Otitis Media With EffusionPhase 2/3NCT02950311
Xylitol for Otitis Media
A Phase 2/3 study testing Intranasal xylitol spray and Intranasal saline spray in people with Otitis Media With Effusion, run by Duke University.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 months to 3 years
- Conditions the study is for
- Otitis Media With Effusion
- What is being tested?
- Intranasal xylitol spray and Intranasal saline spray
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2017to 20 Nov 2017
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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.
Read the 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.
- Conditions
- Otitis Media With Effusion
- Being tested
- Intranasal xylitol spray, Intranasal saline spray
- Medical subject headings
- Otitis Media with Effusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intranasal xylitol sprayDrug
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 saline sprayOther
Also called Placebo spray
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.
| Study group | Role | What they receive |
|---|---|---|
| Intranasal xylitol spray | Experimental | Two sprays each nostril, twice a day. Receives: Drug: Intranasal xylitol spray |
| Intranasal saline spray | Placebo comparator | Two sprays each nostril, twice a day. Receives: Other: Intranasal saline spray |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to middle ear effusion resolution
Measured: 24 weeks
Secondary outcomes (4)
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.
Measured: 24 weeks
Effect of intranasal xylitol on frequency of episodes of acute otitis media and sinonasal symptoms
Measured: 24 weeks
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
Measured: 24 weeks
Tympanostomy tube (TT) placement need
The number of subjects that need TT placement in each arm will be assessed.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study start20 Nov 2017
- Primary completion20 Nov 2017
- Study completion20 Nov 2017
Why it stopped: On clinical hold with the FDA. Insufficient funds to conduct the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Otitis Media With EffusionStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marissa Ryan, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950311
- Sponsor's protocol ID
- Pro00072658
- Status last verified
- Dec 2017
- First submitted
- 19 Oct 2016
- Last updated
- 22 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02950311
- Acronym / sponsor ID
- Pro00072658
- Conditions
- Otitis Media With Effusion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: On clinical hold with the FDA. Insufficient funds to conduct the study
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 20 Nov 2017 (actual)
- Primary completion
- 20 Nov 2017 (actual)
- Study completion
- 20 Nov 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal xylitol spray | Experimental | Drug: Intranasal xylitol sprayTwo sprays each nostril, twice a day. |
| Intranasal saline spray | Placebo comparator | Other: Intranasal saline sprayTwo sprays each nostril, twice a day. |
Who may qualify
- Ages
- 6 months to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intranasal xylitol sprayTwo sprays into each nostril of intranasal xylitol spray will be administered to pediatric patients by parent(s)/caregiver(s) twice daily for 24 weeks. | Drug | Intranasal xylitol spray |
| Intranasal saline sprayAlso: Placebo sprayTwo sprays into each nostril of intranasal xylitol spray will be administered to pediatric patients by parent(s)/caregiver(s) twice daily for 24 weeks. | Other | Intranasal saline spray |
Primary outcome
Time to middle ear effusion resolution
Time frame: 24 weeks
4 secondary outcomes
To evaluate the effect of intranasal xylitol on resolution of the conductive hearing loss associated with middle ear effusion
Time frame: 24 weeks
Effect of intranasal xylitol on frequency of episodes of acute otitis media and sinonasal symptoms
Time frame: 24 weeks
Tolerability and side effects of intranasal xylitol administration in children
Time frame: 24 weeks
Tympanostomy tube (TT) placement need
Time frame: 24 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marissa Ryan, MD principal investigator
Duke University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intranasal xylitol spray and Intranasal saline spray in people with Otitis Media With Effusion, run by Duke University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 22 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to middle ear effusion resolution (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2017.