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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00419380
First Posted: January 8, 2007
Last Update Posted: March 27, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Genentech, Inc.
Information provided by (Responsible Party):
University of Colorado, Denver
  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
Intervention Model: Parallel Assignment
Masking: Single (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:
  • Patency of the Tympanostomy Tube at the Day-14 Visit. [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • 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 ]
    Outcome measure data table represents the absence of drainage at day- 14


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®)
dornase alfa - Pulmozyme®: 5 drops twice daily for 7 days to the affected ear.
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
Ofloxin : 5 drops twice daily for 7 days to the affected ear.
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

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT00419380     History of Changes
Other Study ID Numbers: 06-0556
BB-IND Number: 100242
First Submitted: January 4, 2007
First Posted: January 8, 2007
Results First Submitted: February 24, 2015
Results First Posted: March 27, 2015
Last Update Posted: March 27, 2015
Last Verified: March 2015

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

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