Effect of Simethicone on Eustachian Tube Dysfunction

A Pilot Study of the Effect of Simethicone in Adult Subjects With a Common Cold on Eustachian Tube Dysfunction

This study is designed to measure the effects of a chewable Simethicone tablet taken by mouth on middle-ear pressure in adults with a common cold and evidence of abnormal middle-ear pressure. In children and adults, middle-ear diseases such as otitis media (the buildup of fluid within the middle ear) and a form of temporary hearing loss occur if the Eustachian tube does not open, does not open often enough or is always open. Simethicone, available over-the-counter under several brand names including Gas-X, may help break up the bubbles that may block the opening of the Eustachian tube in the back of the nose during a cold, allowing air to pass between the nose and middle ear. This study requires a single visit to the Middle Ear Physiology Laboratory in the Oakland section of Pittsburgh. If eligible for the study, Eustachian tube function testing will be done; the Simethicone tablet or placebo (a tablet that looks and tastes like the Simethicone tablet but has no active ingredient) will be given and Eustachian tube function testing repeated.

Study Overview

• Status: Completed
• Conditions: Otitis Media
• Intervention / Treatment: Drug: Simethicone; Drug: Placebo

Detailed Description

For the Eustachian tube function testing, the subject and a technician are seated comfortably within a pressure chamber, a room-like chamber in which the air pressure can be varied much like in an airplane or submarine. Middle ear pressure will be measured in each ear by tympanometry, a test done by inserting a small probe (an earplug attached to a rubber or plastic tube that measures ear pressure) half-way into the ear canal and changing the pressure in the probe. Then, microphones will be placed in the ear canals and a sound source placed into one nostril. The chamber pressure is then decreased and increased to various pressures and middle ear pressure is measured at these various pressures.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • Middle Ear Physiology Laboratory of Children's Hospital of PIttsburgh of UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age 18 to 50 years
• Healthy subjects other than current upper respiratory tract infection ("cold")
• Jackson Score of 6 on screening
• Subject reports symptom onset within 4 days of entry visit
• Unilateral or bilateral middle-ear pressure <-50 mmH2O

Exclusion Criteria:

• Otoscopic diagnosis of unilateral or bilateral otitis media
• Presence of tympanostomy tubes or tympanic membrane perforations bilaterally
• Asthma or any chronic medical disease or condition
• Use of an "over the counter" medicine within 24 hours of study or prescription within 4 weeks of the study day (except birth control)
• Use of an experimental drug within 3 months of study
• An unusual or allergic reaction to simethicone, food dyes, or preservatives
• Pregnancy or breast feeding
• Ear surgery other than tympanostomy tube insertion

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: simethicone; 125 mg tablet	Drug: Simethicone; single 125 mg chewable tablet
Placebo Comparator: placebo; chewable calcium tablet	Drug: Placebo; chewable calcium tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)	The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow	After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment

Collaborators and Investigators

• Sponsor: University of Pittsburgh
• Investigators: Principal Investigator: William J Doyle, PhD, Department of Otolaryngology, Children's Hospital of Pittsburgh of UPMC

Study record dates

Study Major Dates

• Study Start: March 1, 2011
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: March 9, 2011
• First Submitted That Met QC Criteria: March 9, 2011
• First Posted (Estimate): March 10, 2011

Study Record Updates

• Last Update Posted (Estimate): June 27, 2016
• Last Update Submitted That Met QC Criteria: June 23, 2016
• Last Verified: June 1, 2016

More Information

Terms related to this study

• Keywords: simethicone; Eustachian tube; otitis; middle-ear pressure
• Additional Relevant MeSH Terms: Otorhinolaryngologic Diseases; Ear Diseases; Otitis; Otitis Media; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents; Antifoaming Agents; Emollients; Simethicone
• Other Study ID Numbers: PRO011010385