What next?
What next?
About this study
FIBRONEER-IPF and FIBRONEER-ILD were previous phase 3 clinical trials looking at a drug called nerandomilast. Results showed that there was a slower rate of lung function decline for those taking the drug compared to those who were taking a placebo. The FIBRONEER-ON study is a follow up study to look at the longer term impact of the drug.
The aim of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, or there is a need to go to the hospital, or until an individual dies.
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 asked to take the drug, nerandomilast, as tablets for up to 1 year and 10 months. You will be able to also continue with your regular treatment for pulmonary fibrosis during the study.
You will have regular visits to the hospital. During these visits, the healthcare team will collect information on any health problems that you are experiencing, and you will also regularly have lung function tests.
Summary of involvement
Taking daily tablets containing nerandomilast
Regular hospital check-ups
Lung function tests
Can I take part?
You may be able to take part in this study if you have a diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF), and you have previously taken part and completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The previous studies were called FIBRONEER-IPF and FIBRONEER-ILD.
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 the main criteria 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 without this effecting your usual care or treatment.
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.
You must have previously taken part in and completed either the FIBRONEER-IPF or FIBRONEER-ILD study
You must be able to provide informed consent to take part in the trial
If you’re a woman you must be using highly effective birth control
You have another disease that may put you at risk when taking part in this trial
You have had suicidal behaviour or thoughts
You have clinically relevant severe depression
You are expected to receive a lung transplantation
You have a body mass index (BMI) of less than<18.5 kg/m² and experienced additional, unexplained and clinically significant (>10%) weight loss during the first trial
There are also other criteria which will be assessed by the research team
What difference could taking part make?
Taking part in this study could help researchers better understand the long term impact of nerandomilast. The results from the initial FIBRONEER-IPF and FIBRONEER-ILD studies showed that nerandomilast helped to slow the rate of lung function decline. This study will help to find out more about what this means for people taking the drug over a longer period of time.
Where does the study take place?
Study locations
Aberdeen
Birmingham
Bristol
Edinburgh
Exeter
Lancaster
Leeds
Londonderry
London
Manchester
Oxford
Southampton
How to take part
If you would like to take part in the study, please speak to your healthcare and research team who supported you with your previous participation in the FIBRONEER-IPF or FIBRONEER-ILD study.
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
This page provides a lay summary of the research study and does not contain all the information needed to inform decisions about taking part. Please speak to your medical team or the study research team in relation to specific details about the study.
Action for Pulmonary Fibrosis does not endorse or recommend any specific study. All responsibility for the study remains with the sponsors and investigators. Every effort is made to ensure that these details are correct and are kept up to date. If you are aware of any inaccuracies, please email research@actionpf.org