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
Overview
- Phase
- Phase 2
- Intervention
- Intranasal xylitol spray
- Conditions
- Otitis Media With Effusion
- Sponsor
- Duke University
- Primary Endpoint
- Time to middle ear effusion resolution
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
Intranasal xylitol spray
Two sprays each nostril, twice a day.
Intervention: Intranasal xylitol spray
Intranasal saline spray
Two sprays each nostril, twice a day.
Intervention: Intranasal saline spray
Outcomes
Primary Outcomes
Time to middle ear effusion resolution
Time Frame: 24 weeks
Secondary Outcomes
- 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)