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NCT Number: NCT00279916

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

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).

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Key information

Conditions

Otitis Media, Serous Ear Diseases Infections Negative Middle Ear Pressure Nose Diseases OTITIS MEDIA WITH EFFUSION Otitis Otitis Media Otitis Media, Secretory Otorhinolaryngologic Diseases Respiratory Tract Diseases Respiratory Tract Infections Rhinitis

Age range

6 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Triamcinolone acetonide nasal spray

Drug

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 names: Nasacort AQ

Placebo nasal spray

Drug

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.

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Aventis Pharmaceuticals

Registry information

Official study title

Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays: a Randomized Placebo-controlled Study

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Jan 20, 2006
Registry last updated
May 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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