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临床试验/ACTRN12616000329460
ACTRN12616000329460已完成1 期

The effect of chitosan-dextran (Chitodex) gel with budesonide and mupirocin on recalcitrant rhinosinusitis

The Queen Elizabeth Hospital0 个研究点目标入组 38 人开始时间: 2016年3月14日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
38

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Open (masking not used)

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • Selection/inclusion criteria:
  • Patients who meet ALL of the following criteria will be offered inclusion in the study:
  • (1)Those who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND
  • (2)have had at least one operation for their chronic rhinosinusitis > 12 weeks prior to enrolment AND
  • (3)continue to have ongoing symptoms despite surgical management AND
  • (4)have not responded to at least one course of oral antibiotics
  • (5)have a positive sinonasal swab that indicates infection of the sinuses AND
  • (6)are over 18 years of age AND
  • (7)are able to give written informed consent AND
  • (8)are local patients who will be returning to this centre for postoperative follow-up care

排除标准

  • (1)allergy to shellfish, steroids or mupirocin
  • (2)pregnant or breastfeeding
  • (3)immunodeficient patients (patients on any immunosuppressive or immunomodulatory agent)
  • (4)on other CYP450 inhibiting drugs (e.g. ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin)
  • (5)liver disease

研究者

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