Otitis Media With Effusion Clinical Trial
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
Verified date | December 2017 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 20, 2017 |
Est. primary completion date | November 20, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 6 Months to 3 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Duke University |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time to middle ear effusion resolution | 24 weeks | ||
Secondary | 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 | |
Secondary | Effect of intranasal xylitol on frequency of episodes of acute otitis media and sinonasal symptoms | 24 weeks | ||
Secondary | 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 | |
Secondary | Tympanostomy tube (TT) placement need | The number of subjects that need TT placement in each arm will be assessed. | 24 weeks |
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