Treatment of Post-Operative Sinonasal Polyposis With Topical Furosemide
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Polyp Recurrence
研究概览
简要总结
Prior studies have suggested that topical furosemide may reduce the recurrence of sinonasal polyposis following sinus surgery. This project aims to further investigate that claim through a blinded randomized controlled clinical trial following patients who undergo functional sinus surgery for chronic rhinosinusitis with sinonasal polyposis by randomly assigning participants to receive topical furosemide versus placebo nasal spray for 2 months post operatively. Outcomes would be compared at 6 months through endoscopic grading scores using Lund Kennedy and Meltzer scores as well as Sino-Nasal Outcome Test (SNOT-22) scores to measure the rate and degree of recurrence and impact on symptoms in the treatment group versus placebo.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with chronic rhinosinusitis and sinonasal polyposis who are candidates for functional endoscopic sinus surgery
排除标准
- •Hypersensitivity to furosemide or sulfonamides
- •pregnancy
- •history of tinnitus
- •history of sensorineural hearing loss
- •poorly controlled diabetes
- •current diuretic therapy
- •known electrolyte disorder
- •currently taking aminoglycosides
- •BUN and creatinine levels out of the normal range
- •history of renal disease
- •allergy to sulfonamides
研究组 & 干预措施
Furosemide
干预措施: Furosemide (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Polyp Recurrence
时间窗: 6 months
Nasal and paranasal polyposis based Sino-Nasal Outcome Test (SNOT-22) scores to measure impact on symptoms.
次要结局
未报告次要终点