Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00419380
Status:
COMPLETED
Last Update Posted:
2015-03-27
First Post:
2007-01-04
Brief Title:
Treatment of Clogged Tympanostomy Tubes An Off-Label Use of Dornase Alfa Pulmozyme
Sponsor:
University of Colorado Denver
Organization:
University of Colorado Denver
Study Overview
Official Title:
Treatment of Clogged Tympanostomy Tubes An Off-Label Use of Dornase Alfa Pulmozyme
Status:
COMPLETED
Status Verified Date:
2015-03
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:
The purpose of this study is to evaluate Pulmozyme dornase as compared to a standard ear drop Floxin ofloxicin to dissolve clogged tubes This study will monitor the use of the new drug for any problems related to the medication Patients are being asked to be in this study because they had tubes placed for the treatment of chronic ear infection and the tubes are now clogged Clogged tubes are a common problem found in children with tubes This problem occasionally is improved with ear drops like Floxin However it is frequently not improved even after this standard ear drop treatment
Detailed Description:
The success in treating blocked tubes may relate to the ability to dissolve the material clogging the tube as well as dealing with the thick fluid in the middle-ear The reasoning behind this study is that the use of Pulmozyme may be able to treat both of these problems Pulmozyme was approved by the FDA in 1994 for the treatment of cystic fibrosis patients Infections present in airway lung secretions of cystic fibrosis patients and the material that plugs ear tubes are in some ways the same Off-label use of a drug is the practice by physicians to use a FDA-approved drug in treating conditions other than what the original approval was intended for Pulmozyme has been used to treat other lung diseases not related to cystic fibrosis There has been no published report on the use of Pulmozyme to treat ear infections This study is a clinical trial that compares two treatments and will last for 3 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| BB-IND Number 100242 | None | None | None |