Overview

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

Status:
Completed
Trial end date:
2009-03-01
Target enrollment:
0
Participant gender:
All
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).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Mayo Clinic
Collaborator:
Aventis Pharmaceuticals
Treatments:
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Triamcinolone hexacetonide
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