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

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ClinicalTrials.gov Identifier: NCT01967498
Recruitment Status : Unknown
Verified October 2013 by Tel-Aviv Sourasky Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : October 23, 2013
Last Update Posted : October 23, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Chronic Otitis Media With Effusion Conductive Hearing Loss Drug: Montelukast

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 Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 52 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (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
Study Start Date : November 2013
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
Drug Information available for: Montelukast
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: montelukast
this arm will receive montelukast as the active intervention of the study
Drug: Montelukast
Other Name: Singulair
Placebo Comparator: placebo


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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

Responsible Party: Tel-Aviv Sourasky Medical Center
ClinicalTrials.gov Identifier: NCT01967498     History of Changes
Other Study ID Numbers: TASMC-13-MH-0170-13-CTIL
First Posted: October 23, 2013    Key Record Dates
Last Update Posted: October 23, 2013
Last Verified: October 2013

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

Additional relevant MeSH terms:
Hearing Loss
Deafness
Otitis
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
Montelukast
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