Nalbuphine Extended-Release Tablets to Reduce IPF-Related Chronic Cough

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind study compares nalbuphine extended-release tablets to placebo in adults with IPF and persistent cough. Eligible participants have documented IPF, a chronic cough for at least 8 weeks, and specific lung function criteria, and must be on a stable antifibrotic regimen if applicable. The trial aims to assess safety and efficacy over a defined treatment period. Sites are located in California, with Trevi Therapeutics as the lead sponsor. Exclusion criteria include recent respiratory infections or hospitalization for respiratory illness.

Why it matters

Who can join: the full rules

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.

Where it's running

• Newportnativemd, Inc.
  Newport Beach, California, United States Recruiting
• Palmtree Clinical Research
  Palm Springs, California, United States Recruiting
• Paradigm Clinical Research Centers, Inc. - Redding
  Redding, California, United States Recruiting
• Critical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic
  Lakewood, Colorado, United States Recruiting
• Meris Clinical Research
  Brandon, Florida, United States Recruiting
• Clinical Research Specialists, Llc - Kissimmee
  Kissimmee, Florida, 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.

• 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.

  Recruiting at 2 sites Phase 2 Oorja Bio, Inc. · Doral, Florida and 1 other locations · NCT07869147

• Nalbuphine ER for IPF-related chronic cough

  This study tests whether extended-release nalbuphine tablets can reduce chronic cough in people with idiopathic pulmonary fibrosis.

  Recruiting at 4 sites Phase 3 Trevi Therapeutics · Wilmington, Delaware and 3 other locations · NCT07868419

• 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.

  Recruiting Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07820254

• 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.

  Recruiting Istituto Clinico Humanitas · Rozzano, Italy · NCT07790614

• 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.

  Recruiting at 12 sites Phase 3 InSilico Medicine Hong Kong Limited · Hefei, Anhui and 46 other locations · NCT07687459

• Inhaled nintedanib powder for IPF in adults

  This study tests whether an inhaled form of nintedanib can safely help adults with idiopathic pulmonary fibrosis.

  Recruiting Phase 2 Mannkind Corporation · Windsor, Ontario · NCT07679893

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.