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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01082029
Recruitment Status : Completed
First Posted : March 5, 2010
Last Update Posted : April 14, 2015
McMaster University
Information provided by (Responsible Party):
Gavin Rukholm, McMaster University

Tracking Information
First Submitted Date  ICMJE March 4, 2010
First Posted Date  ICMJE March 5, 2010
Last Update Posted Date April 14, 2015
Study Start Date  ICMJE March 2010
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 4, 2010)
Collect the required data for sample size calculation [ Time Frame: Following the recruitment of 100 patients (~1 year) ]
The purpose of this pilot study is to collect required data for a sample size calculation for a larger clinical trial and to determine recruitment rates.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01082029 on Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 4, 2010)
Resolution of Otitis Media with Effusion [ Time Frame: At presentation and at 1 month, 2months and 3 months post initiation of treatment ]
The secondary objectives are to compare the duration of OME between the placebo and treatment groups, and to compare the duration and degree of hearing loss at initial presentation and at three months. Other outcomes include degree of hearing improvement, complications of OME (i.e. recurrent OME, acute otitis media, surgery), frequency and severity of GERD symptoms, side effects of Lansoprazole use, and presence of pepsin in middle ear effusions collected from patients who received surgical treatment.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE Study of Anti-reflux Medication as a Potential Treatment for Glue Ear in Children
Official Title  ICMJE Role of Empiric Anti-reflux Therapy in Pediatric Otitis Media With Effusion - a Pilot Study
Brief 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.

Detailed Description

Otitis media with effusion (OME) is a condition characterized by the accumulation of non-purulent fluid in the middle ear space, in the absence of acute inflammation. OME is diagnosed 2.2 million times annually (U.S. Department of Health & Human Services, 2000). It is a condition in which more then 50% of children will experience in their first year of life (National Institutes of Health, 1993). Although many episodes resolve spontaneously, 30% to 40% persist, and 5% to 10% of episodes last 1 year or longer (Yoshinaga-Itano, 1995). It is particularly more common among children between the ages of one and three years and in seasons where the prevalence of upper respiratory tract infections is high; with an incidence of 10% to 30%. It occurs frequently even up to the age of seven, with a prevalence of 3% to 8%(Fiellau et al, 1997; Fiellau et al, 1983; Lous et al, 1981; Teele et al, 1989).

OME is the most common cause of acquired hearing loss in childhood. Long-term hearing complications from OME are associated with linguistic, developmental, and social consequences; especially if the OME is bilateral and of long duration (Fiellau et al, 1983; Golz et al, 1998; Grace et al, 1990; Lous et al, 1995). The etiology of OME is uncertain; however, low-grade infection, poor eustachian tube function, formation of biofilms, and adenoidal infection or hypertrophy have all been suggested as possible etiologies (Faden et al, 1998; Hall-Stoodley et al, 2006).

Recently, there has been good scientific evidence to suggest that OME is a supraesophageal manifestation of gastroesophageal reflux disease (GERD), and more specifically laryngo-pharyngeal reflux (LPR). Tasker et al (2002) investigated the potential role of gastric reflux in the development of OME in children who underwent myringotomy. Of 65 tested effusion samples, 59 (91%) effusions gave a positive result. The concentrations of pepsin/pepsinogen were roughly estimated to be about 1000 times higher than those found in the serum obtained from a number of controls. They speculated that pepsin found in middle ear effusion (MEE) was most probably due to micro-aspiration of gastric contents passing through the eustachian tube (ET) and reaching the middle ear. Lieu et al (2005) performed a pilot study where they replicated the finding of pepsin/pepsinogen in 17 of 36 (77%) middle ear fluid aspirates, obtained from 22 children who underwent tympanostomy tube placement for chronic or recurrent otitis media (OM).

Based on our literature review, we believe there is sufficient scientific evidence to support the empiric treatment of suspected GERD and LPR in patients with OME. Empiric anti-reflux therapy is a safe, proven, cost-effective diagnostic and treatment strategy used widely in the presence of other signs and symptoms of suspected GERD. This pilot study will be a double-blinded, randomized control trial. It will compare hearing outcomes for children with OME being treated with lansoprazole versus placebo for three months. We believe there is sufficient evidence to support the use of this strategy in patients with suspected GERD and LPR who present with OME.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Otitis Media With Effusion
Intervention  ICMJE
  • 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.
    Other Name: Prevacid
  • Drug: Placebo
    Lactose powder in 8.4% Sodium Bicarbonate (Liquid placebo)
Study Arms  ICMJE
  • Experimental: Lansoprazole
    Intervention: Drug: Lansoprazole
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 12, 2015)
Original Estimated Enrollment  ICMJE
 (submitted: March 4, 2010)
Actual Study Completion Date  ICMJE June 2014
Actual Primary Completion Date June 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT01082029
Other Study ID Numbers  ICMJE 07-435
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gavin Rukholm, McMaster University
Study Sponsor  ICMJE Hamilton Health Sciences Corporation
Collaborators  ICMJE McMaster University
Investigators  ICMJE
Principal Investigator: Dr. Diane Reid, MD FRCSC McMaster University
Principal Investigator: Dr. Gavin Rukholm, MD McMaster University
PRS Account McMaster University
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP