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临床试验/NCT01778465
NCT01778465已完成不适用

Effect of Low Dietary Salicylate on Biochemical Markers of Aspirin Exacerbated Respiratory Disease

Lawson Health Research Institute2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
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

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.

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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