Phase 4
Completed N=41
Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)
Source: ClinicalTrials.gov NCT00419380 ↗Enrolled (actual)
41
Serious AEs
0.0%
Results posted
Mar 2015
Primary outcomePrimary: Patency of the Tympanostomy Tube at the Day-14 Visit. — 8; 11; 15; 12 Ear — p=.36
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patency of the Tympanostomy Tube at the Day-14 Visit. |
8; 11; 15; 12 | .36 |
| SECONDARY Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit. |
8; 11; 15; 12 | .26 |
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.
Data sourced from ClinicalTrials.gov (NCT00419380). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.