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

This study has been completed.

First Received: January 18, 2006 Last Updated: March 27, 2009 History of Changes

Sponsor:	Mayo Clinic
Collaborator:	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

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

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections

Drug Information available for: Triamcinolone diacetate Triamcinolone acetonide Triamcinolone Triamcinolone hexacetonide

U.S. FDA Resources

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
Study Completion Date:	March 2009
Primary Completion Date:	February 2009 (Final data collection date for primary outcome measure)

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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
Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Aventis Pharmaceuticals

Investigators

Principal Investigator:

Laura J. Orvidas, M.D.

Mayo Clinic

More Information

No publications provided

Study ID Numbers:	103-04, XRG5029C/4008
Study First Received:	January 18, 2006
Last Updated:	March 27, 2009
ClinicalTrials.gov Identifier:	NCT00279916 History of Changes
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Otorhinolaryngologic Diseases
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Otitis Media with Effusion
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Otitis Media
Enzyme Inhibitors
Rhinitis
Triamcinolone diacetate
Immunosuppressive Agents

Hormones
Glucocorticoids
Ear Diseases
Pharmacologic Actions
Nose Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Respiratory Tract Diseases
Respiratory Tract Infections
Therapeutic Uses
Otitis
Triamcinolone

ClinicalTrials.gov processed this record on November 27, 2009