CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 41 enrolled
Drug / intervention
dornase alfa (Pulmozyme®)drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00419380
NCT00419380Phase 4Completed
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Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)

University of Colorado, Denver·interventional·Posted Jan 8, 2007·Updated Jun 8, 2026

In Brief

A Phase 4 clinical trial evaluating dornase alfa (Pulmozyme®) for Otitis Media. Completed, enrolled 41 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOtitis Media
CountriesUnited States
CollaboratorsGenentech, Inc.

Timeline

Phase 4CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 8, 2007
Enrollment StartJan 1, 2007
Primary CompletionMay 1, 2011
TodayJul 2, 2026
Enrollment to primary: 4.3 yearsPosted 19.5 years ago

Interventions

dornase alfa (Pulmozyme®)drug

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.