Xylitol for Otitis Media

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Otitis Media With Effusion
• Intervention / Treatment: Drug: Intranasal xylitol spray; Other: Intranasal saline spray

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.

• Study Type: Interventional
• Phase: Phase 2; Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 5 months (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intranasal xylitol spray; Two sprays each nostril, twice a day.	Drug: Intranasal xylitol spray; 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.
Placebo Comparator: Intranasal saline spray; Two sprays each nostril, twice a day.	Other: Intranasal saline spray; 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.; Other Names: Placebo spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to middle ear effusion resolution	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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	Will be evaluated descriptively and include all subjects exposed to at least one dose of study drug	24 weeks
Tympanostomy tube (TT) placement need	The number of subjects that need TT placement in each arm will be assessed.	24 weeks

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Marissa Ryan, MD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2017
• Primary Completion (Actual): November 20, 2017
• Study Completion (Actual): November 20, 2017

Study Registration Dates

• First Submitted: October 19, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): December 22, 2017
• Last Update Submitted That Met QC Criteria: December 20, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Otitis Media with Effusion
• Other Study ID Numbers: Pro00072658

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No