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

Completed · Phase 4

Conditions studied: Otitis Media

In brief

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 facts

Study ID

NCT00419380

Run by

University of Colorado, Denver

People needed

41

Starts

2007-01-01

Expected to finish

2011-05-01

Last updated by the study team

2026-06-08

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The Children's Hospital — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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