Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00279916
Status:
COMPLETED
Last Update Posted:
2017-05-30
First Post:
2006-01-18
Brief Title:
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays
Sponsor:
Mayo Clinic
Organization:
Mayo Clinic
Study Overview
Official Title:
Short Term Relief of Eustachian Tube Dysfunction and Serous Otitis Media Using Intranasal Steroid Sprays a Randomized Placebo-controlled Study
Status:
COMPLETED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We hypothesize that intranasal steroid application will have a beneficial therapeutic effect in adults with regard to resolution of serous otitis media andor 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
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 refers to an absent or inadequate ability to open the eustachian tube The term Serous Otitis Media SOM generally referring to an accumulation of fluid within the middle ear space in absence of signs indicating acute infection Commonly this can result in a conductive hearing loss due to restriction of tympanic membrane mobility Negative Middle Ear Pressure NMEP is often a precursor to the development of SOM and has its own effect on the acoustic properties of the middle ear also resulting in conductive hearing loss
Due to the lack of a single accepted medical intervention to deal with ETD and the general benign nature of this condition it is common practice for some physicians to take a wait and see initial approach when this clinical entity is encountered in lieu of prescribing unproved medications It is generally accepted that some patients with Negative Middle Ear Pressure NMEP andor Serous Otitis Media SOM will undergo spontaneous resolution of symptoms yet the exact resolution rates are not clearly defined
The purpose of this double-blind randomized study of either triamcinolone acetonide nasal spray or a sham placebo nasal spray for 6 weeks is to determine if there is improvement in a test of middle ear pressure Neither the subjects nor the Investigator will know which of the two treatments is being used until the end of the study
Resolution of ETD symptoms will be measured by changes in the tympanogram a test to measure pressure within the middle ear This measurement will be taken at baseline and after 6 weeks of treatment
Eustachian Tube Dysfunction ETD primarily refers to an absent or inadequate ability to open the eustachian tube The term Serous Otitis Media SOM generally referring to an accumulation of fluid within the middle ear space in absence of signs indicating acute infection Commonly this can result in a conductive hearing loss due to restriction of tympanic membrane mobility Negative Middle Ear Pressure NMEP is often a precursor to the development of SOM and has its own effect on the acoustic properties of the middle ear also resulting in conductive hearing loss
Due to the lack of a single accepted medical intervention to deal with ETD and the general benign nature of this condition it is common practice for some physicians to take a wait and see initial approach when this clinical entity is encountered in lieu of prescribing unproved medications It is generally accepted that some patients with Negative Middle Ear Pressure NMEP andor Serous Otitis Media SOM will undergo spontaneous resolution of symptoms yet the exact resolution rates are not clearly defined
The purpose of this double-blind randomized study of either triamcinolone acetonide nasal spray or a sham placebo nasal spray for 6 weeks is to determine if there is improvement in a test of middle ear pressure Neither the subjects nor the Investigator will know which of the two treatments is being used until the end of the study
Resolution of ETD symptoms will be measured by changes in the tympanogram a test to measure pressure within the middle ear This measurement will be taken at baseline and after 6 weeks of treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IST4008 | OTHER_GRANT | Sanofi-Aventis US LLC | None |