Treatment of Clogged Tympanostomy Tubes: An Off-Label Use of Dornase Alfa (Pulmozyme®)

NCT ID: NCT00419380

Last Updated: 2015-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-01-31
• Study Completion Date: 2011-05-31

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.

Conditions

Otitis Media

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

dornase alfa (Pulmozyme®)

dornase alfa - Pulmozyme®: 5 drops twice daily for 7 days to the affected ear.

Group Type: ACTIVE_COMPARATOR

dornase alfa (Pulmozyme®)

Intervention Type: 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.

Ofloxin

Ofloxin : 5 drops twice daily for 7 days to the affected ear.

Group Type: ACTIVE_COMPARATOR

dornase alfa (Pulmozyme®)

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Colorado, Denver

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kenny H Chan, MD

Role: PRINCIPAL_INVESTIGATOR

The Children's Hospital

Locations

The Children's Hospital

Denver, Colorado, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 30073253 (View on PubMed)

Other Identifiers

BB-IND Number: 100242

Identifier Type: -

Identifier Source: secondary_id

06-0556

Identifier Type: -

Identifier Source: org_study_id