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

• Status: Unknown status
• Trial end date: 2016-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Treatments: Montelukast

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