Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The accumulation of fluid behind the ear drum without any acute inflammation is known as otitis media with effusion (OME). It is the most common cause of acquired hearing loss during childhood. Long-term complications of OME include linguistic, developmental, and social development delays due to hearing loss.

The cause of OME is not known; however, low grade infection of the middle ear, poor function of the eustachian tube between the ear and the throat, and adenoid hypertrophy have all been suggested as possible etiologies. Recent detection of the stomach enzyme pepsin in middle ear fluid has led some to propose that OME is related to the reflux of stomach contents into the ear, via the eustachian tube.

The purpose of the investigators study is to determine whether anti-reflux medication may have a positive impact by clearing the accumulation of fluid in the middle ear with the aim of preventing or reducing hearing loss in children diagnosed with OME. Empiric anti-reflux therapy with proton pump inhibitor (PPI) medication is safe, proven and cost-effective. It is used widely as a diagnostic and treatment strategy in the presence of the signs and symptoms of gastroesophageal reflux disease (GERD). The signs and symptoms of GERD include heartburn, recurrent vomiting or regurgitation, acid taste in mouth, throat irritation, voice problems, heartburn, difficult or painful swallowing, asthma and recurrent pneumonia.

This pilot study will be a double-blinded, randomized, placebo-controlled trial that will compare resolution rates for OME in children treated with lansoprazole or placebo for three months. At the end of the study, those patients who have persistent middle ear effusions will be brought to the operating room and have the fluid aspirated and sent for analysis for pepsin.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hamilton Health Sciences Corporation
• Collaborator: McMaster University
• Treatments: Dexlansoprazole; Lansoprazole

Criteria

Inclusion Criteria:

• Children between the ages of 1 and 17 years referred to the McMaster Otolaryngology Clinic.

• Presence of bilateral OME for at least 3 months based on:

• Clinical history: patient may present with decrease in hearing, aural fullness and/or ear pressure, balance problems, ear tugging/rubbing, they typically do not have otalgia or fever.

• Pneumatic otoscopy: observations suggestive of OME include presence of a dull tympanic membrane with presence of non purulent effusion (serous or mucoid), presence of a level of effusion, decrease or non motility of the tympanic membrane, retraction of the tympanic membrane.

• Tympanometry: type B or type C tympanogram with normal air volume of the external auditory canal.

• Pure tone audiometry: conductive hearing loss that typically varies from slight to moderate.

Exclusion Criteria:

• Presence of acute otitis media as determined by history and physical examination:

• History of rapid acute onset of significant otalgia, decrease in hearing, fever, irritability.

• Pneumatic otoscopy revealing purulent effusion, yellowness and/or redness with hypervascularity of the tympanic membrane, bulging of tympanic membrane with decrease of normal landmarks.

• Presence of craniofacial abnormalities

• Previous middle ear surgery (excluding myringotomy and tube)

• Allergic reactions to lansoprazole, and any other adverse drug interactions to lansoprazole.