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

Mayo Clinic

Status and phase: Completed; Phase 3

Conditions: Otitis Media With Effusion; Rhinitis; Otitis Media, Serous; Otitis Media, Secretory; Negative Middle Ear Pressure

Treatments: Drug: Placebo nasal spray; Drug: Triamcinolone acetonide nasal spray

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00279916

IST4008 (Other Grant/Funding Number)

103-04

Details and patient eligibility

About

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).

Full 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.

Enrollment: 91 patients

Sex: All

Ages: 6 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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91 participants in 2 patient groups

Triamcinolone acetonide

Active Comparator group

Description:

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.

Treatment:

Drug: Triamcinolone acetonide nasal spray

Placebo

Sham Comparator group

Description:

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.

Treatment:

Drug: Placebo nasal spray