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

Completed · Phase 3 · Has a placebo group

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

In brief

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).

Key facts

Study ID

NCT00279916

Run by

Mayo Clinic

People needed

91

Starts

2005-09-01

Expected to finish

2009-03-01

Last updated by the study team

2017-05-30

Who can join

Age: 6 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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