Effects of a High or Low Salycilate Diet on Urinary Leucotriene E4 Levels and Clinical Features in Patients With Aspirin Exacerbated Respiratory Disease
试验速览
- 阶段
- 不适用
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change from baseline in Urinary concentration of Leucotriene E4 (LTE4)
研究概览
简要总结
On day one, two groups of nine patients each will respectively recieve the tree daily meals (breakfast, Lunch and dinner) in a controled clinical setting. Group 1 will recieve a low-salycilate diet, and group 2 a high-salycilate diet. Two hours after each meal, urinary Leucotriene E4, FEV1, FVC, FEV1/FVC and total nasal resistance will be measured. On day 7, after clearance time, group 1 will recieve high-salycilate diet and group 2 low salycilate diet and the same measurements will be obtained.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed Aspirin exacerbated respiratory disease.
- •Controled asthma
- •No actual systemic corticosteroid treatment
- •No antileucotriene treatment.
排除标准
- •Patients who do not complete both phases of the study
- •Patients unable to perform adecuate spyrometric testing
- •Patients who present severe asthmatic reactions with high salycilate foods
研究组 & 干预措施
Group 1
Low salycilate diet on day one and High salycilate diet on day 7
干预措施: Low salycilate diet (Other)
Group 2
High salycilate diet on day one and Low salycilate diet on day 7
干预措施: Low salycilate diet (Other)
结局指标
主要结局
Change from baseline in Urinary concentration of Leucotriene E4 (LTE4)
时间窗: Baseline-4-8-12 hours in day one and Baseline-4-8-12 hours in day 7
pg/ml of creatinine
次要结局
- Change from baseline in Vital Capacity (FVC)(Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7)
- Change from baseline in Expiratory Volume in 1 second (FEV-1)(Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7)
- Change from baseline in the Relationship between FEV1/FVC(Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7)
- Change from baseline in the total nasal resistance obtained by rhinometry(Baseline-4-8-12 hours and Baseline-4-8-12 hours in day 7)
研究者
Marcos Alejandro Jimenez Chobillon
Professor
Instituto Nacional de Enfermedades Respiratorias