Anti-Inflammatory Effect of Polyunsaturated Fatty Acids in Allergic Asthma After Allergen Challenge
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 主要终点
- lung function, symptom score,exhalative nitric oxide, metacholine testing
研究概览
简要总结
Native populations consuming high amounts of fish suffer less from allergic diseases. The purpose of this study is to determine whether polyunsaturated fatty acids (fish oil) might have a disease modifying influence on asthmatics sensitized to house dust mite.
详细描述
Most asthmatics suffer from mild disease and non pharmacologic intervention would be beneficial for the majority of these subjects. We investigated the anti-inflammatory potential of polyunsaturated fatty acids (PUFA) in allergic asthma.
In our parallel, double-blinded study, 23 patients allergic to house dust mite were randomly assigned to dietary supplementation with a PUFA enriched fat blend or placebo for five weeks. The verum contained eicosapentaenoic acid (EPA) 450 mg/day, docosahexaenoic acid 180 mg/day, stearidonic acid 60mg/day, and gamma-linolenic acid 60 mg/day; the placebo consisted of mainly unsaturated and monosaturated fatty acids. After three weeks, the patients were challenged with low doses of inhalative house dust mite allergen for two weeks.
Following parameters were determined during low-dose allergen exposure in both groups: exhaled NO (eNO) as a marker of bronchial inflammation, clinical symptoms, FEV1, beta-agonist usage, and bronchial hyperreactivity, sputum eosinophils and sulfoleucotrienes. Compliance with the study protocol was controlled by the determination of PUFAs in plasma and erythrocytes.
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
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •allergic sensitization to house dust mite as proven by skin test and specific IgE
- •normal lung function, episodic asthma
排除标准
- •history of hypersensitization towards fish oil, chronic illness, pregnancy
结局指标
主要结局
lung function, symptom score,exhalative nitric oxide, metacholine testing
次要结局
- sulfoleucotriens, eosinophilic cationic protein, sputum eosinophils, safety lab parameters (clinical chemistry, hematology, hemostasis)