Acute Otitis Media, Ear Infection, Otitis Media
Conditions
Keywords
Ear Infections, Otitis Media
Brief summary
The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
Detailed description
Otitis media (OM) is one of the most common childhood disorders requiring physician care and has been associated with an alarming rise in prevalence. Certain children are prone to recurrent episodes of acute Otitis media (RAOM) and/or the development of chronic Otitis media with effusion (COME). Because medical therapy with antibiotics, antihistamines, decongestants and corticosteroids has no demonstrable efficacy, the mainstay of treatment is surgical intervention, which is quite expensive and exposes patients to risks of general anesthesia. The objective of this pilot study is to evaluate the efficacy of treatment with montelukast as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
Interventions
DRUGMontelukast
DRUGPlacebo
Sponsors
Merck Sharp & Dohme LLC
Deborah Gentile
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Months to 5 Years
Healthy volunteers
No
Inclusion criteria
* Aged 18 months to 5 years old. * Diagnosis of current AOM
Exclusion criteria
* Presence of primary or secondary immunodeficiency, craniofacial abnormality, cleft palate, anatomic predisposition, major congenital anomaly or syndrome, or severe systemic disease * Use of: * Any investigational medications within the past 30 days, systemic or oral or nasal steroids within the past 30 days * Accolate® in the past 7 days * Antibiotics within the past week, except for Zithromax®, which will be 21 days * Long acting second generation antihistamines (i.e., Claritin®, Clarinex®, Allegra® and Zyrtec®) within the past 72 hours. * No known allergy to either montelukast or amoxicillin/clavulanate * Have not responded to Augmentin® in the past
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Acute Otitis Media | 16 weeks |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Montelukast Treatment with montelukast for 4 months (4 mg per day)
Montelukast | 50 |
| Placebo Treatment with placebo for 4 months | 49 |
| Total | 99 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lack of Efficacy | 5 | 1 |
| Overall Study | Lost to Follow-up | 18 | 20 |
Baseline characteristics
| Characteristic | Montelukast | Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 50 Participants | 49 Participants | 99 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 50 participants | 49 participants | 99 participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 44 Participants |
| Sex: Female, Male Male | 26 Participants | 29 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 16 / 50 | 15 / 49 |
| serious Total, serious adverse events | 0 / 50 | 0 / 49 |
Outcome results
Primary
Incidence of Acute Otitis Media
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Montelukast | Incidence of Acute Otitis Media | 30 participants with AOM |
| Placebo | Incidence of Acute Otitis Media | 27 participants with AOM |