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Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough Reduction With Nalbuphine Extended-Release (NAL ER) Tablets

NCT07671911

RecruitingPhase 3

Sponsor: Trevi Therapeutics

Conditions: Idiopathic Pulmonary Fibrosis

Interventions: NAL ER, Placebo

Countries: United States

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).

Eligibility overview

Sex: ALL

Age: 40 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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 (e.g., 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 2 months prior to Screening.
* Diagnosed sleep apnea or currently on any treatment for sleep apnea \[example (e.g.), Continuous Positive Airway Pressure (CPAP)\].

Note: Other protocol-defined inclusion/exclusion criteria may apply.

Locations (5)

Loxahatchee Groves, Florida, United States
Miami, Florida, United States
Gastonia, North Carolina, United States
El Paso, Texas, United States
Houston, Texas, United States