Comparative Effects of Fish Oil Supplementation and a Leukotriene Receptor Antagonist on EIB and Airway Inflammation in Asthma
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Pulmonary function
研究概览
简要总结
Combining fish oil supplementation and Montelukast [a commonly used cyst LT1 receptor antagonist to treat exercise-induced bronchoconstriction (EIB)] will provide a greater antiinflammatory effect against developing EIB that either agent alone
详细描述
The aim of this study is to extend previous published findings that fish oil supplementation represents a beneficial treatment on exercise-induced bronchoconstriction (EIB). An important question is how dietary fish oil supplementation fits in with the available armamentarium [e.g., leukotriene (LT) modifiers] to decrease the expression of LTs, and whether fish oil supplementation may be additive, or used in its own right to block the EIB response. For example, it is possible that a combination of fish oil supplementation and a cyst LT1 receptor antagonist (LTRA) may provide a greater antiinflammatory effect against developing EIB that either agent alone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Demonstrate a fall in post-exercise FEV1 of > 10% after dry air exercise challenge for the diagnosis of EIB and
- •> 12% increase in FEV1 from the baseline value after the administration of a β2-agonist. However, if the bronchodilator response is < 12% increase in FEV1 from the baseline value then asthmatic subjects with EIB must further demonstrate
- •A < 16.0 mg.ml-1 concentration of methacholine causing a 20% decrease in FEV1 (PC20)
排除标准
- •Subjects will be excluded if they are pregnant
- •Have a history of hyperlipidemia, hypertension, diabetes, bleeding disorders, delayed clotting time
- •Taking aspirin medication and have a resting FEV1 less than 65% predicted.
- •A complete blood count and urinary pregnancy tests will be conducted at the beginning of the study and subjects with a hematocrit < 35 will be excluded from participation in the study.
- •In addition, subjects will also be excluded if they have a history of taking n-3 PUFA supplements or supplements with antioxidants above the levels recommended for Adequate Intake, or regularly consume more than one fish meal per week.
结局指标
主要结局
Pulmonary function
时间窗: 6 weeks
次要结局
- Exhaled breathe condensate markers to measure airway inflammation(6 weeks)