A Prospective, Randomized, Double-blinded, Placebo-controlled Pilot Study for Evaluating the Effectiveness of Intranasal Xylitol in Treating Otitis Media With Effusion (OME) in Children
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 主要终点
- Time to middle ear effusion resolution
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled study of children, age 6 months to 3 years, with a diagnosis of Otis media with effusion (OME) based on examination by a provider at a Duke- affiliated otolaryngology clinic.
详细描述
The primary purpose of this study is to evaluate the efficacy of intranasal xylitol in young children with otitis media with effusion as measured by the resolution of middle ear effusion based on physical examination and tympanometry at 6-, 12-, and 18 and 24-weeks post-treatment. Eligible subjects will be randomly assigned to receive either intranasal xylitol spray or a nasal saline spray placebo and will be observed for 24-weeks following initiation of daily xylitol spray or placebo. The primary efficacy endpoint, the time to middle ear effusion resolution with and without the xylitol nasal spray, will be analyzed using either a two-sample t-test or non-parametric Wilcoxon test, depending on whether the time is normal or non-normal. Risks include epistaxis, diarrhea, and allergic reaction. Serious adverse events are not anticipated.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 6 Months 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 6 months and 3 years of age.
- •Clinical diagnosis of OME. Treated at Duke for the above condition.
- •Ability of parent/guardian to be compliant with at-home nasal spray administration.
排除标准
- •History of immunodeficiency or an immunologic disorder that predisposes to frequent infections.
- •History of prior pressure-equalization (PE) tube placement and the tubes are still in place.
- •Active or recent (<1 month prior to screening) middle ear disease, including but not limited to: cholesteatoma, tympanic membrane perforation, congenital external or middle ear abnormalities or malformations.
- •History of previous otologic surgery including tympanoplasty, and/or mastoidectomy.
- •Previous use of intranasal sprays other than normal saline, including intranasal steroids, and/or xylitol within 1 month prior to screening.
- •Any other clinically significant illness or medical condition, per PI discretion, that would prohibit the subject from participating in the study.
- •Subject has previously been randomized to a trial of Xylitol.
- •Parent/guardian is unable to administer the study nasal spray.
- •Parent/guardian is unable to read, write, and understand English.
- •Parent/guardian is unable to provide legally effective consent.
研究组 & 干预措施
Intranasal xylitol spray
Two sprays each nostril, twice a day.
干预措施: Intranasal xylitol spray (Drug)
Intranasal saline spray
Two sprays each nostril, twice a day.
干预措施: Intranasal saline spray (Other)
结局指标
主要结局
Time to middle ear effusion resolution
时间窗: 24 weeks
次要结局
- To evaluate the effect of intranasal xylitol on resolution of the conductive hearing loss associated with middle ear effusion(24 weeks)
- Effect of intranasal xylitol on frequency of episodes of acute otitis media and sinonasal symptoms(24 weeks)
- Tolerability and side effects of intranasal xylitol administration in children(24 weeks)
- Tympanostomy tube (TT) placement need(24 weeks)