What next?
What next?
About this study
Pirfenidone is an antifibrotic medication that is often prescribed orally for people with IPF. The drug requires a large dose to make sure that enough reaches the lungs. This can cause significant side effects including abdominal pain, diarrhoea, sensitivity to sunlight, rashes, fatigue and liver problems. As a result of this, people with IPF often don't tolerate the drug or it has a large impact on quality of life.
Researchers have remade the drug so that it can be inhaled using a nebuliser. This means that small inhaled doses of pirfenidone can directly reach the lungs.
The ATLAS study aims to find out if inhaled pirfenidone is well tolerated and as effective as the oral medication.
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?
The study will involve you being assigned to one of 2 groups. Each group will have a different dose of the inhaled pirfenidone, which you will be asked to take twice per week for 72 weeks. This will be through using an eFlow nebuliser. If you also struggle with a cough that impacts your ability to complete the nebulizer dose, then you will also be provided with salbutamol.
You will be given training for how to use the nebulizer at your first visit to the hospital clinic. The clinic staff will then call you by telephone, one week after the first dose to see how you are getting on. For the first 24 weeks, you will visit the hospital once a month. After 24 weeks, until the end of the study at 72 weeks, you will receive a monthly phone call to check with how you are managing, plus a hospital visit every 3 months.
Summary of involvement
Study duration on 72 weeks
Inhaled pirfenidone twice per week using a nebuliser
Regular hospital visits and phone calls from the clinical team to check how you are managing
Can I take part?
You may be able to take part if you are aged 40 years and over, and have a diagnosis of IPF. You must not be taking oral antifibrotic medication, such as nintedanib or prifenidone.
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 research 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.
Aged 40 years and over
Not taking oral nintedanib or pirfenidone
Diagnosis of IPF
Symptoms of IPF for at least 12 months, even if diagnosis was made within this time
There is also a set criteria for lung function test results, but this will be discussed with the research team
Significant worsening of IPF symptoms between the initial assessment and the start of the study
Hospital admission due to an IPF acute exacerbation within the last 3 months
Pulmonary fibrosis which is not IPF and has a known cause, such as drugs, asbestos, radiation, auto-immune disease related or domestic birds
Another diagnosis of a chronic respiratory disease, such as asthma or COPD
What difference could taking part make?
Taking part in this study will help researchers to understand if inhaled pirfenidone is a suitable and effective treatment option for people with IPF.
Where does the study take place?
Study locations
UK
How to take part
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
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