Xylitol for Otitis Media

NCT02950311 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: Pro00072658
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Otitis Media With Effusion

Outcome Measures

Primary Outcomes (1)

• Time to middle ear effusion resolution

  24 weeks

Secondary Outcomes (4)

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

  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

  24 weeks

• Tympanostomy tube (TT) placement need

  24 weeks

Study Arms (2)

Intranasal xylitol spray

EXPERIMENTAL

Two sprays each nostril, twice a day.

Drug: Intranasal xylitol spray

Intranasal saline spray

PLACEBO COMPARATOR

Two sprays each nostril, twice a day.

Other: Intranasal saline spray

Interventions

Intranasal xylitol spray DRUG

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.

Intranasal xylitol spray

Intranasal saline spray OTHER

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.

Also known as: Placebo spray

Intranasal saline spray

Eligibility Criteria

• Age: 6 Months - 3 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

MeSH Terms

Conditions

Otitis Media with Effusion

Condition Hierarchy (Ancestors)

Otitis Media; Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Study Officials

• Marissa Ryan, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 19, 2016
• First Posted: November 1, 2016
• Study Start: November 20, 2017
• Primary Completion: November 20, 2017
• Study Completion: November 20, 2017
• Last Updated: December 22, 2017

Record last verified: 2017-12