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

Phase 4

Completed

• Conditions: Otitis Media; Ear Infection; Acute Otitis Media
• Interventions: Drug: Placebo; Drug: Montelukast

• Registration Number: NCT00189462
• Lead Sponsor: Deborah Gentile

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)

Study Timeline

• Study Start: 2004-03
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2005-12
• Study Completion: 2005-12
• Results First Submitted: 2014-09-23
• Results First Submitted QC: 2014-10-06
• Results First Posted: 2014-10-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-30
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Treatment with placebo for 4 months
Montelukast	Montelukast	Treatment with montelukast for 4 months (4 mg per day)

Primary Outcome Measures

Name	Time	Method
Incidence of Acute Otitis Media	16 weeks

Trial Locations

Locations (2)

Bellevue Pediatric Associates; 🇺🇸 Bellevue, Pennsylvania, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States