Effect of Simethicone on Eustachian Tube Dysfunction

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.

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