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

Sponsor

Tel-Aviv Sourasky Medical Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT01967498

Collaborator

(none)

Enrollment

Arms

Duration (Months)

Study Details

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	Phase
Chronic Otitis Media With Effusion Conductive Hearing Loss	Drug: Montelukast	N/A

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.

Study Design

Study Type:

Interventional

Anticipated 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 :

Nov 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2015

Anticipated Study Completion Date :

May 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Experimental: montelukast

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

Drug: Montelukast

Other Names:

Singulair

Placebo Comparator: placebo

Outcome Measures

Primary Outcome Measures

improvement of hearing of 10 db based on pure tone audiometry [3 months]

Secondary Outcome Measures

improvement of tympanometry graph to type A [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

2 Years to 18 Years

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