What next?
What next?
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.
There are many different types of research. These studies might ask participants to test different treatments, devices, or complete questionnaires. Some studies may not require any involvement from people affected by PF, but instead look at cells in a lab environment, animal models, or utilise computer modelling.
A study involving people can be:
- Interventional – participants are given an active treatment decided by researchers. This could be a change in medication or lifestyle (e.g. exercise, diet, complementary wellbeing therapy, or symptom management). These are commonly known as clinical trials.
- Observational – participants are assessed for specific changes over time, but researchers do not alter their standard treatment or care (e.g. questionnaires to understand the impact of symptom, or patient registries that track trends in how disease affects people or the services that are provided).
There are 3 main phases of clinical trials:
- Phase 1 is the earliest stage of research, where there is often a focus on understanding if the treatment is safe or if it causes any side effects.
- Phase 2 still focuses on safety and side effects, but also tries to find out more about what is the best dose.
- Phase 3 often compares the new treatment to existing treatments or lookalike medications.
As drugs or interventions move into the different phases, the number of people taking part will increase. Not all studies will make it to the later phases, especially if the intervention is not found to be safe or effective in phase 1 and 2.
The recruitment aim is the number of people that researcher want to take part in the research study.
What is involved?
You will be assigned to one of four groups in this trial:
- placebo tablets twice a day
- oral nalbuphine ER 27mg twice a day
- oral nalbuphine ER 54mg twice a day
- 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 out more about other research opportunities visit our research finder main page.
Any age above 18 years
Diagnosis of IPF
Suffering from bothersome cough
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
Cambridge
Cottingham
Edinburgh
Londonderry
London
Manchester
Norwich
Nottingham
Oxford
Southampton
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 www.uk.coralcoughtrial.com 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
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 research@actionpf.org