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Efficacy and Safety of Nalbuphine ER for Reducing Chronic Cough in Adults with Idiopathic Pulmonary Fibrosis (OCEAN-1)

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study focuses on a lung condition called Idiopathic Pulmonary Fibrosis, which causes scar tissue to form in the lungs and makes breathing difficult. A common problem for people with this condition is a long‑lasting Chronic Cough, meaning a cough that persists for months. The medication being tested is an extended‑release tablet taken by mouth, known as Nalbuphine ER. Two dose strengths of the tablet (108 mg and 54 mg) are being evaluated.

The purpose of the study is to see whether the medication can reduce how often a person coughs over a 24‑hour period. Participants will be randomly assigned to receive either the study drug or a placebo, and neither the participants nor the study staff will know which is being taken. Over about six months, participants will take the tablets each day and attend regular visits where a small device will be used to count coughs for a full day and questionnaires will assess how severe the cough feels. Safety checks and basic health assessments will be done throughout the study.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Randomization and Receipt of Study Medication

    After enrollment, you will be randomly assigned to receive either the active drug nalbuphine ER or a matching placebo. The assignment is kept secret from both you and the study staff (double‑blind design).

    If you are assigned to the active group, you will receive oral film‑coated tablets containing either 108 mg or 54 mg of nalbuphine hydrochloride. If you are assigned to the placebo group, you will receive tablets that look identical but contain no active drug.

  2. Step 2

    Baseline Assessments

    Before starting the medication, you will undergo a series of baseline measurements to evaluate your chronic cough.

    You will wear a 24‑hour cough monitor that records the number of coughs you produce each hour. This objective measurement will be used as a reference for later comparisons.

    You will also complete the Cough Severity Numeric Rating Scale (CS‑NRS), a questionnaire in which you rate how severe your cough feels.

  3. Step 3

    Start of Daily Medication

    Following the baseline assessments, you will begin taking the study tablets exactly as instructed by the study protocol.

    The tablets are taken by mouth (oral route) and are film‑coated for easy swallowing.

    You will continue this daily dosing for the entire duration of the trial, which lasts until the final assessment at week 26.

  4. Step 4

    Ongoing Daily Dosing and Symptom Monitoring

    Each day you will take the assigned tablet at the same time to maintain consistent drug levels.

    You should keep a simple diary noting any side effects or changes in your cough, although detailed medical evaluation will be performed only at scheduled study visits.

  5. Step 5

    Final Assessment at Week 26

    At the end of week 26, you will repeat the 24‑hour cough monitoring to determine how your cough frequency has changed compared with the baseline measurement.

    You will also complete the CS‑NRS again to assess any change in cough severity.

    These data will be used to calculate the relative change in cough frequency and the absolute change in CS‑NRS scores for the study’s primary and secondary objectives.

  6. Step 6

    End of Study and Discontinuation of Medication

    After the final assessments, you will stop taking the study medication.

    The study staff will provide any necessary instructions for post‑study follow‑up, but no further study‑specific procedures are required.

Who can join the trial?

4 criteria

  • You must sign a written informed consent and give permission for the study team to use your protected health information, which is your personal medical data.
  • You must be at least 40 years old at the time you sign the consent form.
  • You must have a diagnosis of IPF (idiopathic pulmonary fibrosis), a type of lung scarring, confirmed by the doctor using accepted medical guidelines (the ATS/ERS/JRS/ALAT clinical practice guidelines).
  • You must have had a chronic cough—a cough that continues for a long time—for at least 8 weeks before the screening visit.

Who cannot join the trial?

3 criteria

  • You have had a doctor‑diagnosed or suspected upper or lower respiratory tract infection (an infection of the nose, throat, lungs, or breathing tubes) in the last 8 weeks or during the screening visit.
  • You have been hospitalized (admitted to the hospital) for any breathing‑related illness, including a sudden worsening of idiopathic pulmonary fibrosis (IPF), in the last 8 weeks before screening.
  • You have been diagnosed with sleep apnea (a condition where breathing stops briefly while you sleep) or are currently using any treatment for it, such as a CPAP machine (a device that provides steady air pressure to keep the airway open).
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Investigated drugs

Nalbuphine ER is an extended‑release oral tablet that is being tested to see if it can reduce the number of coughs a person with idiopathic pulmonary fibrosis has over a 24‑hour period. In the study, participants take this medication regularly, and researchers measure how often they cough using a special monitoring device. The goal is to find out whether the medicine can safely and effectively lessen chronic cough in these patients.

What is already known about the treatment

Nalbuphine ER - This medication is taken by mouth as a film‑coated extended‑release tablet, available in 54 mg and 108 mg strengths. Nalbuphine is an established opioid drug that is approved in several countries for pain relief and is now being studied for chronic cough in patients with idiopathic pulmonary fibrosis. It works by activating kappa opioid receptors while blocking mu opioid receptors, which helps reduce the cough reflex without producing strong opioid effects. Pharmacologically, it is classified as a mixed opioid agonist‑antagonist.

Investigated diseases

Chronic cough - Chronic cough is a cough that lasts for at least eight weeks. It is a symptom rather than a disease and can be caused by irritation of the airways. The cough persists despite usual remedies and may fluctuate in intensity. Over time, the cough can become more frequent and may interfere with daily activities. It is often associated with underlying respiratory conditions but can also occur without an identifiable cause.
Trial detailsLast updated 31 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2026-525877-38-00Protocol codeNAL03-301Estimated enrolment306 patientsSponsorTrevi Therapeutics Inc.

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