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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Tel-Aviv Sourasky Medical Center Identifier:
First received: October 17, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
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.

Condition Intervention
Chronic Otitis Media With Effusion
Conductive Hearing Loss
Drug: Montelukast

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study

Resource links provided by NLM:

Further study details as provided by Tel-Aviv Sourasky Medical Center:

Primary Outcome Measures:
  • improvement of hearing of 10 db based on pure tone audiometry [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • improvement of tympanometry graph to type A [ Time Frame: 3 months ]

Estimated Enrollment: 52
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)
Arms Assigned Interventions
Experimental: montelukast
this arm will receive montelukast as the active intervention of the study
Drug: Montelukast
Other Name: Singulair
Placebo Comparator: placebo

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.


Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

Responsible Party: Tel-Aviv Sourasky Medical Center Identifier: NCT01967498     History of Changes
Other Study ID Numbers: TASMC-13-MH-0170-13-CTIL
Study First Received: October 17, 2013
Last Updated: October 17, 2013

Keywords provided by Tel-Aviv Sourasky Medical Center:
chronic otitis media with effusion
conductive hearing loss

Additional relevant MeSH terms:
Hearing Loss
Otitis Media
Otitis Media with Effusion
Hearing Loss, Conductive
Hearing Disorders
Ear Diseases
Otorhinolaryngologic Diseases
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Anti-Asthmatic Agents
Respiratory System Agents
Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017