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| Brief Title † | Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®) | ||||||||
| Official Title † | Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®) | ||||||||
| 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 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. |
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| 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type † | Interventional | ||||||||
| Study Design † | Active Control, Double-Blind, Parallel Assignment, Randomized, Safety/Efficacy Study, Treatment | ||||||||
| Primary Outcome Measure † | The primary outcome of the study is patency of the tympanostomy tube at the day-14 visit. | ||||||||
| Secondary Outcome Measure † | The secondary outcomes of the study include the presence or absence of drainage in the ear canal and fluid in the middle ear at the the day-14 visit. | ||||||||
| Condition † | Otitis Media | ||||||||
| Intervention † | Drug: dornase alfa (Pulmozyme®) | ||||||||
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| Recruitment Information Fields | |||||||||
| Recruitment Status † | Recruiting | ||||||||
| Enrollment † | 40 | ||||||||
| Start Date † | January 2007 | ||||||||
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| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 1 Year to 18 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts †† |
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| Location Countries † | United States | ||||||||
| Administrative Information Fields | |||||||||
| NCT ID † | NCT00419380 | ||||||||
| Organization ID | Z3816s | ||||||||
| Secondary IDs †† | BB-IND Number: 100242 | ||||||||
| Study Sponsor † | The Children's Hospital, Denver | ||||||||
| Collaborators †† | Genentech | ||||||||
| Investigators † |
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| Information Provided By | The Children's Hospital, Denver | ||||||||
| Verification Date | January 2007 | ||||||||
| First Received Date † | January 4, 2007 | ||||||||
| Last Updated Date | January 4, 2007 | ||||||||
