Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Urinary Levels of Cys-Leukotrienes
研究概览
简要总结
Aspirin-Exacerbated Respiratory Disease, or AERD, consists of aspirin sensitivity, asthma and nasal polyps. It is currently managed by chronic steroid use, multiple endoscopic sinus surgeries and/or aspirin desensitization. However, these treatments have potential adverse effects.
A theory has been postulated that decreasing the level of dietary salicylates may help in long-term control of disease. A current trial is in the works to evaluate the clinical outcomes of decreased salicylate, but measurements of biochemical markers of disease has not yet been done. The hypothesis is that decreased dietary salicylates will result in a decrease in urinary salicylates and inflammatory markers of disease, cys-leukotrienes, which are typically elevated in this disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients
- •Aspirin-exacerbated respiratory disease
排除标准
- •recent use of Prednisone or other systemic steroids (greater than 3 doses in past 3 months)
- •Endoscopic sinus surgery or polypectomy within the past 6 months
- •Other significant systemic disease, including renal failure, or immunocompromised state.
研究组 & 干预措施
Low salicylate diet, then Normal Diet
Patients followed a low salicylate diet for one week, then they followed a Normal diet for another week.
干预措施: Low salicylate diet (Behavioral)
Normal diet, then Low Salicylate diet
Patients followed a Normal diet for one week, then they followed a Low Salicylate diet for another week.
干预措施: Normal Diet (Behavioral)
结局指标
主要结局
Urinary Levels of Cys-Leukotrienes
时间窗: 14 days after commencement
Urinary Salicyluric Acid Levels
时间窗: 14 days after commencement
Urinary Salicylic Acid Levels
时间窗: 14 days after enrollment
Urinary Creatinine Levels
时间窗: 14 days after commencement
次要结局
- Sino-Nasal Outcome Test (SNOT-22)(14 days after commencement)