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NCT Number: NCT07671911

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

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).

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Key information

Conditions

Idiopathic Pulmonary Fibrosis Lung Diseases Lung Diseases, Interstitial Pulmonary Fibrosis Respiratory Tract Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Pulmonary Specialists of The Palm Beaches, Loxahatchee Groves, Florida, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

NAL ER

Drug

Oral tablets

Other names: Nalbuphine

Placebo

Drug

Oral tablets

Primary outcomes

  1. Relative Change from Baseline in 24-hour Cough Frequency at Week 26

    Time frame: Baseline, Week 26

Secondary outcomes

  1. Absolute Change from Baseline in the Cough Severity Numerical Rating Scale (CS-NRS) at Week 26

    Time frame: Baseline, Week 26

  2. Relative Change from Baseline in 24-hour Cough Frequency at Week 6

    Time frame: Baseline, Week 6

  3. Percentage of Participants Achieving ≥50% Reduction from Baseline in 24-hour Cough Frequency at Week 26

    Time frame: Baseline, Week 26

  4. Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis (E:RS-IPF) Cough Domain at Week 26

    Time frame: Baseline, Week 26

  5. Percentage of Participants Achieving a ≥3-point Improvement from Baseline in CS-NRS at Week 26

    Time frame: Baseline, Week 26

  6. Absolute Change from Baseline in the E:RS IPF Breathlessness Domain at Week 26

    Time frame: Baseline, Week 26

  7. Relative Change from Baseline in 24-hour Cough Frequency

    Time frame: Baseline up to Week 54

  8. Percentage of Participants Achieving ≥30%, ≥50% and ≥75% Reduction from Baseline in 24-Hour Cough Frequency

    Time frame: Baseline up to Week 54

  9. Absolute Change from Baseline in the E-RS:IPF Cough Domain

    Time frame: Baseline up to Week 54

  10. Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores (IPF-Breathlessness, IPF-Cough, IPF-Sputum, and IPF-Chest Symptoms)

    Time frame: Baseline up to Week 54

  11. Absolute Change from Baseline in the CS-NRS

    Time frame: Baseline up to Week 54

  12. Percentage of Participants Achieving a ≥3-Point Improvement from Baseline in CS-NRS

    Time frame: Baseline up to Week 54

  13. Absolute Change from Baseline in the Leicester Cough Questionnaire (LCQ) Total Scores

    Time frame: Baseline up to Week 54

  14. Percentage of Participants Achieving a 1.3-Point Increase (Improvement) from Baseline in LCQ Total Score

    Time frame: Baseline up to Week 54

  15. Absolute Change from Baseline in Each LCQ Domain Score (Physical, Psychological, Social)

    Time frame: Baseline up to Week 54

  16. Change from Baseline in the European Quality of Life 5 Dimensions 5 Level (EQ-5D-5L) at Week 26

    Time frame: Baseline, Week 26

  17. Relative Change from Baseline in Awake Cough Frequency

    Time frame: Baseline up to Week 54

  18. Relative Change from Baseline in Sleep Cough Frequency

    Time frame: Baseline up to Week 54

  19. Absolute Change from Baseline in the Patient Global Impression of Severity (PGI-S) Cough Score

    Time frame: Baseline up to Week 54

  20. Absolute Change from Baseline in the Patient Global Impression of Change (PGI-C) Cough Score

    Time frame: Baseline up to Week 54

  21. Percentage of Participants with Improvements by ≥1 and ≥2 Categories from Baseline on the PGI-S Cough

    Time frame: Baseline up to Week 54

  22. Safety and Tolerability as Assessed by Number of Participants with Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to Week 57

Study contacts

Contact information is provided by the study sponsor or research team.

Paula Buckley

CONTACT

[email protected]

(203) 304-2499

Sponsors and collaborators

Lead sponsor

Trevi Therapeutics

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Nalbuphine Extended-Release Tablets for the Treatment of Chronic Cough in Participants With Idiopathic Pulmonary Fibrosis

Acronym: OCEAN-1

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jun 26, 2026
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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