A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

Otitis Media With Effusion Clinical Trial

Official title:

A Clinical Trial of Proton Pump Inhibitors to Treat Children With Chronic Otitis Media With Effusion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00546117
• Other study ID #: HRPO# 07-0762
• Status: Completed
• Phase: N/A
• Start date: October 2007
• Est. completion date: December 2009

Study information

• Verified date: May 2018
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study is being done to see if reflux of stomach fluid might be a cause of chronic fluid in the ears. Our hypothesis is that treatment with an anti-reflux medication (lansoprazole) will increase the rate of resolution of chronic middle ear fluid in children.

Description:

This study is being done to see if reflux of stomach fluid might be a cause of fluid in the ears. Earlier studies have found pepsin or pepsinogen, a component of stomach fluid, in the middle ear fluid of many children with chronic middle ear fluid. Anti-reflux medicines called proton pump inhibitors (PPI) reduce the acidity of the contents of the stomach and the activity of pepsin or pepsinogen. We are studying the effectiveness of a PPI called lansoprazole (Prevacid™) in reducing fluid in the ears. If lansoprazole is able to reduce the fluid in the middle ear, this tells us that the reflux of gastric acid into the esophagus and into the ear canal may be causing middle ear fluid.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 12 Years

Eligibility

Inclusion Criteria:

• History of chronic otitis media with effusion meeting clinical indications for tympanostomy tubes placement, defined as the presence of middle ear fluid on physical exam for at least 3 months, in at least one ear.

Exclusion Criteria:

• Past medical history or concurrent conditions known to increase the incidence of either recurrent otitis media or otitis media with effusion or gastroesophageal reflux disease, including cleft palate, neurological delay, cerebral palsy, Down syndrome, velocardiofacial syndrome, and primary ciliary dyskinesia.

• Children with structural abnormalities of the tympanic membranes, such as cholesteatoma, deep retraction pockets, and atelectasis of the tympanic membrane. These abnormalities would require placement of tympanostomy tubes in standard clinical practice.

• Children weighing less than 10 kilograms, due to the lower weight limit for standard Prevacid™ dosing

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media with Effusion

Intervention

Drug:
• lansoprazole
Prevacid SoluTab 15 mg daily by mouth for 2 months (patients weighing 10-30 kg),or Prevacid SoluTab 30 mg daily by mouth for 2 months (patients weighing >30 kg) is the experimental arm. Placebo Solutabs will be given in the same dosage, frequency, and duration for the placebo arm.
• placebo
Placebo Solutab in 15 and 30 mg dosages.

Locations

Country	Name	City	State
United States	St. Louis Children's Hospital	Saint Louis	Missouri

Sponsors (3)

Lead Sponsor	Collaborator
Washington University School of Medicine	Doris Duke Charitable Foundation, TAP Pharmaceutical Products Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Abd El-Fattah AM, Abdul Maksoud GA, Ramadan AS, Abdalla AF, Abdel Aziz MM. Pepsin assay: a marker for reflux in pediatric glue ear. Otolaryngol Head Neck Surg. 2007 Mar;136(3):464-70. — View Citation

Lieu JE, Muthappan PG, Uppaluri R. Association of reflux with otitis media in children. Otolaryngol Head Neck Surg. 2005 Sep;133(3):357-61. — View Citation

Sone M, Yamamuro Y, Hayashi H, Yanagi E, Niwa Y, Nakashima T. Prediction of gastroesophageal reflux in otitis media with effusion in adults. Acta Otolaryngol. 2007 May;127(5):470-3. — View Citation

Tasker A, Dettmar PW, Panetti M, Koufman JA, P Birchall J, Pearson JP. Is gastric reflux a cause of otitis media with effusion in children? Laryngoscope. 2002 Nov;112(11):1930-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear		2 months
Primary	Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar		2 months
Secondary	Acoustic Reflectometry: Level of Risk as Defined by Manufacturer	Spectral gradient acoustic reflectometry is a noninvasive, non-audible acoustic wave used to help detect middle ear fluid. The manufacturer recommends interpretation of the angle result as: <49°, high risk of middle ear effusion (level 5); 49-59°, moderate-high risk (level 4); 60-69°, moderate risk (level 3); 70-95°, low-moderate risk (level 2) and >95°, low risk (level 1).	2 months
Secondary	Number of Participants With Normal Type A Tympanometry	Tympanometry of both ears, coded by Jerger classification (Type A, normal; type B, flat; Type C; negative pressure).; This is a standard test of middle ear status as performed by audiologists. Please refer to the reference for more information: Kileny & Zwolan, Diagnostic Audiology, chapter 133, Cummings Otolaryngology-Head and Neck Surgery, Elsevier/Saunders, 2015.	2 months
Secondary	Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire	Questions regarding reflux symptoms, created and evaluated by Nelson et al, Prevalence of symptoms of gastroesophageal reflux during childhood: a pediatric practice-based survey, Arch Pediatr Adolesc Med 2000;154;150-154. This study used the GER3-9P version for children aged 3-9 years. Results are reported as number reporting at least one specific symptom in the past week, maximum 7 symptoms.	2 months