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Enzyme

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

Phase 4
Waitlist Available
Led By Kenny H Chan, MD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 14 days
Awards & highlights
Drug Has Already Been Approved
No Placebo-Only Group
Pivotal Trial
All Individual Drugs Already Approved

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.

Eligible Conditions
  • Chronic Otitis Media
  • Ear Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~14 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 14 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit.

Awards & Highlights

Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Trial Design

2Treatment groups
Active Control
Group I: dornase alfa (Pulmozyme®)Active Control1 Intervention
dornase alfa - Pulmozyme®: 5 drops twice daily for 7 days to the affected ear.
Group II: OfloxinActive Control1 Intervention
Ofloxin : 5 drops twice daily for 7 days to the affected ear.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,919,940 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,565 Previous Clinical Trials
569,960 Total Patients Enrolled
Kenny H Chan, MDPrincipal InvestigatorThe Children's Hospital
~2 spots leftby Jan 2026
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