About the study
OCEAN-2 is a Phase 3 study testing whether nalbuphine extended-release (NAL ER) tablets, an investigational oral treatment, reduce chronic cough in people with idiopathic pulmonary fibrosis (IPF). Participants are assigned by chance to take either NAL ER or a placebo (a tablet with no active medicine) for about 12 weeks. Cough is measured over 24 hours with a small recording device, along with questionnaires about how cough affects daily life.
Who can participate
You may be eligible if you:
- Are 40 years of age or older
- Have been diagnosed with idiopathic pulmonary fibrosis (IPF)
- Have had a cough for at least 8 weeks
- If you take an antifibrotic medicine (such as nintedanib or pirfenidone), have been on a stable dose for at least 6 weeks
Other criteria apply. A research coordinator will review eligibility with you, and a study doctor confirms it at a screening visit.
What to expect
- A screening visit with breathing tests and an eligibility review
- About 12 weeks of study tablets, with follow-up to about week 17
- 24-hour cough recordings at home using a small portable device
- Regular check-ins on your health and any side effects
Learn more
The full study record, including all eligibility criteria and outcome measures, is on ClinicalTrials.gov (NCT07868419).