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OCEAN-2: NAL ER for chronic cough in idiopathic pulmonary fibrosis
NCT07868419Phase 3
Key facts
- Status
- Recruiting
- Start
- Sep 2026
- Primary completion
- Aug 2027
- Countries
- 1
- Sponsor
- Trevi Therapeutics
- Drugs
- nalbuphine
- Conditions
- chronic cough
01
Overview
Phase 3, randomised, double-blind trial of nalbuphine in chronic cough (2 arms), sponsored by Trevi Therapeutics. Primary endpoint: Relative Change from Baseline in 24-hour Cough Frequency at 14 weeks. Started Sep 2026; status: recruiting.
02
Design
2 arms- Study design
- RandomizedDouble-blind
NAL ER 54 mg
Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving NAL ER 54 mg twice daily (BID) for 12 weeks.
Placebo
Participants will undergo a 2-week blinded titration period followed by a fixed dose treatment period receiving a matching placebo BID for 12 weeks.
03
Who it enrols
Patients with Idiopathic Pulmonary Fibrosis and chronic cough for at least 8 weeks, with FVC >=40% and DLCO >=25% predicted, without recent respiratory infections or hospitalizations.
04
Endpoints
Primary
Relative Change from Baseline in 24-hour Cough Frequency
Secondary
Absolute Change from Baseline in the Cough Severity Numerical Rating Scale
Relative Change from Baseline in 24-hour Cough Frequency
Absolute Change from Baseline in 24-hour Cough Frequency
Proportion of Participants Achieving >=30%, >=50% and >=75% Reduction from Baseline in 24-hour Cough Frequency
Absolute Change from Baseline in the Evaluating Respiratory Symptoms in Idiopathic Pulmonary Fibrosis Cough Domain
Absolute Change from Baseline in the E-RS:IPF Total Score and Domain Scores
Absolute Change from Baseline in the CS-NRS
Proportion of Participants Achieving a >=3-point Improvement from Baseline in CS-NRS
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