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| ID | Type | Description | Link |
|---|---|---|---|
| BB-IND Number: 100242 |
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| Name | Class |
|---|---|
| Genentech, Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dornase alfa (Pulmozyme®) | Active Comparator | dornase alfa - Pulmozyme®: 5 drops twice daily for 7 days to the affected ear. |
|
| Ofloxin | Active Comparator | Ofloxin : 5 drops twice daily for 7 days to the affected ear. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dornase alfa (Pulmozyme®) | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patency of the Tympanostomy Tube at the Day-14 Visit. | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 14 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kenny H Chan, MD | The Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Children's Hospital | Denver | Colorado | 80218 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30073253 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patency of the Tympanostomy Tube at the Day-14 Visit. | Analysis performed on ear level. Some participants received drops in both ears and thus both ears were included in analysis. | Posted | Number | Ear | 14 days |
|
3 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Upper Respiratory Tract Infection/Viral Illness | Infections and infestations | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kenny H. Chan, MD | University of Colorado School of Medicine - Department of Pediatric Otolaryngology | 7207774776 | kenny.chan@childrenscolorado.org |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| ID | Term |
|---|---|
| D010031 | Otitis |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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| ID | Term |
|---|---|
| C568813 | dornase alfa |
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| Lost to Follow-up |
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| Withdrawal by Subject |
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| 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units |
|---|
| Counts |
|---|
| Participants |
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| 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 | Posted | Number | Ear | 14 days |
|
|
|
|
| 0 |
| 19 |
| 11 |
| 19 |
| EG001 | 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. | 0 | 22 | 11 | 22 |
| Otitis Media | Ear and labyrinth disorders | Non-systematic Assessment |
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| Change in Hearing | Ear and labyrinth disorders | Non-systematic Assessment |
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| Cheek Laceration | Injury, poisoning and procedural complications | Non-systematic Assessment |
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| Allergies | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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