Otitis Media
Conditions
Keywords
Eustachian tube, otitis, middle-ear pressure, simethicone
Brief summary
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
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.
Interventions
DRUGSimethicone
single 125 mg chewable tablet
DRUGPlacebo
chewable calcium tablet
Sponsors
University of Pittsburgh
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment | The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow |
Countries
United States
Participant flow
Recruitment details
Recruitment began in March 2011 and was terminated in March 2013. Recruitment was done by advertisement in the community.
Pre-assignment details
Ninety subjects (31 males, 59 females)were screened; 25 subjects entered the randomization phase.
Participants by arm
| Arm | Count |
|---|---|
| Simethicone 125 mg tablet
Simethicone: single 125 mg chewable tablet | 13 |
| Placebo chewable calcium tablet
Placebo: chewable calcium tablet | 12 |
| Total | 25 |
Baseline characteristics
| Characteristic | Simethicone | Total | Placebo |
|---|---|---|---|
| Age, Continuous | 27.1 years STANDARD_DEVIATION 9.1 | 29.8 years STANDARD_DEVIATION 10.6 | 32.8 years STANDARD_DEVIATION 11.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 11 Participants | 20 Participants | 9 Participants |
| Region of Enrollment United States | 13 participants | 25 participants | 12 participants |
| Sex: Female, Male Female | 9 Participants | 19 Participants | 10 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 13 | 0 / 12 |
| serious Total, serious adverse events | 0 / 13 | 0 / 12 |
Outcome results
Primary
Fraction of Middle Ear (ME) Pressure Equilibrated (FGE)
The proportion of the pressure chamber-ME pressure gradient equilibrated with 1 swallow
Time frame: After achieving the desired ME-pressure chamber gradient at baseline and 30 min post treatment
Population: ears pre-treatment/ears post-treatment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Simethicone-treated | Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Pre treatment FGE at -200 daPa | 0.17 ratio | Standard Deviation 0.28 |
| Simethicone-treated | Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | post-treatment FGE at -200 daPa | 0.19 ratio | Standard Deviation 0.28 |
| Simethicone-treated | Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Pre -treatment FGE at 200 daPa | 0.24 ratio | Standard Deviation 0.31 |
| Simethicone-treated | Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Post-treatment FGE at 200 daPa | 0.24 ratio | Standard Deviation 0.29 |
| Placebo | Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Post-treatment FGE at 200 daPa | 0.34 ratio | Standard Deviation 0.37 |
| Placebo | Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Pre treatment FGE at -200 daPa | 0.24 ratio | Standard Deviation 0.34 |
| Placebo | Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | Pre -treatment FGE at 200 daPa | 0.30 ratio | Standard Deviation 0.34 |
| Placebo | Fraction of Middle Ear (ME) Pressure Equilibrated (FGE) | post-treatment FGE at -200 daPa | 0.23 ratio | Standard Deviation 0.32 |
Comparison: Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of -200 daPa.p-value: =0.93Paired T-test
Comparison: Comparison of the simethicone and placebo groups with respect to the difference between the pre-post treatment FGE at ME-pressure chamber gradient of 200 daPa.p-value: =0.39Paired T-test