CompletedPhase 3

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

United States91 participantsStarted 2005-09-01

Plain-language 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).

Who can participate

Age range6 Years – 100 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of Subjects With Complete Normalization of Abnormal Tympanometry, Regardless of Additional Treatment

Timeframe: 6 weeks

Trial details

NCT IDNCT00279916

SponsorMayo Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2009-02

Results submitted2011-07-20

View on ClinicalTrials.gov More Otitis Media, Serous trials