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Reducing cough in patients with idiopathic pulmonary fibrosis using nalbuphine ER

A Randomized, Double-Blind, Placebo-Controlled, Parallel, 4-Arm Dose Ranging Study of the Safety and Efficacy of Nalbuphine Extended-Release Tablets (NAL ER) for the Treatment of Cough in Idiopathic Pulmonary Fibrosis (IPF)

Phase 2 Interventional Trevi Therapeutics · NCT05964335

This study is testing if a new medication called nalbuphine ER can help reduce coughing in people with idiopathic pulmonary fibrosis.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment160 (estimated)
Ages18 Years and up
SexAll
SponsorTrevi Therapeutics Industry-sponsored
Locations59 sites (Box Hill and 58 other locations)
Trial IDNCT05964335 on ClinicalTrials.gov

What this trial studies

This clinical trial is a multi-center, randomized, double-blind, placebo-controlled study designed to evaluate the efficacy of nalbuphine ER in reducing cough in patients diagnosed with idiopathic pulmonary fibrosis (IPF). Participants will be randomly assigned to one of four treatment arms, including varying doses of nalbuphine ER and a placebo, over a total duration of six weeks. The study will include a two-week titration period followed by a four-week fixed dose period, with assessments of cough severity and lung function throughout. The trial aims to provide insights into the potential benefits of nalbuphine ER for managing chronic cough associated with IPF.

Who should consider this trial

Good fit: Ideal candidates for this study are adults diagnosed with idiopathic pulmonary fibrosis who experience a chronic cough with a severity score of 4 or higher.

Not a fit: Patients currently on continuous oxygen therapy for longer than 16 hours may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients suffering from chronic cough due to idiopathic pulmonary fibrosis.

How similar studies have performed: Other studies have explored the use of nalbuphine for cough management, but this specific approach in IPF is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 subject's ability to successfully complete the study.
* Pregnant or lactating female subject.
* 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.

Where this trial is running

Box Hill and 58 other locations

+9 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary FibrosisCoughNalbuphine
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.