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Can a pill save hearing during CF lung treatment?

NCT ID NCT02819856

Disease control Sponsor: Sound Pharmaceuticals, Incorporated 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Updated 2 times

Summary

This study tests whether SPI-1005, a drug containing ebselen, can prevent hearing loss in people with cystic fibrosis who are receiving IV tobramycin for a lung infection. About 40 participants will receive either a placebo or one of three doses of SPI-1005 for 21 days. Researchers will measure hearing, lung function, and side effects to see if the drug is safe and effective.

What this could mean

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

Active substance
SPI-1005 (ebselen)
What this could lead to
If it works, this could point toward a way to protect hearing in cystic fibrosis patients who need strong antibiotics.
What could go wrong
This is a small, early-phase trial with only 40 participants, so results may not apply to everyone. The drug may not prevent hearing loss or could have side effects.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

35 people

The number who actually took part.

Started

Jul 2017

Finished

Apr 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * Cystic fibrosis patients about to receive IV tobramycin for acute pulmonary exacerbation. * Voluntarily consent to participate in the study. * Females of childbearing potential should be using and committed to continue using one of the following acceptable birth control methods: * Sexual abstinence (inactivity) for 14 days prior to screening through study completion; or IUD in place for at least 3 months prior to study through study completion; or Barrier method (condom or diaphragm) with spermicide for at least 14 days prior to screening through study completion; or Stable hormonal contraceptive for at least 3 months prior to study through study completion. * Ability to perform all behavioral tests as indicated. Exclusion Criteria: * Current use or within 60 days prior to study enrollment the following IV ototoxic medications: aminoglycoside antibiotics (gentamicin, tobramycin, amikacin, streptomycin); platinum-containing chemotherapies (cisplatin, carboplatin, oxaliplatin); or loop diuretic (furosemide). * History of idiopathic sensorineural hearing loss, otosclerosis, or vestibular schwannoma. * History of middle ear or inner ear surgery. * Current conductive hearing loss or middle ear effusion. * Significant cardiovascular, hepatic, renal, hematologic, endocrine, immunologic, or psychiatric disease. * History of hypersensitivity or idiosyncratic reaction to compounds related to ebselen. * Participation in another investigational drug or device study within 30 days prior to study enrollment. * Female patients who are pregnant or breastfeeding.

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Conditions

The condition(s) this trial relates to.

cystic fibrosis hearing loss disorder Ototoxicity Tinnitus Vertigo toxic labyrinthitis prevention target

As listed by the trial registrant

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

Ototoxicity

Contacts and locations

Locations

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

More trials for these conditions

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