Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study (COME)
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
|Official Title:||Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study|
- improvement of hearing of 10 db based on pure tone audiometry [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- improvement of tympanometry graph to type A [ Time Frame: 3 months ] [ Designated as safety issue: No ]
|Study Start Date:||November 2013|
|Estimated Study Completion Date:||May 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
this arm will receive montelukast as the active intervention of the study
Other Name: Singulair
|Placebo Comparator: placebo|
Chronic otitis media with effusion is a common problem in children that sometimes causes hearing impairment which may affect language development and quality of life of the child. The standard treatment is surgical insertion of ventilation tubes. In the pediatric population this procedure is preformed under general anesthesia and is associated with quite a few possible complications.
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.
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