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Xylitol for Otitis Media

Primary Purpose

Otitis Media With Effusion

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

Intranasal xylitol spray

Intranasal saline spray

About this trial

This is an interventional treatment trial for Otitis Media With Effusion

Eligibility Criteria

6 Months - 3 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intranasal xylitol spray

Intranasal saline spray

Arm Description

Two sprays each nostril, twice a day.

Outcomes

Primary Outcome Measures

Time to middle ear effusion resolution

Secondary Outcome Measures

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.

Effect of intranasal xylitol on frequency of episodes of acute otitis media and sinonasal symptoms

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

Tympanostomy tube (TT) placement need

The number of subjects that need TT placement in each arm will be assessed.

Full Information

NCT ID

NCT02950311

First Posted

October 19, 2016

Last Updated

December 20, 2017

Sponsor

Duke University

1. Study Identification

Unique Protocol Identification Number

NCT02950311

Brief Title

Xylitol for Otitis Media

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2017

Overall Recruitment Status

Withdrawn

Why Stopped

On clinical hold with the FDA. Insufficient funds to conduct the study

Study Start Date

November 20, 2017 (Actual)

Primary Completion Date

November 20, 2017 (Actual)

Study Completion Date

November 20, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Duke University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Otitis Media With Effusion

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intranasal xylitol spray

Arm Type

Experimental

Arm Description

Two sprays each nostril, twice a day.

Arm Title

Intranasal saline spray

Arm Type

Placebo Comparator

Arm Description

Two sprays each nostril, twice a day.

Intervention Type

Drug

Intervention Name(s)

Intranasal xylitol spray

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

Intranasal saline spray

Other Intervention Name(s)

Placebo spray

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time to middle ear effusion resolution

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

To evaluate the effect of intranasal xylitol on resolution of the conductive hearing loss associated with middle ear effusion

Description

Results from both audiometry and tympanometry testing are combined to have a comprehensive assessment of conductive hearing loss.

Time Frame

24 weeks

Title

Effect of intranasal xylitol on frequency of episodes of acute otitis media and sinonasal symptoms

Time Frame

24 weeks

Title

Tolerability and side effects of intranasal xylitol administration in children

Description

Will be evaluated descriptively and include all subjects exposed to at least one dose of study drug

Time Frame

24 weeks

Title

Tympanostomy tube (TT) placement need

Description

The number of subjects that need TT placement in each arm will be assessed.

Time Frame

24 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Months

Maximum Age & Unit of Time

3 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marissa Ryan, MD

Organizational Affiliation

Duke University

Official's Role

Principal Investigator

12. IPD Sharing Statement

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Xylitol for Otitis Media

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