CORAL: A clinical trial investigating a potential new drug for chronic cough in Idiopathic Pulmonary Fibrosis (IPF)

Upcoming study
Expected to open February 2024
This study is currently recruiting
Expected to close October 2024
This study is closed
This study closed in October 2024
We will update this page with study results when available.
Information on study results are included below
This study closed in October 2024
Ask your healthcare team about taking part in research

What next?

Original listing:

What next?

Original listing:

About this study

The CORAL study is understanding whether a drug called nalbuphine extended release (ER) could treat chronic cough in people with Idiopathic Pulmonary Fibrosis (IPF). The extended release means that the drug is slowly and consistently released over a period of time.

Cough is one of the most common symptoms for people with IPF and there are currently no approved treatments to help reduce it. Doctors sometimes prescribe medicines that may slow down the scarring process or medications to reduce the inflammation in the lungs. However, patients may not experience relief from coughing.

This drug has been tested in a small group of people.

The aim of this clinical trial is to confirm if similar results are found in a larger number of people with IPF. This will help researchers to understand how the drug works and whether different doses of the study drug, nalbuphine, may help to reduce cough for people with IPF.


What is involved?

You will be assigned to one of four groups in this trial:

  1. placebo tablets twice a day
  2. oral nalbuphine ER 27mg twice a day
  3. oral nalbuphine ER 54mg twice a day
  4. oral nalbuphine ER 108mg twice a day

Three out of every four people will receive the study drug, nalbuphine as a tablet. One out of every four people will receive placebo. A placebo is a tablet that looks the same as the drug, but does not contain any of the active ingredients. You will not know which tablet you have been given.

If you would like to join the study, you will be assessed to confirm if you are eligible to take part.  If you are able to take part, you will have 6 in-person study visits and 2 check-in phone calls. During the on-site visits, the study team will carry out various medical assessments and occasionally place a wearable cough monitor on you to use for a 24-hour period. Additionally, you will be asked to complete daily surveys on a digital tablet throughout the study.

Travel reimbursement will be made available to you.

Summary of involvement

6 weeks of taking nalbuphine ER tablets twice per day.

Medical assessments.

Wearing a 24-hour cough monitor four times throughout the study.

Completing surveys using an electronic diary.

Can I take part?

Approximately 160 people from around the world are expected to take part in this trial. To be able to take part, you must meet certain criteria. Please note that the list below is a summary, and  does not include all the reasons why you may or may not be able to take part. The study physician will inform you whether you are eligible to participate in this study.

In research studies, there are lots of different reasons why you may or may not be able to take part. These are known as inclusion and exclusion criteria (see list below). Only the research team will be able to fully determine whether you are able to take part in the study. You can withdraw at any point.

If you are not able to take part in this research study, there may be other opportunities for you to take part in different studies.

To find our more about other research opportunities visit our research finder main page.

You may be able to join this study if all of these apply:

Any age above 18 years

Diagnosis of IPF

Suffering from bothersome cough

You will not be able to join the study of any of the following applies:

Diagnosis of sleep apnea

On continuous oxygen therapy for longer than 16 hours per day

Females who are currently pregnant or breastfeeding

What difference could taking part make?

As with all trials with new potential treatments, there is no guarantee that it will work. Currently, nothing is approved to treat chronic cough in IPF and continued research of nalbuphine ER may help you and other people with IPF in the future.

Where does the study take place?

Study locations











This study is recruiting patients across the UK.

Click here for all sites currently recruiting. Please note, travel reimbursement may be available.

How to take part

Speak to your healthcare team about this study or visit to find out more.

Further information

This page is a summary which provides information about an opportunity to participate in research. More detailed information about the study can be found via the following the links and through contacting the research team.

If you have any questions about this research study, please speak to your medical team.

This study is supported by

Trevi Therapeutics
Study ID number:
NCT05964335 *

APF does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators.

Every effort is made to keep these details up to date. If you are aware of any inaccuracies, please email