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NAL ER for Idiopathic Pulmonary Fibrosis (IPF)-Related Chronic Cough

This study is looking into whether NAL ER tablets can help reduce chronic cough in people with Idiopathic Pulmonary Fibrosis (IPF). IPF is a lung disease that causes scarring of the lungs. Researchers want to see if NAL ER is safe and effective for this type of cough. You might be able to join if you are 40 years or older, have been diagnosed with IPF by a doctor, and have had a chronic cough for at least 8 weeks. The main goal is to see how much your 24-hour cough frequency changes after 26 weeks of treatment. The study is currently unclear on its recruitment status and plans to enroll about 306 participants.

Study design
This interventional study will compare NAL ER oral tablets to a placebo (an inactive pill) in about 306 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your cough frequency will be measured at the beginning of the study and again at Week 26.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07671911

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

Recruiting
PHASE3Ages 40+InterventionalTreatment
Trevi Therapeutics
~306 participants
Updated 2026-07-10 on ClinicalTrials.gov
What's tested:NAL ERPlacebo

At a glance

Recruiting sites
5 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Relative Change from Baseline in 24-hour Cough Frequency at Week 26
Measured over Baseline, Week 26

Conditions

Idiopathic Pulmonary Fibrosis

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Idiopathic Pulmonary Fibrosis

Where it's being run

5 sites across 3 states
Florida2
Texas2
North Carolina1

Study leadership

  • Chief Development Officer · STUDY_DIRECTOR · Trevi Therapeutics

Who to contact

Paula Buckley
[email protected]
(203) 304-2499
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

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.
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

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 \[example (e.g.), Continuous Positive Airway Pressure (CPAP)\].

What this trial measures

  • Relative Change from Baseline in 24-hour Cough Frequency at Week 26Baseline, Week 26