Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study

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Brief Title

Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study

Official Title

Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study

Brief Summary

      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.
    

Detailed Description

      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.
    


Study Type

Interventional


Primary Outcome

improvement of hearing of 10 db based on pure tone audiometry

Secondary Outcome

 improvement of tympanometry graph to type A

Condition

Chronic Otitis Media With Effusion

Intervention

Montelukast

Study Arms / Comparison Groups

 montelukast
Description:  this arm will receive montelukast as the active intervention of the study

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

52

Start Date

November 2013

Completion Date

May 2016

Primary Completion Date

December 2015

Eligibility Criteria

        Inclusion Criteria:

          -  Documented persistent OME of at least 3 months (otoscopy or audiometry or
             tympanometry)

          -  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:

          -  previous adenoidectomy or tonsillectomy

          -  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
      

Gender

All

Ages

2 Years - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

, , 



Administrative Informations


NCT ID

NCT01967498

Organization ID

TASMC-13-MH-0170-13-CTIL


Responsible Party

Sponsor

Study Sponsor

Tel-Aviv Sourasky Medical Center


Study Sponsor

, , 


Verification Date

October 2013