Actively Enrolling - Clinical Trial for Patients with IPF-Related Chronic Cough
The OCEAN-1 trial is a Phase 3 clinical trial seeking to understand an investigational treatment, oral nalbuphine ER (extended-release) (NAL ER), and its potential effects on chronic cough in patients with idiopathic pulmonary fibrosis (IPF).
The OCEAN-1 Trial
Who Can Join
Adults aged 40 and older with a diagnosis of IPF and a persistent cough lasting at least 8 weeks.
What to Expect
Participation in this trial will take approximately one year and include taking an oral study drug (NAL ER or placebo).
Where it is Taking Place
United States, Canada, Spain, Poland, and the United Kingdom.
There is no cost to participate. You will be reimbursed for your time and trial-related expenses such as transportation costs and meals. In the OCEAN-1 trial, you will receive trial-related medical care from a dedicated team of healthcare providers.
Is the OCEAN-1 Trial Right for You?
To be able to take part in the OCEAN-1 trial, you must meet the following criteria:
- Adults aged 40 and older
- Have a diagnosis of IPF
- Have had a persistent cough for at least 8 weeks
Please note that this list above does not include all of the criteria. If you are able to participate, all further trial procedures will take place at the trial site with the Trial Doctor/Trial Team. The Trial Doctor will tell you if you are able to participate in this trial.
Why is it Important to Participate in Clinical Trials?
Clinical trials can only take place when patients with a certain disease or condition choose to participate. Examples of reasons patients choose to join clinical trials include:
1. To play a more active role in their own health care
2. To gain deeper understanding about their disease
3. To help find new or better treatments
Why Join the OCEAN-1 Trial?
By participating in the OCEAN-1 trial, it will help researchers to expand on their understanding of the efficacy and safety of oral NAL ER in patients with IPF-related chronic cough
The Trial at a Glance
Enrollment in the trial for approximately one year.
See a healthcare provider about once a month during the treatment period.
Taking an oral study drug (NAL ER or placebo).
A dedicated team who will monitor you throughout the trial.
Comprehensive medical testing, periodically wearing a 24-hour cough monitor, and completing electronic questionnaires.
No cost to participate. You will be reimbursed for your time and trial-related expenses such as transportation costs and meals.
What to Expect During the Trial
The trial will take approximately one year and includes screening, treatment, and follow‑up. During the treatment period, you will see a healthcare provider about once a month for medical testing. You will also be asked to periodically wear a 24-hour cough monitor and complete electronic questionnaires on a tablet provided by the study team.
Part 1
Screening
The trial team will check to see if you are a good fit for the trial.
Up to 4 Weeks
Part 2
Treatment
If you qualify and choose to continue, you will begin taking the study drug (either oral NAL ER or placebo). You will take two tablets each day, one in the morning and one in the evening.
- Weeks 1–2: Your dose will gradually increase to help your body adjust.
- Weeks 3-54: You will stay on a steady dose for the rest of the trial
54 Weeks
Part 3
Follow-up
Once you have completed treatment, the trial team will follow up with you periodically by phone with additional questions.
3 Weeks
What is a placebo and why is it used?
The purpose of a placebo is to show if the investigational treatment is working. The placebo looks identical to the investigational treatment but contains no active ingredients.
Patients will be randomly assigned to one of two treatment groups:
- oral NAL ER 54 mg twice a day
- oral placebo twice a day
Two out of every three participants will receive oral NAL ER.
This trial is double-blinded which means both the participant and clinical trial staff do not know which treatment group they are in.
Find an OCEAN-1 Trial Location Near You
Click on a marker to find a trial location near you. Use the contact details to call or email your closest trial location.
If you are not located near a trial location but are willing to travel, trial staff will provide reimbursement for travel expenses.
If you do contact the trial team, you do not have to join the OCEAN-1 trial.
Trial Locations
Thank you for considering participation in the OCEAN-1 trial for the treatment of patients with IPF-related chronic cough.
More information about this clinical trial can be found on ClinicalTrials.gov/study/NCT07671911
Doctor Referral Card
Interested in discussing this trial with your doctor? Use the following button to access the Doctor Referral Card. Take a picture or print out the card to bring with you when you speak to your doctor about the OCEAN-1 trial.
Frequently Asked Questions
What is a clinical trial?
A clinical trial is medical research aimed at understanding if investigational treatments work and if they are safe. All investigational treatments must undergo testing and obtain regulatory approval or authorization before they can be prescribed. Strict regulations ensure ethical treatment of participants. Trials are conducted by a team of healthcare professionals, typically funded by pharmaceutical companies.
Is there cost to participate?
Your participation is valuable. There is no cost to participate. You will be reimbursed for your time and trial-related expenses such as transportation costs and meals.
What oversight goes into clinical trials?
Before human studies are conducted sponsors must submit a trial plan and safety documentation to local health authorities and ethics committees, who must review it before the trial can start.
What is nalbuphine ER and how does it work?
NAL ER is an oral medication being studied for the treatment of chronic cough. NAL ER may help decrease the number of times a person coughs by working in the lungs and central nervous system. NAL ER was previously studied in two Phase 2 clinical trials in patients with IPF-related chronic cough.
Can I keep taking my antifibrotic medication when on NAL ER?
Yes, most antifibrotic medications, such as nintedanib and pirfenidone, may be continued during the OCEAN-1 trial.
Are there any potential risks if I join the OCEAN-1 trial?
Your safety is a priority. Your trial team will explain all the potential benefits and risks involved with participation in the trial, and you will have the chance to consider this carefully before deciding whether or not to participate.
Who do I contact if I have additional questions?
For additional questions, please contact the trial site closest to you using the trial finder in the “Find an OCEAN-1 Trial Location Near You” section. If you do contact the trial team, you do not have to join the OCEAN-1 trial.