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

Otitis Media Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00419380
• Other study ID #: 06-0556
• Secondary ID: BB-IND Number: 1
• Status: Completed
• Phase: Phase 4
• First received: January 4, 2007
• Last updated: March 11, 2015
• Start date: January 2007
• Est. completion date: May 2011

Study information

• Verified date: March 2015
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 18 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis Media

Intervention

Drug:
• dornase alfa (Pulmozyme®)
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.

Locations

Country	Name	City	State
United States	The Children's Hospital	Denver	Colorado

Sponsors (2)

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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patency of the Tympanostomy Tube at the Day-14 Visit.		14 days	No
Secondary	Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit.	Outcome measure data table represents the absence of drainage at day- 14	14 days	No