Nalbuphine extended-release tablets for chronic cough in idiopathic pulmonary fibrosis
Tests nalbuphine extended-release tablets against placebo for chronic cough in people with idiopathic pulmonary fibrosis.
Plain-language title generated from the registry record
Registry title: Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine (NAL) Extended-Release (ER) Tablets
Key facts
- Where
- Charlotte, North Miami Beach, Sugar Land, and Wilmington, United StatesSee the 4 sites
- Phase
- Phase 3
Where in United States
- American Health Research - Charlotte LocationCharlotte, United StatesTaking people
- Essential Health and Research ServicesNorth Miami Beach, United StatesTaking people
- Hillcroft Medical ClinicSugar Land, United StatesTaking people
- Premier Medical Associates, LLCWilmington, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Trevi Therapeutics
- Trial code
- NCT07868419
- Record updated
- 9 October 2026
- Original description
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.Read full original descriptionShow less
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
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with IPF.
Inclusion: 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: 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.