search
Back to results

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

Primary Purpose

Chronic Otitis Media With Effusion, Conductive Hearing Loss

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Montelukast
Sponsored by
Tel-Aviv Sourasky Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Otitis Media With Effusion focused on measuring chronic otitis media with effusion, conductive hearing loss

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Placebo Comparator

    Arm Label

    montelukast

    placebo

    Arm Description

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

    Outcomes

    Primary Outcome Measures

    improvement of hearing of 10 db based on pure tone audiometry

    Secondary Outcome Measures

    improvement of tympanometry graph to type A

    Full Information

    First Posted
    October 17, 2013
    Last Updated
    October 17, 2013
    Sponsor
    Tel-Aviv Sourasky Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01967498
    Brief Title
    Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study
    Acronym
    COME
    Official Title
    Montelukast for Children With Chronic Otitis Media With Effusion (COME): A Double-blind, Placebo-controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2013
    Overall Recruitment Status
    Unknown status
    Study Start Date
    November 2013 (undefined)
    Primary Completion Date
    December 2015 (Anticipated)
    Study Completion Date
    May 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Tel-Aviv Sourasky Medical Center

    4. Oversight

    5. 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.
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Chronic Otitis Media With Effusion, Conductive Hearing Loss
    Keywords
    chronic otitis media with effusion, conductive hearing loss

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    52 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    montelukast
    Arm Type
    Experimental
    Arm Description
    this arm will receive montelukast as the active intervention of the study
    Arm Title
    placebo
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Montelukast
    Other Intervention Name(s)
    Singulair
    Primary Outcome Measure Information:
    Title
    improvement of hearing of 10 db based on pure tone audiometry
    Time Frame
    3 months
    Secondary Outcome Measure Information:
    Title
    improvement of tympanometry graph to type A
    Time Frame
    3 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    2 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    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

    12. IPD Sharing Statement

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs