Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study
NCT ID: NCT01967498
Last Updated: 2013-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
52 participants
INTERVENTIONAL
2013-11-30
2016-05-31
Brief Summary
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Detailed Description
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In this study we will examine the effects of conservative treatment with montelukast on the resolution of the effusion without surgical treatment .
Montelukast is a selective leukotriene receptor antagonist that is widely used for children with asthma1. Allergic rhinitis in children is one of the approved indications for Montelukast.
Montelukast's effect on OME has been studied in several previous studies. In 2004 a study by Combs JT2 showed efficacy of 49% of Montelukast in clearing persistent OME post-AOM. This study was not directed at patients with chronic OME and did not use audiometry as an endpoint. Another study from 2005 by Balatsouras DG studied the effect of montelukast on OME in children suffering from co-existing asthma. The rate of OME resolution after one month of treatment was 60% as opposed to 36% in the control group. The endpoint of this study was OME and not audiometry results. There was no additional followup. In 2010 Schoem SR began a randomized control double blinded study testing the effect of montelukast on children with confirmed OME of 2 months. Montelukast was given for one month. Although the goal was to recruit 120 children, the study was halted after 38 were treated because a statistical trend showed that there was no positive effect compared to the placebo group.
An additional study was published in 2007 performed as a RCT of 77 children did not prove the drug's effectiveness as a treatment for OME . This study was published as an abstract only and no details of the hearing or inclusion criteria were given. Montelukast has been proven effective in resolving experimental OME in a rat model although as opposed to methylpresnisone it did not reduce the submucosal neutrophil infiltrate.
The purpose of our double-blind, placebo controlled study is to test the hypothesis that montelukast therapy might be associated with improved hearing in certain sub populations of children suffering from OME.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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montelukast
this arm will receive montelukast as the active intervention of the study
Montelukast
placebo
No interventions assigned to this group
Interventions
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Montelukast
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients between the ages of 2-10 being evaluated for VT surgery
* Tympanogram type B
* A conductive hearing loss greater than 20 DB
* Otoscopy confirming middle ear effusion
Exclusion Criteria
* history of ear surgery
* cleft palate, Down's syndrome, congenital, malformations of the ear or cholesteatoma
* Sensoneural hearing loss
* Allergy to montelukast
* Moderate or Severe OSA requiring surgery sooner than 3 months
2 Years
18 Years
ALL
Yes
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Other Identifiers
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TASMC-13-MH-0170-13-CTIL
Identifier Type: -
Identifier Source: org_study_id