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

This study has been completed.
Aventis Pharmaceuticals
Information provided by:
Mayo Clinic Identifier:
First received: January 18, 2006
Last updated: July 20, 2011
Last verified: July 2011
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 Phase
Otitis Media, Serous
Negative Middle Ear Pressure
Drug: triamcinolone acetonide
Drug: placebo nasal spray
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays: a Randomized Placebo-controlled Study

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Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Complete Normalization [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Type A tympanogram in both ears

Secondary Outcome Measures:
  • Complete Normalization, Including Treatment Failures [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    Type A tympanogram and not taking antibiotics, oral decongestants, nasal spray or combo

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)
Arms Assigned Interventions
Active Comparator: TAA-AQ
Nasacort AQ nasal spray
Drug: triamcinolone acetonide
2 metered sprays in each nostril daily (55 mcg/spray)
Other Name: Nasacort AQ, Sanofi-Aventis
Sham Comparator: Placebo Drug: placebo nasal spray
aqueous solution lacking triamcinolone, 2 metered sprays in each nostril daily

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Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Patients with serous otitis media and/or negative middle ear pressure will be considered for enrollment.
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Please refer to this study by its identifier: NCT00279916

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Aventis Pharmaceuticals
Principal Investigator: Laura J. Orvidas, M.D. Mayo Clinic
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Laura J Orvidas, MD, Mayo Clinic Identifier: NCT00279916     History of Changes
Other Study ID Numbers: 103-04  XRG5029C/4008 
Study First Received: January 18, 2006
Results First Received: July 20, 2011
Last Updated: July 20, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
Anti-Inflammatory Agents
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs processed this record on May 26, 2016