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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Withdrawn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
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

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.

    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

    First Posted
    October 19, 2016
    Last Updated
    December 20, 2017
    Sponsor
    Duke University
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    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
    No
    Product Manufactured in and Exported from the U.S.
    No
    Data Monitoring Committee
    No

    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
    No
    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

    Learn more about this trial

    Xylitol for Otitis Media

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