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

NCT ID NCT05964335

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 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 an extended-release form of nalbuphine, a pain medication, can reduce chronic coughing in people with idiopathic pulmonary fibrosis (IPF). 165 participants received either different doses of the drug or a placebo for 6 weeks. The main goal was to see if the drug lowered cough frequency measured by a digital monitor, and to check for side effects.

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 successful, this could provide a new treatment option to reduce chronic coughing in people with idiopathic pulmonary fibrosis, improving their quality of life.
What could go wrong
This is an early Phase 2 study with only 165 participants, so results may not confirm effectiveness or safety. The drug may cause side effects like drowsiness or nausea, and it may not work for everyone.

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

165 people

The number who actually took part.

Started

Feb 2024

Finished

Apr 2025

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: * Diagnosis of IPF as determined by the Principal Investigator based on ATS/ERS/JRS/ALAT guidelines. * Cough Severity Score ≥ 4 on CS-NRS (Cough Severity Numerical Rating Scale) during the Screening period and Baseline. * History of chronic cough for at least 8 weeks before screening. * SpO2 ≥ 92%, taken after at least 5 minutes in a sitting position, undisturbed and non-stimulated (Saturation of Hemoglobin with Oxygen as Measured by Pulse Oximetry). * FVC ≥ 40% predicted of normal - Forced Vital Capacity, as determined by spirometry adhering to ATS/ERS guidelines. * DLCO ≥ 25% predicted of normal - Diffusing capacity of the lung for carbon monoxide corrected for hemoglobin, assessed within the last 12 weeks, or at the time of screening. Exclusion Criteria: * Currently on continuous oxygen therapy for longer than 16 hours at any level or delivered by any modality. Intermittent oxygen use of any duration over any given 24-hour period is allowed. * Inadequate swallow reflex as assessed by the ability to sip 3 fluid oz (or 89 mL) of water without coughing or choking. * Upper or lower respiratory tract infection in the last 8 weeks prior to the baseline visit. * Clinical history of aspiration pneumonitis. * Diagnosis of sleep apnea. * Abnormal kidney or liver functions based on Screening lab results. * Known hypersensitivity to nalbuphine or to NAL ER excipients * History of major psychiatric disorder. * History of substance abuse. * Significant medical condition or other factors that may interfere with the participant's ability to successfully complete the study. * Pregnant or lactating female participant. * Known intolerance (gastrointestinal, central nervous system symptoms), hypersensitivity, drug allergy following the use of an opioid drug. * Use of opiates is prohibited within 14 days prior to the baseline visit. * Use of benzodiazepines are prohibited within 14 days prior to the baseline visit and for the duration of the study. * Monoamine oxidase inhibitors (MAOIs) including methylene blue (methylthioninium chloride) and the antibiotic linezolid are prohibited within 14 days prior to the baseline visit and for the duration of the study. * Use of oral corticosteroid cough treatment is prohibited within 4 weeks prior to the baseline visit and for the duration of the study. * Exposure to any investigational medication, including placebo, is prohibited within 4 weeks prior to the baseline visit and for the duration of the study. * Medications prescribed as cough suppressants are prohibited unless on a stable dose 14-days prior to the baseline visit and are expected to remain on that dose for the duration of the study. * Use of medications that affect serotonergic neurotransmission and that when used concomitantly with opioids can increase the risk of serotonin syndrome are prohibited unless on a stable dose 14-days prior to the baseline visit and are expected to remain on that dose for the duration of the study. * Anti-fibrotic medications are prohibited unless on a stable dose for 8 weeks prior to the baseline visit and are expected to remain on that dose for the duration of the study. * Strong inhibitors/inducers of the P450 Isozymes are prohibited unless on a stable dose for 14-days prior to baseline visit and are expected to remain on that dose for the duration of the study. * Use of a medication having a "known risk" of Torsade de Pointes (categorized as "KR" on the Credible Meds® website.) 4 weeks prior to Baseline. * Use of unstable doses of medications associated with a potential risk of QT prolongation but not clearly associated with Torsade de Pointes within 4 weeks of screening. Other protocol defined inclusion/exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

Cough idiopathic pulmonary fibrosis

As listed by the trial registrant

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

Idiopathic pulmonary fibrosis

Contacts and locations

Locations

  • Akdeniz University Faculty of Medicine

    Antalya, 7070, Turkey (Türkiye)

  • Altnagelvin Area Hospital

    Londonderry, BT47 6SB, United Kingdom

  • Austin Hospital

    Heidelberg, 3084, Australia

  • Azienda Ospedaliera San Gerardo di Monza

    Monza, 20900, Italy

  • Azienda Ospedaliera di Padova

    Padua, 35128, Italy

  • Azienda Ospedaliero - Universitaria Policlinico - Vittorio Emanuele- Ospedale Gaspare Rodolico

    Catania, 95123, Italy

  • Azienda Ospedaliero Universitaria Ospedali Riuniti Di Foggia

    Foggia, 71122, Italy

  • CIC Mauricie Inc.

    Trois-Rivières, Quebec, G8T 7A1, Canada

  • Canakkale Onsekiz Mart Universitesi (COMU) - Tip Fakultesi Hastanesi

    Çanakkale, 17020, Turkey (Türkiye)

  • Centre for Lung Health Clinic

    Vancouver, V5Z 1M9, Canada

  • Centro Respiratorio Integral Ltda

    Quillota, 2260877, Chile

  • Centro de Investigacion del Maule

    Talca, 3467384, Chile

  • Centro de Investigaciones de Enfermedades Respiratorias e Immunologic Limitada

    Villa Del Mar, 2520598, Chile

  • Churchill Hospital

    Oxford, OX3 7LE, United Kingdom

  • Clinica Mi Tres Torres Barcelona

    Barcelona, 08017, Spain

  • Clinica Universidad de los Andes

    Santiago, 7620157, Chile

  • Concord Repatriation General Hospital

    Concord, 2139, Australia

  • Dynamic Drug Advancement

    Ajax, L1S 2J5, Canada

  • Eastern Health-Box Hill Hospital

    Box Hill, 3128, Australia

  • Ege University Medical Faculty

    Izmir, 35100, Turkey (Türkiye)

  • Erasmus Medisch Centrum 1

    Rotterdam, 3015 GD, Netherlands

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Rome, 00168, Italy

  • Gulhane Askeri Tip Akademisi (GATA) - Gulhane Askeri Tip Fakultesi (Gulhane Military Medical Academy and Medical School)

    Ankara, 06010, Turkey (Türkiye)

  • HMC (Haaglanden Medisch Centrum) Bronovo

    The Hague, 2512 VA, Netherlands

  • HUMV

    Santander, 39008, Spain

  • Hospital Carlos Van Buren

    Valparaíso, 2352499, Chile

  • Hospital Clinico Regional Dr. Guillermo Grant Benavente

    Concepción, 4040324, Chile

  • Hospital La Milagrosa

    Madrid, 28010, Spain

  • Hospital Universitari de Bellvitge

    Barcelona, 08907, Spain

  • Hull and East Yorkshire - Castle Hill Hospital

    Cottingham, HU16 5JQ, United Kingdom

  • IKF Institut fuer klinische Forschung Frankfurt

    Frankfurt am Main, 60596, Germany

  • IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz

    Mainz, 55128, Germany

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ, Netherlands

  • Krankenhaus Bethanien

    Solingen, 42699, Germany

  • Martini Ziekenhuis

    Groningen, 9728 NT, Netherlands

  • Medizinische Hochschule Hannover, Hannover Medical School

    Hanover, 30625, Germany

  • Norfolk and Norwich University Hospital

    Norwich, NR4 7UY, United Kingdom

  • Nottingham City Hospital

    Nottingham, NG5 1PB, United Kingdom

  • Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2GW, United Kingdom

  • Respiratory Clinical Trials Pty Ltd

    Kent Town, 5067, Australia

  • Royal Brompton Hospital

    London, SW3 6NP, United Kingdom

  • Royal Infirmary Of Edinburgh

    Edinburgh, EH16 4SA, United Kingdom

  • Royal Papworth Hospital

    Cambridge, CB2 0AY, United Kingdom

  • Samodzielny Publiczny Wojewodzki Szpital Zespolony w Szczecinie

    Szczecin, 70-891, Poland

  • Selcuk Universty Medical Faculty

    Konya, 42130, Turkey (Türkiye)

  • Southampton General Hospital

    Southampton, SO16 6YD, United Kingdom

  • Southern Health & Social Care Trust, Craigavon Area Hospital

    Portadown, BT63 5QQ, United Kingdom

  • Sureyyapasa Gogus Hastaliklari ve Gogus Cerrahisi Egitim ve Arastirma Hastanesi

    Istanbul, 34854, Turkey (Türkiye)

  • The Pacific Lung Health Centre - St. Pauls Hospital

    Vancouver, V6Z 1Y6, Canada

  • TrialsWest Pty Ltd

    Spearwood, 6163, Australia

  • Universitatsklinik Ruhrlandklinik, Westdeutsches Lungenzentrum

    Essen, 45239, Germany

  • University College London

    London, NW1 2PG, United Kingdom

  • University Hospital of Leipzig

    Leipzig, 04103, Germany

  • University Medical Center of Johannes Gutenberg-University Mainz

    Mainz, 55131, Germany

  • Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego

    Lodz, 90-153, Poland

  • Uniwersyteckie Centrum Kliniczne (UCK)

    Gdansk, 80-214, Poland

  • Warminsko Mazurskie Centrum Chorob Pluc w Olsztynie

    Olsztyn, 10-357, Poland

  • Westmead Hospital

    Westmead, 2145, Australia

  • Wythenshawe Hospital

    Manchester, M23 9LT, United Kingdom

More trials for these conditions

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