Clinical trial NCT00419380: Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)
Official title: Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Otitis Media
Keywords: clogged ear tubes
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-01-08
Enrollment: 40
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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.

Primary outcomes:
measure: Patency of the Tympanostomy Tube at the Day-14 Visit.
timeFrame: 14 days
Secondary outcomes:
measure: Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit.
timeFrame: 14 days
Other outcomes:
Locations:
city: Denver
country: United States
facility: The Children's Hospital
state: Colorado
Study officials:
affiliation: The Children's Hospital
name: Kenny H Chan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chan KH, Allen GC, Kelley PE, Streubel SO, Friedman NR, Yoon P, Gao D, Ruiz AG, Jung TTK. Dornase Alfa Ototoxic Effects in Animals and Efficacy in the Treatment of Clogged Tympanostomy Tubes in Children: A Preclinical Study and a Randomized Clinical Trial. JAMA Otolaryngol Head Neck Surg. 2018 Sep 1;144(9):776-780. doi: 10.1001/jamaoto.2018.1101.