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

Conductive Hearing Loss Clinical Trial

— COME  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01967498
• Other study ID #: TASMC-13-MH-0170-13-CTIL
• Status: Not yet recruiting
• Phase: N/A
• First received: October 17, 2013
• Last updated: October 17, 2013
• Start date: November 2013
• Est. completion date: May 2016

Study information

• Verified date: October 2013
• Source: Tel-Aviv Sourasky Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 52
• Est. completion date: May 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Otitis Media With Effusion
• Conductive Hearing Loss
• Deafness
• Hearing Loss
• Hearing Loss, Conductive
• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Drug:
• Montelukast

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Tel-Aviv Sourasky Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	improvement of hearing of 10 db based on pure tone audiometry		3 months	No
Secondary	improvement of tympanometry graph to type A		3 months	No