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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Two sprays into each nostril of intranasal xylitol spray will be administered to pediatric patients by parent(s)/caregiver(s) twice daily for 24 weeks.
Two sprays into each nostril of intranasal xylitol spray will be administered to pediatric patients by parent(s)/caregiver(s) twice daily for 24 weeks.
Time to middle ear effusion resolution
Time frame: 24 weeks
To evaluate the effect of intranasal xylitol on resolution of the conductive hearing loss associated with middle ear effusion
Results from both audiometry and tympanometry testing are combined to have a comprehensive assessment of conductive hearing loss.
Time frame: 24 weeks
Effect of intranasal xylitol on frequency of episodes of acute otitis media and sinonasal symptoms
Time frame: 24 weeks
Tolerability and side effects of intranasal xylitol administration in children
Will be evaluated descriptively and include all subjects exposed to at least one dose of study drug
Time frame: 24 weeks
Tympanostomy tube (TT) placement need
The number of subjects that need TT placement in each arm will be assessed.
Time frame: 24 weeks
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