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Can a drug combo heal breathing tube damage to the voice box?

NCT ID NCT03250975

Disease control Sponsor: Vanderbilt University Medical Center 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 30, 2026 · Updated 2 times

Summary

This study tracks how often people get voice box injuries after having a breathing tube for 1 to 7 days in the ICU. It also tests whether a 14-day course of budesonide and azithromycin can help heal those injuries and improve breathing. About 64 adults who had a breathing tube will take part.

What this could mean

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

Active substance
budesonide and azithromycin
What this could lead to
If it works, this could point toward a treatment to speed healing of voice box injuries from breathing tubes.
What could go wrong
This is a small, early-phase study with only 64 participants, so results may not apply widely. The drugs may not improve symptoms.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 64 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2017

Expected to finish

Dec 2026

An estimate. End dates often move.

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: 1. English-speaking 2. Greater than 24 hours and less than 7 days of intubation in the intensive care unit Exclusion Criteria: 1. Age under 18 years on admission 2. Patients with anticipated discharge 5 days after extubation 3. Patients who are dependent for activities of daily living (ADLs) in the 30 days prior to admission 4. Patients unable to consent 5. Patients with neck trauma 6. Patients with head and neck malignancies 7. Patients with pre-existing laryngeal or tracheal stenosis 8. Patients with other pre-existing respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, neuromuscular dystrophies, cystic fibrosis, bronchiectasis 9. Patients who had been previously intubated for an extended period of time 10. Patients who are pregnant or currently breastfeeding 11. Patients with allergies to study medications 12. Patients with a resting heart rate greater than 100 beats per minute 13. Patients with a prolonged corrected QT (QTc) interval (\>450 msec) or the use of medications that prolong the QTc interval or are associated with Torsades de pointes (with the exception of amiodarone)24 14. Patients with severe hearing impairment documented by audiometric testing

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Conditions

The condition(s) this trial relates to.

acute laryngitis

As listed by the trial registrant

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

Intubation complication

Contacts and locations

Locations

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

More trials for these conditions

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