What next?
What next?
About this study
Scientists are investigating the causes of pulmonary fibrosis to help develop new treatment options. Higher levels of certain molecules in the lungs are related to the development of pulmonary fibrosis. Higher levels of a molecule called lysophosphatidic acid, (LPA), is an example. The idea is that injury to the lungs the production of this molecule leading to more scarring of the lungs. A new drug BMS-986278 may help to block this process and may slow down lung function decline.
In this next phase of research, scientists want to find out more about the safety and effectiveness of the drug in a larger number of people living with progressive pulmonary fibrosis and investigate the potential effects on lung function decline.
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 randomly put into 1 of 3 groups.
- Group 1 will be given a lower dose of the study drug
- Group 2 will be given a higher dose of the study drug
- Group 3 will be given a placebo. This is a look like the treatment but will not contain any of the study drug.
You will be asked to take a tablet twice daily for the duration of the study.
At different times during the study, you will have breathing tests, scans of your lungs, and other medical tests. You will be asked to fill out questionnaires about cough, tiredness, and the impact of pulmonary fibrosis on you.
Summary of involvement
Participation for up to 4 years
Assigned to one of three groups to either receive the study drug or a placebo
Take a tablet twice daily
Breathing tests
High resolution computed tomography (HRCT) scan
Other medical tests
Questionnaires
Can I take part?
You may be able to take part if you have progressive pulmonary fibrosis (PPF) and are aged 21 years and over. If you are currently receiving treatment for your PPF, such as the antifibrotic medication nintedanib or pirfenidone, then you must have been on a stable dose for at least 90 days.
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.
Aged 21 years and over
Progressive pulmonary fibrosis
If taking antifibrotics (nintedanib or pirfenidone) you must be on a stable dose for at least 90 days
OR
If not taking antifibrotics (nintedanib or pirfenidone), you must not have taken these for the past 28 days
Highly effective forms of contraception must be used, if applicable
Diagnosis of IPF (there is a separate study specifically for people diagnosed with IPF)
Recent history of a stroke or mini stroke within the last 3 months
Significant heart disease
Cancer within the last 5 years
What difference could taking part make?
Taking part in this study will help researchers to understand if the new drug could be an effective treatment option which slows down lung function decline.
Where does the study take place?
Study locations
Birmingham
Bristol
Cambridge
Peterborough
Dundee
Edinburgh
London
Southampton
Nottingham
Exeter
South Shields
Leeds
Cottingham
Oxford
Please note that some sites are not yet open to recruitment, but will be in due course. We aim to update this information, when it is available.
How to take part
Please speak to your medical team about taking part or contact the research team directly to express your interest 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.
Clinical.Trials@bms.comThis 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