What next?
What next?
About this study
There are currently limited tests that can predict disease progression for people affected by IPF and limited understanding of what the response to treatment will be like for each individual.
A blood biomarker, called Krebs von den Lungen-6 (KL-6) is higher in people that have IPF, compared to those who do not have the disease. Biomarkers are a broad range of measures that capture what is happening in the body at that time point. It is unclear, if blood levels of KL-6 change over time in people with IPF or in response to treatment with antifibrotics.
This study aims to monitor blood levels of the blood biomarker over 12 months in people who are newly diagnosed with IPF. This will help to understand if changes are related to treatment with antifibrotics and/or progression of IPF over time.
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 have blood tests, which will look at the levels of the KL-6 biomarker. Lung function tests, symptoms and antifibrotic treatment will be recorded at different time points over 12 months.
Summary of involvement
Blood tests
Lung function tests
Can I take part?
You may be able to take part if you have a diagnosis of IPF and are aged 18 years and over.
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 clinical trial 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 our more about other research opportunities visit our research finder main page.
Over the age of 18 years old
Confirmed multi-disciplinary team diagnosis of IPF
Another significant respiratory condition that is not IPF
Current smoker or smoked within the last 4 weeks
Respiratory tract infection within the last 4 weeks
Long term use of oral corticosteroids or immunosuppression within the last 4 weeks
Current participation in other research
Specific lung function criteria which will be assessed by the research team
What difference could taking part make?
Taking part in this study will help researchers to gain a better understanding of KL-6 level in the blood of people with IPF over time. It may help to provide improved patient care in the future that will enable prediction of disease progression and individual response to treatment.
Taking part in research has the potential to make a difference for people who have IPF now and for future generations.
Where does the study take place?
Study locations
Manchester University Hospitals NHS Foundation Trust
How to take part
Please speak to your healthcare team if you are interested in taking part..
Further information
The summary on this page 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
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