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临床试验/NCT00318006
NCT00318006已完成4 期

A Randomized Study of Nasal Irrigation Versus Nasal Spray for Chronic Nasal and Sinus Symptoms

University of Michigan2 个研究点 分布在 1 个国家目标入组 127 人开始时间: 2005年12月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
127
试验地点
2
主要终点
Change in the mean score of the sinonasal outcome test-20

研究概览

简要总结

This study will compare nasal saline irrigation with nasal saline spray for the treatment of chronic nasal and sinus symptoms. Participants will complete a questionnaire regarding their nasal and sinus symptoms and will be randomly assigned to one of the treatment groups. Each participant will be instructed on how to perform daily nasal treatment.The subjects will complete follow-up surveys at regular intervals to assess any change in their nasal symptoms after starting nasal saline treatment. Participants may take their usual medications for sinus symptoms during their participation in the study.

详细描述

See publication: Arch OtolaryngolHeadNeckSurg. 2007;133(11):1115-1120

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

  • Age > 18 years
  • Presence of any one of the following symptoms for > 4 days/week and > 15 days in the past 1 month:
  • Nasal stuffiness
  • Nasal congestion
  • Nasal dryness or crusting
  • Abnormal nasal discharge
  • Thick nasal discharge

排除标准

  • Functional endoscopic sinus surgery (FESS) in the last 3 months
  • Epistaxis in the last 3 months that required treatment
  • Acute illness like otitis media, laryngitis, pharyngitis, or rhinitis in the last 2 weeks
  • Acute attack of asthma or bronchitis in the last 2 weeks
  • Inability to speak or read English
  • Current use of any of the study medications regularly for more than a week in the last 1 month
  • Any history of intolerance to saline treatment (if used)

结局指标

主要结局

Change in the mean score of the sinonasal outcome test-20

Change in medication usage for nasal and sinus symptoms

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Melissa Pynnonen

Associate Professor of Otolaryngology

University of Michigan

研究点 (2)

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