NCT00419380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

January 4, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 8, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

March 27, 2015

Completed
Last Updated

June 8, 2026

Status Verified

May 1, 2026

Enrollment Period

4.3 years

First QC Date

January 4, 2007

Results QC Date

February 24, 2015

Last Update Submit

May 13, 2026

Conditions

Otitis Media

Keywords

clogged ear tubes

Outcome Measures

Primary Outcomes (1)

  • Patency of the Tympanostomy Tube at the Day-14 Visit.

    14 days

Secondary Outcomes (1)

  • Presence or Absence of Drainage in the Ear Canal and Fluid in the Middle Ear at the the Day-14 Visit.

    14 days

Study Arms (2)

dornase alfa (Pulmozyme®)

ACTIVE COMPARATOR

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

Drug: dornase alfa (Pulmozyme®)

Ofloxin

ACTIVE COMPARATOR

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

Drug: dornase alfa (Pulmozyme®)

Interventions

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.

Ofloxindornase alfa (Pulmozyme®)

Eligibility Criteria

Age1 Year - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital

Denver, Colorado, 80218, United States

Location

Related Publications (1)

  • 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.

    PMID: 30073253DERIVED

MeSH Terms

Conditions

Otitis Media

Interventions

dornase alfa

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

Title
Kenny H. Chan, MD
Organization
University of Colorado School of Medicine - Department of Pediatric Otolaryngology
kenny.chan@childrenscolorado.org
7207774776

Study Officials

  • Kenny H Chan, MD

    The Children's Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2007

First Posted

January 8, 2007

Study Start

January 1, 2007

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

June 8, 2026

Results First Posted

March 27, 2015

Record last verified: 2026-05

Locations

US(1)