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Could a painkiller stop the cough that Won't quit in lung fibrosis?

NCT ID NCT07671911

Symptom relief Sponsor: Trevi Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 15, 2026 · Updated 5 times

Summary

This study tests whether an extended-release form of nalbuphine, a pain medication, can safely reduce chronic coughing in people with idiopathic pulmonary fibrosis (IPF), a lung scarring disease. About 306 adults with IPF and a cough lasting at least 8 weeks will receive either the drug or a placebo for 26 weeks. The main goal is to see if the drug lowers the number of coughs per day.

What this could mean

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

Active substance
nalbuphine extended-release tablets
What this could lead to
If it works, this could provide a new treatment option to ease chronic coughing in people with idiopathic pulmonary fibrosis, improving their quality of life.
What could go wrong
This is a Phase 3 trial, but it's still experimental. The drug may not reduce cough significantly, and side effects like drowsiness or dizziness are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 306 people

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

Started

Jun 2026

Expected to finish

Jul 2028

An estimate. End dates often move.

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

40 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: * Diagnosis of IPF as determined by the Investigator based on American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) clinical practice guidelines. * Chronic cough for ≥8 weeks prior to Screening. * PGI-Severity Score ≥ 2 at Screening. * Forced vital capacity (FVC) ≥40 percent (%) of predicted at Screening. * Diffusing capacity for carbon monoxide (DLCO) ≥25% of predicted during Screening or within 12 weeks prior to Screening. * Participants who are currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) approved for IPF should be on a stable dose for at least 6 weeks prior to the Baseline Visit. Exclusion Criteria: * Clinical diagnosis or clinical suspicion of an upper or lower respiratory tract infection in the last 8 weeks prior to the Screening visit or during Screening. * Hospitalization for any respiratory illness (including acute exacerbation of IPF) within 2 months prior to Screening. Note: Other protocol-defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis

As listed by the trial registrant

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

Idiopathic pulmonary fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    19 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Anmed Medical Center

    RECRUITING

    Anderson, South Carolina, 29621, United States

  • Clinical Research Associates of Central, PA, LLC

    RECRUITING

    DuBois, Pennsylvania, 15801, United States

  • Clinical Research Specialists, Llc - Kissimmee

    RECRUITING

    Kissimmee, Florida, 34746-4654, United States

  • Clinical Research and Associates, Inc.

    RECRUITING

    Miami, Florida, 33126, United States

  • Clinical Research of Gastonia (CRG)

    RECRUITING

    Gastonia, North Carolina, 28054, United States

  • Coastal Pulmonary & Critical Care, PLC

    RECRUITING

    St. Petersburg, Florida, 33704-2733, United States

  • Critical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic

    RECRUITING

    Lakewood, Colorado, 80228, United States

  • El Paso Pulmonary Association, PA

    RECRUITING

    El Paso, Texas, 79902, United States

  • Elevate Clinical Research

    RECRUITING

    Houston, Texas, 77058, United States

  • Hannibal Regional Hospital

    RECRUITING

    Hannibal, Missouri, 63401, United States

  • Horizon Clinical Research Group

    RECRUITING

    Cypress, Texas, 77429, United States

  • Meris Clinical Research

    RECRUITING

    Brandon, Florida, 33511, United States

  • Newportnativemd, Inc.

    RECRUITING

    Newport Beach, California, 92663-3600, United States

  • Palmtree Clinical Research

    RECRUITING

    Palm Springs, California, 92262, United States

  • Paradigm Clinical Research Centers, Inc. - Redding

    RECRUITING

    Redding, California, 96001, United States

  • Pulmonary Associates of Richmond Inc (Par) - West Broad Location

    RECRUITING

    Richmond, Virginia, 23230-1710, United States

  • Pulmonary Specialists of The Palm Beaches

    RECRUITING

    Loxahatchee Groves, Florida, 33470, United States

  • Southeastern Research Center

    RECRUITING

    Winston-Salem, North Carolina, 27103, United States

  • Tulane Clinic

    RECRUITING

    New Orleans, Louisiana, 70112, United States

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