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
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
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
NCT ID
NCT01967498
First Posted
October 17, 2013
Last Updated
October 17, 2013
Sponsor
Tel-Aviv Sourasky Medical Center
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
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