What next?
What next?
About this study
DROP-FPF is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis (PF).
Interstitial lung abnormalities (ILAs) are changes seen on a CT scan of the lung. These changes can show inflammation and/or scarring (fibrosis). ILAs are not a disease but can be an early sign of lung disease developing. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse.
The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis.
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 put into one of 2 groups randomly, which means the group is chosen by chance. One group will take nerandomilast tablets, and the other group will take placebo tablets. A placebo looks like nerandomilast tablets but do not contain any medicine.
You will take a tablet twice a day for about 2 to 3 years. There is a 3 out of 5 chance that you will receive nerandomilast instead of the placebo.
You will visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, you will also have phone calls with the research staff every 3 months. Doctors will regularly test your lung function and take chest scans to see what happens as a result of taking the medicine. The results are compared between the 2 groups to see if nerandomilast helps. The doctors will also check your health and take note of any unwanted side effects.
Summary of involvement
Study duration for 2 to 3 years
Taking a tablet twice a day
Hospital visits
Lung function tests
High resolution computed tomography (HRCT) scan
Other tests to monitor your health
Questionnaires
Can I take part?
You may be able to take part if you have a family member with pulmonary fibrosis, you are over the age of 40 years and have been told that you have interstitial lung abnormalities.
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 are age 40 years and over of age
You have at least 1 first-degree relative (biological parent, sibling, or child) with confirmed diagnosis of PF
You have had a High resolution computed tomography (HRCT) scan which has showed evidence of ILAs
There are also specific lung function test measures and additional criteria, but these will be assessed by the research team
You have a confirmed diagnosis of pulmonary fibrosis
HRCT findings consistent with probable or definite usual interstitial pneumonia (UIP) pattern
Any medical condition that is known to put you at greater risk of developing pulmonary fibrosis (such as known connective tissue disease)
Prior or current use of nerandomilast, nintedanib, or pirfenidone
Further exclusion criteria also apply, but these will be assessed by the research team.
What difference could taking part make?
This study is being done to find out if a medicine called nerandomilast can help slow down the early lung abnormality changes in the lungs for people who have a close family member with pulmonary fibrosis.
Where does the study take place?
Study locations
Royal Devon and Exeter Hospital
Royal Brompton Hospital
If you are willing and able to travel to the hospital sites, you may still be able to take part.
How to take part
To be confirmed.
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