What next?
What next?
About this study
Antifibrotic medications, such as nintedinib and pirfenidone, that are used for certain types of pulmonary fibrosis can make people feel unwell with nausea, diarrhoea and vomiting. This can lead to changes in weight. Low weight or a reduced amount of muscle can impact the health of people with pulmonary fibrosis and make individuals more vulnerable. It is important that these changes are picked up early, so that support can be provided. Some people may have a normal body weight, but reduced amount of muscle, making it difficult for healthcare professionals to spot.
This study aims to look at how antifibrotic medications used in pulmonary fibrosis, impact the amount of fat and muscle in the body.
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?
If you decide to take part in this study, you will need to attend the hospital twice, once at the start and then again after 4 months. During each visit you will have a thigh muscle ultrasound, bioelectrical impedance analysis (this is a machine that measures fat and muscle in the body), height, weight, and short physical tests to measure your physical strength. You will also be asked questions about your dietary intake, gastrointestinal symptoms, level of physical activity and respiratory symptoms.
Summary of involvement
Study duration of 4 months
Visit the hospital twice
At each visit you will have:
- Thigh muscle ultrasound
- Analysis of your body fat and muscle
- Height & weight
- Short tests to measure your strength
- Questions about your food intake, gastrointestinal symptoms, physical activity and respiratory symptoms
Can I take part?
You may be able to take part if you are aged 18 years and over, have pulmonary fibrosis and are about to start taking antifibrotic medication.
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 be over the age of 18
You have a diagnosis of idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF)
You are about to start taking nintedanib or pirfenidone
You are pregnant
You have heart failure or implantable cardiac devices (e.g pacemaker)
You have lost more that 10% of your body weight in the last 3-6 months
You are currently taking or have previous anti-fibrotic use
What difference could taking part make?
Taking part in this research study will help to understand more about the impact of antifibrotics on muscle and fat in the body. This will help to identify the need for future dietetic interventions and inform strategies for supporting people with pulmonary fibrosis who are taking antifibrotic medications.
Where does the study take place?
Study locations
Royal Brompton Hospital, London
How to take part
If you would like to take part in this study, please contact either Rasleen Kahai or Dr Jessica Raja by emailing: gstt.ild-dietetics@nhs.net
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.
gstt.ild-dietetics@nhs.netThis 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