Otitis Media With Effusion
Conditions
Keywords
otitis media with effusion, gastroesophageal reflux, ear infection, proton pump inhibitor
Brief 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.
Detailed 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.
Interventions
DRUGlansoprazole
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.
DRUGplacebo
Placebo Solutab in 15 and 30 mg dosages.
Sponsors
Doris Duke Charitable Foundation
TAP Pharmaceutical Products Inc.
Washington University School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear | 2 months |
| Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar | 2 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acoustic Reflectometry: Level of Risk as Defined by Manufacturer | 2 months | 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). |
| Number of Participants With Normal Type A Tympanometry | 2 months | 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. |
| Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire | 2 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Prevacid Prevacid SoluTab (15 or 30 mg tab) once daily for 2 months | 9 |
| Placebo Placebo SoluTab once daily for 2 months | 7 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Inability to schedule follow-up visit | 1 | 0 |
| Overall Study | Withdrawal by Subject | 3 | 0 |
Baseline characteristics
| Characteristic | Placebo | Prevacid | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 9 Participants | 16 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 5.45 years STANDARD_DEVIATION 1.32 | 4.82 years STANDARD_DEVIATION 1.98 | 5.10 years STANDARD_DEVIATION 1.86 |
| Region of Enrollment United States | 7 participants | 9 participants | 16 participants |
| Sex: Female, Male Female | 1 Participants | 5 Participants | 6 Participants |
| Sex: Female, Male Male | 6 Participants | 4 Participants | 10 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 9 | 0 / 7 |
| other Total, other adverse events | 0 / 9 | 0 / 7 |
| serious Total, serious adverse events | 0 / 9 | 0 / 7 |
Outcome results
Primary
Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar
Time frame: 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevacid | Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar | 1 participants |
| Placebo | Absence of Middle Ear Fluid by Pneumatic Otoscopy, LeftEar | 3 participants |
Primary
Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear
Time frame: 2 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Prevacid | Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear | 1 participants |
| Placebo | Absence of Middle Ear Fluid by Pneumatic Otoscopy, Right Ear | 0 participants |
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).
Time frame: 2 months
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Prevacid | Acoustic Reflectometry: Level of Risk as Defined by Manufacturer | 2.5 level of risk |
| Placebo | Acoustic Reflectometry: Level of Risk as Defined by Manufacturer | 3.5 level of risk |
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.
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevacid | Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire | 0 Participants |
| Placebo | Number of Participants With at Least 1 Symptoms of Reflux in the Past Week, Assessed by the Reflux Symptom Questionnaire | 0 Participants |
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.
Time frame: 2 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Prevacid | Number of Participants With Normal Type A Tympanometry | 0 Participants |
| Placebo | Number of Participants With Normal Type A Tympanometry | 0 Participants |