Status:
COMPLETED
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Aventis Pharmaceuticals
Conditions:
Otitis Media, Serous
Negative Middle Ear Pressure
Eligibility:
All Genders
6-100 years
Phase:
PHASE3
Brief 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...
Detailed Description
Newer intranasal steroid preparations are generally safe with relatively few side effects as demonstrated in large studies dealing with allergic rhinitis. Eustachian Tube Dysfunction (ETD) primarily ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2009
Estimated Enrollment :
91 Patients enrolled
Trial Details
Trial ID
NCT00279916
Start Date
September 1 2005
End Date
March 1 2009
Last Update
May 30 2017
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905