Acute Otitis Media: Adjuvant Therapy to Improve Outcome
Information source: National Institute on Deafness and Other Communication Disorders (NIDCD)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Otitis Media
Intervention: Antihistamine (Drug); Corticosteroid (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: National Institute on Deafness and Other Communication Disorders (NIDCD) Official(s) and/or principal investigator(s):
Dr. Tasnee Chonmaitree, Study Chair
Summary
Acute otitis media is one of the most common diseases of childhood and is one of the major
causes of hearing loss in children. Despite the availability of effective antibiotic therapy
for otitis media, treatment failures, persistent effusions, and recurrences are common. This
Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a
corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes
of patients with acute otitis media. This study is targeted to recruiting 200 infants (age
less than one year); patient (and parent) participation is estimated to continue for one year
after enrollment.
Clinical Details
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Eligibility
Minimum age: 2 Months.
Maximum age: 1 Year.
Gender(s): Both.
Criteria:
Inclusion Criteria:
Have had two documented prior episodes of acute otitis media.
Have no current middle ear effusion (fluid).
Exclusion Criteria:
Have chronic otitis media.
Have acute otitis media in addition to chronic otitis media.
Locations and Contacts
Univ of Texas Med Branch Children's Hosp, Galveston, Texas 77550, United States
Additional Information
Related publications: Chonmaitree T, Saeed K, Uchida T, Heikkinen T, Baldwin CD, Freeman DH Jr, McCormick DP. A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. J Pediatr. 2003 Sep;143(3):377-85. McCormick DP, Saeed K, Uchida T, Baldwin CD, Deskin R, Lett-Brown MA, Heikkinen T, Chonmaitree T. Middle ear fluid histamine and leukotriene B4 in acute otitis media: effect of antihistamine or corticosteroid treatment. Int J Pediatr Otorhinolaryngol. 2003 Mar;67(3):221-30.
Ending date: June 2001
Last updated: April 21, 2006
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