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

Deborah Gentile

Status and phase: Completed; Phase 4

Conditions: Acute Otitis Media; Ear Infection; Otitis Media

Treatments: Drug: Montelukast; Drug: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00189462

RC - 3643

Details and patient eligibility

About

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)

Full 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)

Enrollment: 99 patients

Sex: All

Ages: 18 months to 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

99 participants in 2 patient groups, including a placebo group

Montelukast

Active Comparator group

Description:

Treatment with montelukast for 4 months (4 mg per day)

Treatment:

Drug: Montelukast

Placebo

Placebo Comparator group

Description:

Treatment with placebo for 4 months

Treatment:

Drug: Placebo