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

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.

Conditions

• Otitis Media With Effusion

Interventions

DRUG

Lansoprazole

The dosage of Lansoprazole will be administered based on guidelines set out by the prescription drug information outlined in the official Lansoprazole package insert and will remain the same for each patient during the 3 month period and is as follows: a) 1 to 11 years of age, weight less then or equal to 30 kg, 15 mg orally once daily. b) 1 to 11 years of age, weight greater then 30 kg, 30 mg orally once daily. c) 12 years of age and older, 15 mg orally once daily. The doses of Lansoprazole will be prepared in liquid form by the Inpatient Pharmacy at Hamilton Health Sciences.

DRUG

Placebo

Lactose powder in 8.4% Sodium Bicarbonate (Liquid placebo)

Sponsors & Collaborators

• McMaster University

  collaborator OTHER

• Hamilton Health Sciences Corporation

  lead OTHER

Principal Investigators

• Dr. Diane Reid, MD FRCSC · McMaster University

• Dr. Gavin Rukholm, MD · McMaster University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

1 Year

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2010-03-31

Primary Completion

2014-06-30

Completion

2014-06-30

Countries

• Canada

Study Locations