Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
Condition: Otitis Media, Serous; Negative Middle Ear Pressure; Rhinitis; Otitis Media With Effusion; Otitis Media, Secretory
MeSH terms: Rhinitis; Otitis; Otitis Media; Otitis Media with Effusion
Study type: Interventional
Phase: Phase 3

Summary: 
      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).
    

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.
    

Intervention name(s): Triamcinolone acetonide nasal spray; Placebo nasal spray
Intervention type(s): Drug; Drug
Intervention description(s): 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).; 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.
Other intervention name(s): Nasacort AQ
Intervention MeSH terms: Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment