No recent (past 48 hours) use of anticholinergics, theophylline, antihistamines, pseudoephedrine. - Patients will also be asked not to use any short acting beta-agonists for 6 hours and long-acting beta-agonists for 48 hours before their initial visit (when pulmonary function evaluation will be performed). - Lung disease other than asthma - Significant medical illness other than asthma |
结果
主要结果指标
1. Change in hypertonic saline PD20 [undefined]
次要成果指标
1. Improved asthma control [undefined]
2. Change in exhaled breath condensate inflammatory markers [undefined]
