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Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)
Sponsor: University of Colorado, Denver
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 tube(s) 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.
Key Details
Gender
All
Age Range
1 Year - 18 Years
Study Type
INTERVENTIONAL
Enrollment
41
Start Date
2007-01
Completion Date
2011-05
Last Updated
2026-06-08
Healthy Volunteers
Yes
Conditions
Interventions
dornase alfa (Pulmozyme®)
This study will compare two treatment arms. Patients will be randomized to either traditional treatment (Ofloxin)or to experimental treatment \[dornase alfa (Pulmozyme®)\]. Each arm will have subjects instilling 5 drops twice daily for 7 days to the affected ear.
Locations (1)
The Children's Hospital
Denver, Colorado, United States