At a glance
ClinicalIndex Comparison Record- ✓Male or female, age 0-18 years
- ✓Serous otitis media and/or negative middle ear pressure documented by otoscopic examination and tympanometry
- ✕Unwilling to discontinue breast feeding, when applicable
- ✕Active upper respiratory infection
- ✕Nasopharyngeal mass
- ✕Chronic infectious otitis media
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays: a Randomized Placebo-controlled Study
In Brief
A Phase 3 clinical trial evaluating Triamcinolone acetonide nasal spray and Placebo nasal spray for Otitis Media, Serous and 4 related conditions. Completed, enrolled 91 participants across 1 site.
Detailed 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).
Study Details
Timeline
Interventions
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.