Overview
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
Status:
Completed
Completed
Trial end date:
2009-03-01
2009-03-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Mayo ClinicCollaborator:
Aventis PharmaceuticalsTreatments:
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