Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)
| Status: | Archived |
|---|---|
| Conditions: | Other Indications, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Other |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 7/1/2011 |
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.
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.
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Children's Medical Center of Dallas Children's Medical Center is private, not-for-profit, and is the fifth-largest...
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