A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Overview
- Phase
- Phase 4
- Intervention
- Montelukast
- Conditions
- Acute Otitis Media
- Sponsor
- Deborah Gentile
- Enrollment
- 99
- Locations
- 2
- Primary Endpoint
- Incidence of Acute Otitis Media
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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)
Investigators
Deborah Gentile
Co- Investigator, Asthma & Allergy Dept
West Penn Allegheny Health System
Eligibility Criteria
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
- •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
Arms & Interventions
Montelukast
Treatment with montelukast for 4 months (4 mg per day)
Intervention: Montelukast
Placebo
Treatment with placebo for 4 months
Intervention: Placebo
Outcomes
Primary Outcomes
Incidence of Acute Otitis Media
Time Frame: 16 weeks