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

This study has been completed.
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT00419380
First received: January 4, 2007
Last updated: March 5, 2013
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Otitis Media
Drug: dornase alfa (Pulmozyme®)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • The primary outcome of the study is patency of the tympanostomy tube at the day-14 visit. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The secondary outcomes of the study include the presence or absence of drainage in the ear canal and fluid in the middle ear at the the day-14 visit. [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: January 2007
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: dornase alfa (Pulmozyme®) 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.
Active Comparator: Ofloxin 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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00419380

Locations
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
Sponsors and Collaborators
University of Colorado, Denver
Genentech, Inc.
Investigators
Principal Investigator: Kenny H Chan, MD The Children's Hospital
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00419380     History of Changes
Other Study ID Numbers: 06-0556, BB-IND Number: 100242
Study First Received: January 4, 2007
Last Updated: March 5, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Colorado, Denver:
clogged ear tubes

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otitis
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014