Otitis Media
Conditions
Keywords
clogged ear tubes
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.
Interventions
DRUGdornase 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.
Sponsors
University of Colorado, Denver
Genentech, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Patency of the Tympanostomy Tube at the Day-14 Visit. | 14 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit. | 14 days | Outcome measure data table represents the absence of drainage at day- 14 |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORKenny H Chan, MD
The Children's Hospital
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dornase Alfa (Pulmozyme®) 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. | 19 |
| Ofloxin 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. | 22 |
| Total | 41 |
Baseline characteristics
| Characteristic | Dornase Alfa (Pulmozyme®) | Ofloxin | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 19 Participants | 22 Participants | 41 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 4.45 years STANDARD_DEVIATION 3.3 | 4.05 years STANDARD_DEVIATION 2.27 | 4.24 years STANDARD_DEVIATION 2.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants | 1 Participants | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 21 Participants | 36 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) White | 19 Participants | 20 Participants | 39 Participants |
| Region of Enrollment United States | 19 participants | 22 participants | 41 participants |
| Sex: Female, Male Female | 6 Participants | 4 Participants | 10 Participants |
| Sex: Female, Male Male | 13 Participants | 18 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| other Total, other adverse events | 11 / 19 | 11 / 22 |
| serious Total, serious adverse events | 0 / 19 | 0 / 22 |
Outcome results
Primary
Patency of the Tympanostomy Tube at the Day-14 Visit.
Time frame: 14 days
Population: Analysis performed on ear level. Some participants received drops in both ears and thus both ears were included in analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dornase Alfa (Pulmozyme®) | Patency of the Tympanostomy Tube at the Day-14 Visit. | Right Ear | 8 Ear |
| Dornase Alfa (Pulmozyme®) | Patency of the Tympanostomy Tube at the Day-14 Visit. | Left Ear | 15 Ear |
| Ofloxin | Patency of the Tympanostomy Tube at the Day-14 Visit. | Right Ear | 11 Ear |
| Ofloxin | Patency of the Tympanostomy Tube at the Day-14 Visit. | Left Ear | 12 Ear |
Comparison: Two by two contingency table was used to compare our outcome, tube patency yes/no, by our two independent variables, dornase alfa (Pulmozyme®) and Ofloxin.p-value: 0.36Chi-squared
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
Time frame: 14 days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Dornase Alfa (Pulmozyme®) | Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit. | Right Ear | 8 Ear |
| Dornase Alfa (Pulmozyme®) | Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit. | Left Ear | 15 Ear |
| Ofloxin | Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit. | Right Ear | 11 Ear |
| Ofloxin | Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit. | Left Ear | 12 Ear |
p-value: 0.26Chi-squared