Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
Otitis Media, Serous, Negative Middle Ear Pressure, Rhinitis
About this trial
This is an interventional treatment trial for Otitis Media, Serous
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
Sites / Locations
- Mayo Clinic
Arms of the Study
Arm 1
Arm 2
Active Comparator
Sham Comparator
Triamcinolone acetonide
Placebo
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.
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.