Effect of Simethicone on Eustachian Tube Dysfunction

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Otitis Media

Intervention / Treatment
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* Drug: Simethicone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: simethicone<br>125 mg tablet | Drug: Simethicone<br>* single 125 mg chewable tablet<br>|
| Placebo Comparator: placebo<br>chewable calcium tablet | Drug: Placebo<br>* chewable calcium tablet<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eustachian tube, otitis, middle-ear pressure, simethicone