Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Colorado, Denver
• Collaborator: Genentech, Inc.

Criteria

Inclusion Criteria:

• subjects from age 1 to 18 years who have undergone tube placement in the previous 9 months.

• subjects with middle-ear fluid on entry into the study will be required to have had a prior normal hearing test.

Exclusion Criteria:

• subjects with symptoms of an acute otitis media (otalgia or otorrhea), sensorineural hearing loss,cranio-facial syndromes, cystic fibrosis, prior ear surgery except tube placement, sensitivity to fluoroquinolones and presence of granulation tissue in the lumen of the tympanostomy tubes will be excluded.