Acute Otitis Media: Adjuvant Therapy to Improve Outcome

This study has been completed.

First Received: November 2, 1999 Last Updated: April 21, 2006 History of Changes

Sponsored by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by:	National Institute on Deafness and Other Communication Disorders (NIDCD)
ClinicalTrials.gov Identifier:	NCT00000363

Purpose

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.

Condition	Intervention	Phase
Otitis Media	Drug: Antihistamine Drug: Corticosteroid	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Cold and Cough Medicines Ear Infections

Drug Information available for: Histamine Histamine phosphate Histamine dihydrochloride Corticosteroids

U.S. FDA Resources

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Estimated Study Completion Date:

June 2001

Eligibility

Ages Eligible for Study:	2 Months to 1 Year
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00000363

Locations

United States, Texas
Univ of Texas Med Branch Children's Hosp
Galveston, Texas, United States, 77550

Sponsors and Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

Study Chair:

Dr. Tasnee Chonmaitree

More Information

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.

Study ID Numbers:	NIDCD-1160, RO1 DC 02620-04
Study First Received:	November 2, 1999
Last Updated:	April 21, 2006
ClinicalTrials.gov Identifier:	NCT00000363 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Antibiotics
Adrenal Cortex Hormones
Histamine H1 Antagonists
Infant
Otitis Media

Study placed in the following topic categories:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Otitis Media
Adjuvants, Immunologic
Ear Diseases
Hormones
Histamine

Anti-Bacterial Agents
Histamine Antagonists
Otitis
Histamine H1 Antagonists
Histamine phosphate
Epinephrine

Additional relevant MeSH terms:

Neurotransmitter Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Histamine Antagonists
Otitis
Physiological Effects of Drugs

Otitis Media
Histamine Agents
Histamine H1 Antagonists
Ear Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 02, 2009