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Could a cystic fibrosis drug unclog Kids' ear tubes?

NCT ID NCT00419380

Disease control Sponsor: University of Colorado, Denver Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested whether dornase alfa (Pulmozyme) ear drops can unclog tympanostomy tubes in children better than standard ofloxacin drops. 41 children aged 1 to 18 with clogged tubes received either treatment for 7 days. The main goal was to see if the tube was open at day 14.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
dornase alfa (Pulmozyme) ear drops
What this could lead to
If it works, this could offer a new way to unclog ear tubes in children, potentially avoiding the need for tube replacement surgery.
What could go wrong
This is a small, completed phase 4 trial with only 41 participants. The drug is used off-label, and it may not work better than standard ear drops. Risks include ear irritation or lack of improvement.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

41 people

The number who actually took part.

Start date

Jan 2007

Finished

May 2011

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

1 year to 18 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

otitis media

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Otitis media

Contacts and locations

Locations

  • The Children's Hospital

    Denver, Colorado, 80218, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.