Clinical trial NCT00279916: Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
Official title: Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays: a Randomized Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Otitis Media, Serous
Negative Middle Ear Pressure
Rhinitis
Otitis Media With Effusion
Otitis Media, Secretory
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
First posted: 2006-01-20
Enrollment: 91
Sex: ALL
Minimum age (years): 6
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment
timeFrame: 6 weeks
Secondary outcomes:
measure: Complete Normalization of Abnormal Tympanometry Considering the Subjects Who Took Additional Treatment as Having Incomplete Resolution
timeFrame: 6 weeks
measure: Per-Ear Treatment Outcome
timeFrame: baseline, 6 weeks
measure: Number of Subjects With Change in Symptom Frequency and Severity - Fullness or Pressure in Ears
timeFrame: baseline, 6 weeks
measure: Number of Subjects With Change in Symptom Frequency and Severity - Pain in Ears
timeFrame: baseline, 6 weeks
measure: Number of Subjects With Change in Symptom Frequency and Severity - Plugged Sensation in Ears
timeFrame: baseline, 6 weeks
measure: Number of Subjects With Change in Symptom Frequency and Severity - Popping Sensation in Ears
timeFrame: baseline, 6 weeks
measure: Number of Subjects With Change in Symptom Frequency and Severity - Dampened Hearing/Loss Worse Than Usual
timeFrame: baseline, 6 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Laura J. Orvidas, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gluth MB, McDonald DR, Weaver AL, Bauch CD, Beatty CW, Orvidas LJ. Management of eustachian tube dysfunction with nasal steroid spray: a prospective, randomized, placebo-controlled trial. Arch Otolaryngol Head Neck Surg. 2011 May;137(5):449-55. doi: 10.1001/archoto.2011.56.