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

October 17, 2013 updated by: Tel-Aviv Sourasky Medical Center
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 Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

52

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo
Experimental: montelukast
this arm will receive montelukast as the active intervention of the study
Drug: Montelukast
Other Names:
  • Singulair

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
improvement of hearing of 10 db based on pure tone audiometry
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
improvement of tympanometry graph to type A
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tel-Aviv Sourasky Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

December 1, 2015

Study Completion (Anticipated)

May 1, 2016

Study Registration Dates

First Submitted

October 17, 2013

First Submitted That Met QC Criteria

October 17, 2013

First Posted (Estimate)

October 23, 2013

Study Record Updates

Last Update Posted (Estimate)

October 23, 2013

Last Update Submitted That Met QC Criteria

October 17, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TASMC-13-MH-0170-13-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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