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

This study has been completed.
Sponsor:
Collaborator:
Aventis Pharmaceuticals
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00279916
First received: January 18, 2006
Last updated: July 20, 2011
Last verified: July 2011
History of Changes
  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 Phase
Otitis Media, Serous
Negative Middle Ear Pressure
Rhinitis
 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

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   6 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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 by Mayo Clinic

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Laura J Orvidas, MD, Mayo Clinic
ClinicalTrials.gov 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
Otitis Media
Rhinitis
Otitis Media with Effusion
Ear Diseases
Otorhinolaryngologic Diseases
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
 Triamcinolone diacetate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2013