What next?
What next?
About this study
Some people with fibrotic interstitial lung diseases (ILD) have normal oxygen levels at rest, but experience low oxygen levels at night whilst sleeping. Previous research has shown that people who experience this can have poorer disease outcomes. We do not know why this is or the nature of the full impact.
This research study will look at oxygen levels at different times of the day and night, and whilst exercising. It will help to improve our understanding of ILD, and may give us a better idea of why some people suffer with fibrotic ILD that gets worse over time.
The research team aims to measure oxygen levels at night when people are asleep and during 6-minute walk tests. Measuring oxygen levels when walking can help to better identify people with fibrotic ILD at risk of clinical deterioration compared to the current standard assessments within clinical practice.
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?
At the start of the study, you will be assessed clinically at Guy's Hospital or King's College Hospital in London when you will be given lung function tests, 6-minute walk tests, blood tests, an overnight oximetry test, and an echocardiogram. You will also be asked to complete health status questionnaires.
The clinical assessment, lung function tests, 6-minute walk test and health status questionnaires are repeated after 6 and 12 months.
These tests are all performed routinely at participating centres and can be combined with your usual hospital visits.
After 3 years from when you started taking part in the study, there will be a remote assessment of your medical records. You will not be required to attend the hospital in person.
Summary of involvement
Lung function tests (breathing tests)
6-minute walk tests
Blood tests
Overnight oximetry test
Echocardiogram where indicated
Health status questionnaires
Can I take part?
You may be able to take part if you have a diagnosis of fibrotic 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 have a specialist ILD centre multidisciplinary diagnosis of any form of fibrotic interstitial lung disease (ILD)
You have significant cardiovascular disease including heart valve disease or heart failure
You have right heart catheter proven pulmonary hypertension
You have known sleep apnoea and are recieving treatment
You have musculoskeletal problems that stop you from walking for 6 minutes at your own pace
What difference could taking part make?
This study will help researchers to understand more about fibrotic interstitial lung diseases and how oxygen levels at different times can impact the progression of disease.
Where does the study take place?
Study locations
London
How to take part
If you are interested in taking part please speak to your healthcare team, if you are currently receiving care at Guy's Hospital or King's College Hospital. If you are currently receiving care at another hospital, but would be willing and are able to travel to the research site, please contact the research team via email: Respiratoryresearchteam@gstt.nhs.uk
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.
Respiratoryresearchteam@gstt.nhs.ukThis 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.
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 ensure that these details are correct and are kept up to date. If you are aware of any inaccuracies, please email research@actionpf.org