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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 (Responsible Party):
Laura Orvidas, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00279916
First received: January 18, 2006
Last updated: April 19, 2017
Last verified: April 2017
  Purpose
We hypothesize that intranasal steroid application will have a beneficial therapeutic effect in adults with regard to resolution of serous otitis media and/or negative middle ear pressure, as compared to placebo. We further hypothesize that the rate of spontaneous short-term resolution of otitis media wit effusion in adults treated with placebo will be relatively low (minority of patients).

Condition Intervention Phase
Otitis Media, Serous Negative Middle Ear Pressure Rhinitis Otitis Media With Effusion Otitis Media, Secretory Drug: Triamcinolone acetonide nasal spray Drug: Placebo nasal spray Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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 Laura Orvidas, Mayo Clinic:

Primary Outcome Measures:
  • Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment [ Time Frame: 6 weeks ]
    Number of subjects with resolution of eustachian tube dysfunction symptoms, as determined by the change in tympanogram type in both ears from an initial Type B or C result to Type A result at 6 weeks. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure.


Secondary Outcome Measures:
  • Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution [ Time Frame: 6 weeks ]
    For this outcome measure, the subjects treated with antibiotics or oral decongestants while enrolled in the study were handled as having treatment failures. For this outcome measure, subjects with complete normalization of abnormal tympanometry at 6 weeks had a Type A tympanogram and did not take antibiotics, oral decongestants, nasal spray or a combination.

  • Per-Ear Treatment Outcome [ Time Frame: baseline, 6 weeks ]
    Initial Tympanogram Type at baseline was compared to Follow-Up Tympanogram Type at 6 weeks. Type A is considered to be normal. Type A; peaked pressure measurement under -100 kilo Pascals (kPa). Type B; non-peaked, or flat tympanogram, Type C; peaked pressure measurements more negative than -100 kPa. A Pascal is a unit used to quantify internal pressure.

  • Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears [ Time Frame: baseline, 6 weeks ]
    As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.

  • Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears [ Time Frame: baseline, 6 weeks ]
    As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.

  • Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears [ Time Frame: baseline, 6 weeks ]
    As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.

  • Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears [ Time Frame: baseline, 6 weeks ]
    As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.

  • Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual [ Time Frame: baseline, 6 weeks ]
    As measured by the Eustachian Tube Dysfunction Questionnaire. The questionnaire had 5 symptoms with a Frequency Rating from 1=Never to 5=Constantly, and Severity rating from 1=None at all to 5=Maximum severity. The change in frequency and severity ratings were categorized as same, better, or worse.


Enrollment: 91
Actual Study Start Date: September 1, 2005
Study Completion Date: March 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Triamcinolone acetonide

Triamcinolone acetonide nasal spray; Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms) for 6 weeks duration.

Subjects younger than 12 years old received received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms) for 6 weeks duration.

Drug: Triamcinolone acetonide nasal spray

Subjects aged 12 years or older received 2 metered sprays in each nostril once daily (55 micrograms/spray) (total daily dose 220 micrograms).

Subjects younger than 12 years old received received 1 metered spray in each nostril once daily (55 micrograms/spray) (total daily dose 110 micrograms).

Other Name: Nasacort AQ
Sham Comparator: Placebo

Placebo nasal spray; Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily for 6 weeks duration.

Subjects younger than 12 years old received received 1 metered spray of placebo solution in each nostril once daily for 6 weeks duration.

Drug: Placebo nasal spray

Subjects aged 12 years or older received an aqueous solution lacking triamcinolone, 2 metered sprays in each nostril once daily.

Subjects younger than 12 years old received received 1 metered spray of placebo solution in each nostril once daily.


Detailed Description:

Newer intranasal steroid preparations are generally safe with relatively few side effects as demonstrated in large studies dealing with allergic rhinitis.

Eustachian Tube Dysfunction (ETD) primarily refers to an absent or inadequate ability to open the eustachian tube. The term Serous Otitis Media (SOM) generally referring to an accumulation of fluid within the middle ear space, in absence of signs indicating acute infection. Commonly, this can result in a conductive hearing loss due to restriction of tympanic membrane mobility. Negative Middle Ear Pressure (NMEP) is often a precursor to the development of SOM, and has it's own effect on the acoustic properties of the middle ear, also resulting in conductive hearing loss.

Due to the lack of a single accepted medical intervention to deal with ETD and the general benign nature of this condition, it is common practice for some physicians to take a "wait and see" initial approach when this clinical entity is encountered in lieu of prescribing unproved medications. It is generally accepted that some patients with Negative Middle Ear Pressure (NMEP) and/or Serous Otitis Media (SOM) will undergo spontaneous resolution of symptoms, yet the exact resolution rates are not clearly defined.

The purpose of this double-blind, randomized study of either triamcinolone acetonide nasal spray or a sham placebo nasal spray for 6 weeks is to determine if there is improvement in a test of middle ear pressure. Neither the subjects nor the Investigator will know which of the two treatments is being used until the end of the study.

Resolution of ETD symptoms will be measured by changes in the tympanogram, a test to measure pressure within the middle ear. This measurement will be taken at baseline and after 6 weeks of treatment.

  Eligibility

Ages Eligible for Study:   6 Years to 100 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, age 0-18 years
  • Patients with serous otitis media and/or negative middle ear pressure as documented by otoscopic examination and tympanometry will be considered for enrollment
  • Pregnant

Exclusion Criteria:

  • Unwilling to discontinue breast feeding, when applicable
  • Active upper respiratory infection
  • Nasopharyngeal mass
  • Chronic infectious otitis media
  • Cholesteatoma
  • Acute infectious otitis media
  • History of otologic surgery other than placement of a pressure equalizer tube in the affected ear
  • History of radiation therapy to the head and neck region
  • Neuromuscular disease
  • Cystic fibrosis
  • Immunodeficiency
  • Mucociliary disorders
  • Craniofacial disorders/syndromes
  • Cleft palate
  • Development delay and/or symptoms suggestive of perilymph fistula
  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 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

Publications:
Responsible Party: Laura Orvidas, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00279916     History of Changes
Other Study ID Numbers: 103-04
IST4008 ( Other Grant/Funding Number: Sanofi-Aventis US, LLC )
Study First Received: January 18, 2006
Results First Received: July 20, 2011
Last Updated: April 19, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Rhinitis
Otitis
Otitis Media
Otitis Media with Effusion
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Ear Diseases
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anti-Inflammatory Agents
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 August 17, 2017