A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children

Deborah Gentile99 enrolled

Overview

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)

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)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

Conditions

Acute Otitis Media Otitis Media Ear Infection

Interventions

MontelukastDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 MonthsMax age: 5 Years

Medical Language ↔ Plain English

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

Locations (2)

Bellevue Pediatric Associates

Bellevue, Pennsylvania, United States

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

Incidence of Acute Otitis Media

Time frame: 16 weeks

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.