ATLAS Study: investigating if inhaled pirfenidone can help people with IPF

Upcoming study
Expected to open January 2019
This study is currently recruiting
Expected to close October 2021
This study is closed
This study closed in October 2021
We will update this page with study results when available.
Information on study results are included below
This study closed in October 2021

What next?

Original listing:

What next?

Original listing:

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 and maximise the effect on the lung scarring.

The ATLAS study aims to find out if inhaled pirfenidone is well tolerated and as effective as the oral medication.

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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 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.

You may be able to join this study if all of these apply:

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

You will not be able to join the study of any of the following applies:

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 research provides the opportunity to have an active involvement in your healthcare, help you to understand the disease more and the effects it has on your day to day life. Research studies, such as this, have the potential to help develop new treatment options that could help improve the quality of people’s lives for those with PF, both now and in the future.

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

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 and contact the researchers directly via:

This study is supported by

Avalyn Pharma
Study ID number:
ACTRN12618001838202

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