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Withdrawn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
About this trial
This is an interventional treatment trial for Otitis Media With Effusion
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.
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
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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