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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
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, 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

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Complete Normalization [ Time Frame: 6 weeks ]
    Type A tympanogram in both ears

Secondary Outcome Measures:
  • Complete Normalization, Including Treatment Failures [ Time Frame: 6 weeks ]
    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

  Show Detailed Description


Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Patients with serous otitis media and/or negative middle ear pressure will be considered for enrollment.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Study First Received: January 18, 2006
Results First Received: July 20, 2011
Last Updated: July 20, 2011

Additional relevant MeSH terms:
Otitis Media
Otitis Media with Effusion
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Ear Diseases
Triamcinolone hexacetonide
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017