Trial Outcomes & Findings for Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®) (NCT NCT00419380)
NCT ID: NCT00419380
Last Updated: 2015-03-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
40 participants
Primary outcome timeframe
14 days
Results posted on
2015-03-27
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
19
|
22
|
|
Overall Study
COMPLETED
|
18
|
12
|
|
Overall Study
NOT COMPLETED
|
1
|
10
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lack of Efficacy
|
1
|
7
|
|
Overall Study
Physician Decision
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)
Baseline characteristics by cohort
| Measure |
Dornase Alfa (Pulmozyme®)
n=19 Participants
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.
|
Ofloxin
n=22 Participants
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.
|
Total
n=41 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
19 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
41 Participants
n=27 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Age, Continuous
|
4.45 years
STANDARD_DEVIATION 3.30 • n=93 Participants
|
4.05 years
STANDARD_DEVIATION 2.27 • n=4 Participants
|
4.24 years
STANDARD_DEVIATION 2.80 • n=27 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=93 Participants
|
21 Participants
n=4 Participants
|
36 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=93 Participants
|
22 participants
n=4 Participants
|
41 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 14 daysPopulation: Analysis performed on ear level. Some participants received drops in both ears and thus both ears were included in analysis.
Outcome measures
| Measure |
Dornase Alfa (Pulmozyme®)
n=19 Participants
dornase alfa (Pulmozyme®): 5 drops twice daily for 7 days to the affected ear. Right ear n=8; Left ear n= 15
|
Ofloxin
n=18 Participants
Ofloxin: 5 drops twice daily for 7 days to the affected ear. Right ear n=11; Left ear n=12
|
|---|---|---|
|
Patency of the Tympanostomy Tube at the Day-14 Visit.
Right Ear
|
8 Ear
|
11 Ear
|
|
Patency of the Tympanostomy Tube at the Day-14 Visit.
Left Ear
|
15 Ear
|
12 Ear
|
SECONDARY outcome
Timeframe: 14 daysOutcome measure data table represents the absence of drainage at day- 14
Outcome measures
| Measure |
Dornase Alfa (Pulmozyme®)
n=19 Participants
dornase alfa (Pulmozyme®): 5 drops twice daily for 7 days to the affected ear. Right ear n=8; Left ear n= 15
|
Ofloxin
n=18 Participants
Ofloxin: 5 drops twice daily for 7 days to the affected ear. Right ear n=11; Left ear n=12
|
|---|---|---|
|
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
|
11 Ear
|
|
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
|
12 Ear
|
Adverse Events
Dornase Alfa (Pulmozyme®)
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Ofloxin
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Dornase Alfa (Pulmozyme®)
n=19 participants at risk
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.
|
Ofloxin
n=22 participants at risk
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.
|
|---|---|---|
|
Infections and infestations
Upper Respiratory Tract Infection/Viral Illness
|
26.3%
5/19 • 3 months
|
18.2%
4/22 • 3 months
|
|
Ear and labyrinth disorders
Otitis Media
|
10.5%
2/19 • 3 months
|
22.7%
5/22 • 3 months
|
|
Ear and labyrinth disorders
Change in Hearing
|
10.5%
2/19 • 3 months
|
9.1%
2/22 • 3 months
|
|
Injury, poisoning and procedural complications
Cheek Laceration
|
5.3%
1/19 • 3 months
|
0.00%
0/22 • 3 months
|
|
Respiratory, thoracic and mediastinal disorders
Allergies
|
5.3%
1/19 • 3 months
|
0.00%
0/22 • 3 months
|
Additional Information
Kenny H. Chan, MD
University of Colorado School of Medicine - Department of Pediatric Otolaryngology
Phone: 7207774776
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place