Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets
Trevi Therapeutics · NCT07671911
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 40+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 306
- US sites recruiting
- 22
- Study start
- June 29, 2026
- Record last updated
- October 13, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The primary purpose is to evaluate the safety and efficacy of NAL ER for the treatment of chronic cough in participants with Idiopathic Pulmonary Fibrosis (IPF).
Being studied: NAL ER; Placebo
Conditions: Idiopathic Pulmonary Fibrosis
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full 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.
- 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.
Recruiting US locations
Newportnativemd, Inc.
Newport Beach, CA 92663-3600
Palmtree Clinical Research
Palm Springs, CA 92262
Paradigm Clinical Research Centers, Inc. - Redding
Redding, CA 96001
Critical Care Pulmonary and Sleep Associates (Ccpsa) - West Clinic
Lakewood, CO 80228
Meris Clinical Research
Brandon, FL 33511
Clinical Research Specialists, Llc - Kissimmee
Kissimmee, FL 34746-4654
Pulmonary Specialists of The Palm Beaches
Loxahatchee Groves, FL 33470
Clinical Research and Associates, Inc.
Miami, FL 33126
Coastal Pulmonary & Critical Care, PLC
St. Petersburg, FL 33704-2733
Tulane Clinic
New Orleans, LA 70112
Hannibal Regional Hospital
Hannibal, MO 63401
Renown Regional Medical Center - Center For Advanced Medicine B
Reno, NV 89502
Montefiore Medical Center
The Bronx, NY 10467-2401
Clinical Research of Gastonia (CRG)
Gastonia, NC 28054
Southeastern Research Center
Winston-Salem, NC 27103
Clinical Research Associates of Central, PA, LLC
DuBois, PA 15801
Anmed Medical Center
Anderson, SC 29621
Horizon Clinical Research Group
Cypress, TX 77429
El Paso Pulmonary Association, PA
El Paso, TX 79902
Elevate Clinical Research
Houston, TX 77058
Intermountain MedicalL Center- PulmonaryY and Critical Care Research
Murray, UT 84107
Pulmonary Associates of Richmond Inc (Par) - West Broad Location
Richmond, VA 23230-1710
Study contacts (from the official record)
- Paula Buckley · (203) 304-2499 · Paula.Buckley@trevitherapeutics.com