Nalbuphine ER for IPF-related chronic cough
Official title: A Randomized, Double-Blind, Placebo-Controlled Twelve-Week Fixed-Dose Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis
Run by Trevi Therapeutics · NCT07868419 · Data updated 2026-11-12
This study tests whether extended-release nalbuphine tablets can reduce chronic cough in people with idiopathic pulmonary fibrosis.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 40 Years and up |
| Sex | All |
| Enrollment | 201 (estimated) |
| Sponsor | Trevi Therapeutics Industry-sponsored |
| Locations | 4 sites (Wilmington, Delaware and 3 other locations) |
| Status | Recruiting |
| Started | September 30, 2026 |
| Main results expected | August 2027 |
| Study ends | October 2027 |
| Registry record updated | October 9, 2026 |
| Trial ID | NCT07868419 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with IPF, chronic cough of at least 8 weeks, and preserved lung function who are on a stable antifibrotic regimen if applicable.
✕Probably not a fit
Individuals without significant cough reduction or with certain comorbidities may not experience a benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 trial compares nalbuphine extended-release tablets to placebo in adults with IPF and chronic cough. Participants must have IPF diagnosed by guidelines, persistent cough for at least 8 weeks, and adequate lung function measures. The study excludes recent respiratory infections and recent IPF hospitalizations. Locations include sites in Delaware, Florida, and North Carolina, with Trevi Therapeutics as the lead sponsor.
Why it matters
Potential benefit: If successful, participants may experience a reduction in IPF-related cough and an improvement in quality of life.
How similar studies have gone: Prior studies in related cough therapies have shown mixed results; this trial tests a novel analgesic approach specifically for IPF-related cough.
Who can join: the full rules
Show full inclusion / exclusion criteria
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. * If currently taking antifibrotic medication (nintedanib, pirfenidone, nerandomilast) 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 8 weeks prior to Screening. Note: Other protocol-defined inclusion/exclusion criteria may apply.
Where it's running
-
Premier Medical Associates, LLC
Wilmington, Delaware, United States Recruiting -
Essential Health and Research Services
North Miami Beach, Florida, United States Recruiting -
American Health Research - Charlotte Location
Charlotte, North Carolina, United States Recruiting -
Hillcroft Medical Clinic
Sugar Land, Texas, United States Recruiting
Study contacts
- Study coordinator: Paula Buckley
- Email: Paula.Buckley@trevitherapeutics.com
- Phone: (203) 304-2499
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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New IPF drug ORJ-001 tested in adults with IPF
A phase 2 study tests ORJ-001 versus placebo in adults with idiopathic pulmonary fibrosis to see if it is tolerated and whether it helps lung function.
-
Inspiratory Flow Rate Capability in Pulmonary Fibrosis Patients
This observational study tests how fast patients with IPF or PPF can inhale through dry powder inhalers with different resistances.
-
Photon-counting CT vs standard HRCT to help diagnose IPF and other ILDs
This study tests whether photon-counting CT can improve identifying IPF and other ILDs compared with standard HRCT for patients discussed in multidisciplinary teams.
-
Rentosertib by mouth for people with idiopathic pulmonary fibrosis
This is a randomized, placebo-controlled test to see if Rentosertib helps adults with idiopathic pulmonary fibrosis when taken as a pill.
-
Inhaled nintedanib powder for IPF in adults
This study tests whether an inhaled form of nintedanib can safely help adults with idiopathic pulmonary fibrosis.
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Nalbuphine Extended-Release Tablets to Reduce IPF-Related Chronic Cough
A Phase 3 trial tests whether nalbuphine extended-release tablets can lessen chronic cough in adults with idiopathic pulmonary fibrosis compared with a placebo.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.