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临床试验/NCT02194062
NCT02194062已完成不适用

A Comparison of Budesonide Nasal Irrigation in Different Head Positions and Fluticasone Nasal Spray in Post-operative Functional Endoscopic Sinus Surgery Patients With Chronic Rhinosinusitis With Nasal Polyposis

Yale University2 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2015年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
32
试验地点
2
主要终点
SNOT-22 Scores

研究概览

简要总结

The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal saline rinses in both the upright and head forward positions in patients who have had functional endoscopic sinus surgery (FESS) for chronic rhinosinusitis with nasal polyposis (CRSwNP) and measure differences in Sinonasal Outcome Test-22 (SNOT-22) scores and Lund- Kennedy scores on rigid nasal endoscopy at time points 1 week, 3 weeks, 6 weeks, 2 months, 4 months, and 6 months post-op.

详细描述

Chronic rhinosinusitis (CRS) is an inflammatory condition of the lining of the nose and sinuses that lasts 12 weeks or longer with objective evidence of mucosal inflammation (1). CRSwNP is characterized by the presence of bilateral nasal polyps in the middle meatus. Patients with CRSwNP for whom medical therapy has failed, often have functional endoscopic sinus surgery.

Nasal steroids are important post-operatively to prevent polyps from recurring. Many studies have shown that nasal steroids are superior to placebo in maintaining improvement in symptom scores, such as SNOT-22, post-operatively by preventing polyps from returning (2). Nasal steroids can reduce inflammation locally and can prevent disease relapse without the systemic effects of oral steroids. However, there is no consensus as to which nasal steroid and which delivery method is most effective in treating these patients. Traditional nasal sprays, such as fluticasone spray, may not deliver the medication widely in the nasal cavity. Budesonide is available in a respule form that can be used to instill the medication in the nose. In an attempt to more effectively deliver the medication, changes in patient's head position has been prescribed to achieve better delivery (3). The safety of intranasal budesonide, a more potent steroid than fluticasone, has been established (4, 5). However, any improved efficacy over fluticasone nasal spray remains anecdotal as head to head comparisons have not previously been performed.

Practice patterns among rhinologists in the post-operative prescription of nasal steroids vary widely. Determining which medication/delivery method is more effective will help rhinologists better treat their patients and prevent symptoms, for which the surgery was performed, from returning.

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
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

入选标准

  • Adult patients who have had FESS for CRSwNP within the study period

排除标准

  • Patients who are under the age of 18
  • Concurrent oral corticosteroid use of the equivalent of greater than 10 mg of prednisone use per day
  • The use of medications that accelerate the clearance of systemic cortisol (Dilantin, rifampin, amphetamines, and lithium)
  • The use of medications that inhibit the clearance of systemic cortisol (ketoconazole, amphotericin B, bupropion, fluoroquinolones)
  • Known hypersensitivity to corticosteroids
  • A personal history of Wegener's Granulomatosis or other autoimmune disease with nasal manifestations

研究组 & 干预措施

fluticasone nasal spray

Active Comparator

Group one will be prescribed fluticasone nasal spray ( to use 2-50 mcg sprays to each nostril two times per day)

干预措施: fluticasone nasal spray (Drug)

budesonide respule in head upright

Active Comparator

Group two will be prescribed budesonide respules (0.5 mg/2mL) to instill into each nostril in the upright position two times per day

干预措施: Budesonide head upright (Drug)

budesonide head forward

Active Comparator

Group three will be prescribed budesonide respules (0.5 mg/2mL) to use instill into each nostril in the head forward position two times per day with their head angled downwards by having their head lean forward off the side of a bed.

干预措施: Budesonide head forward (Drug)

结局指标

主要结局

SNOT-22 Scores

时间窗: 6 months post-op.

SNOT22 is a validated scale which measures sinonasal symptoms for sinusitis patients. The 22 questions are rated on a scale of 0-5 for a maximum total score of 110. Higher scores represent more symptomatic patients.

次要结局

  • Lund-Kennedy Scoring for Nasal Endoscopy(6 months post-op)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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