Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays - Full Text View

Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays

This study is currently recruiting participants.
Verified by Mayo Clinic, January 2006

Sponsors and Collaborators:	Mayo Clinic Aventis Pharmaceuticals
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00279916

Purpose

We hypothesize that intranasal steroid application will have a beneficial therapeutic effect in adults with regard to resolution of SOM and/or NMEP as compared to placebo. We further hypothesize that the rate of spontaneous short-term resolution of OME in adults treated with placebo will be relatively low (minority of patients).

Condition	Intervention
Otitis Media, Serous Negative Middle Ear Pressure Rhinitis	Drug: triamcinolone acetonide

MedlinePlus related topics:

Ear Infections

Drug Information available for:

Triamcinolone acetonide Triamcinolone Triamcinolone diacetate Triamcinolone hexacetonide

U.S. FDA Resources

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

Official Title:	Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays: a Randomized Placebo-Controlled Study

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Study Questionnaires @ baseline and 6 weeks
Otorhinolaryngologic examination @ baseline and 6 weeks
Pure-tone audiometric assessments and tympanogram @ baseline and 6 weeks

Estimated Enrollment:	146
Study Start Date:	September 2005

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both

Criteria

Patients with serous otitis media and/or negative middle ear pressure will be considered for enrollment.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00279916

Locations


United States, Minnesota
	Mayo Clinic	Recruiting
	Rochester, Minnesota, United States, 55905
	Contact: Melissa M Westergren 507-538-1392 westergren.melissa@mayo.edu
	Principal Investigator: Laura J Orvidas, MD

Sponsors and Collaborators

Mayo Clinic

Aventis Pharmaceuticals

Investigators


Principal Investigator:	Laura J. Orvidas, M.D.	Mayo Clinic

More Information

Study ID Numbers:	103-04, XRG5029C/4008
First Received:	January 18, 2006
Last Updated:	January 18, 2006
ClinicalTrials.gov Identifier:	NCT00279916
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Triamcinolone Acetonide

Otorhinolaryngologic Diseases

Respiratory Tract Infections

Respiratory Tract Diseases

Otitis Media with Effusion

Otitis

Triamcinolone

Otitis Media

Triamcinolone diacetate

Rhinitis

Ear Diseases

Triamcinolone hexacetonide

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Immunologic Factors

Therapeutic Uses

Physiological Effects of Drugs

Hormones, Hormone Substitutes, and Hormone Antagonists

Enzyme Inhibitors

Immunosuppressive Agents

Hormones

Glucocorticoids

Pharmacologic Actions

Nose Diseases

ClinicalTrials.gov processed this record on October 24, 2008