Not yet recruitingOBSERVATIONAL

FIBRotic Interstitial Lung Disease With Nocturnal hypOXaemia and EXercise Induced desaTuRAtion

This study, called FIBRNOX, is for people with a lung condition called fibrotic interstitial lung disease (fILD), also known as pulmonary fibrosis. We know that some people with fILD get worse over time, but we don't fully understand why. This research aims to find out if measuring oxygen levels while sleeping or exercising can help doctors identify patients who might be at a higher risk of their condition worsening. By closely observing around 160 patients, we hope to better understand their condition and improve care.

At a glance

Status

Not yet recruiting

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Enrolment target

160

Start

01 Jul 2024

Estimated completion

01 Jul 2029

Interstitial Lung Disease Fibrosis Lung Pulmonary Hypertension

What is this study about?

This study is called FIBRNOX, and it's looking into a condition called fibrotic interstitial lung disease (fILD), often known simply as pulmonary fibrosis. This is a lung disease where the lung tissue becomes scarred and thickened, making it harder to breathe. We know that for some people with fILD, their condition can get worse over time, causing more breathing problems. However, it's not always clear why this happens to some patients and not others.

Researchers previously found that people with fILD who have normal oxygen levels when resting, but whose oxygen levels drop significantly during sleep or exercise, tend to have poorer health and a shorter life expectancy. This new FIBRNOX study builds on that knowledge. The main goal is to see if regularly checking oxygen levels during sleep or exercise can help doctors spot patients who are more likely to see their condition get worse, or develop other issues like high blood pressure in the lungs (pulmonary hypertension).

By following about 160 patients with fILD and gathering lots of information over time, the study hopes to give us a better understanding of how the disease progresses. This could ultimately help doctors provide more targeted care and support for people living with pulmonary fibrosis.

Key takeaways

This study focuses on understanding why some people with lung scarring (fibrosis) get worse.
It checks how your oxygen levels change during sleep and exercise.
The findings could help doctors identify patients at higher risk of their condition worsening.
You'll have several standard health checks over a year.
Participation involves no new treatments, just observation and tests.
Your regular medical care will continue as normal.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with fibrotic interstitial lung disease (fILD) by a specialist medical team, with at least 10% scarring visible on your lung CT scan. This includes different types of fILD, such as idiopathic pulmonary fibrosis (IPF) and other similar conditions. You'll also need to be able to understand and sign a consent form.

There are some reasons why you might not be able to join. For example, if you're already using long-term oxygen therapy at home, or if you have severe sleep apnoea. Also, if your lung CT scan shows more emphysema (another lung condition) than scarring, or if you have certain heart problems that would make exercise unsafe, you wouldn't be able to take part. It's also important that you can complete a 6-minute walk test and answer health questionnaires.

The research team will carefully review your medical history to make sure the study is right and safe for you. They will explain all the details if you're interested.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with a type of fibrotic interstitial lung disease (like pulmonary fibrosis)?
Are you able to walk for 6 minutes (even if slowly) with no severe pain?
Are you NOT currently using long-term oxygen therapy at home?
Do you NOT have severe sleep apnoea (a condition where your breathing stops and starts during sleep)?
Do you NOT have certain serious heart problems that would make exercise risky?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have several check-ups over an initial year. These check-ups will usually involve standard tests you might already have as part of your regular fILD care. These include breathing tests to check your lung function, special heart scans (echocardiograms), blood tests, and a 6-minute walk test where you walk at your own pace for six minutes. You'll also wear a device overnight to measure your oxygen levels while you sleep, and fill out some questionnaires about your health and how you feel.

You'll have these tests at the very beginning of the study, then again at 6 months, and finally at 12 months. The echocardiogram will only be repeated at 12 months, not at 6 months. After the first year, the research team will continue to check your medical records for another three years to see if there have been any changes in your health or if you've had certain procedures like a right heart catheter (a test for pulmonary hypertension). The total duration for active participation with tests is 12 months, with an additional 3 years of follow-up through your medical records.

Potential risks and benefits

Taking part in this study could help doctors better understand fibrotic interstitial lung disease, which could lead to improved care for patients in the future. While there are no direct benefits to your own health from participating, you will receive regular monitoring and health checks as part of the study. The risks are generally low, as most of the tests are standard and routinely performed for fILD patients. There's a small risk of discomfort or fatigue during the 6-minute walk test or blood draws. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Guy's & St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom

Common questions

What is 'fibrotic interstitial lung disease'?

It's a lung condition where the lung tissue becomes scarred and stiff, making it harder to breathe. It's also known as pulmonary fibrosis.

What does 'observational study' mean?

It means the researchers are watching and collecting information about what happens naturally, without giving any new treatments or medicines. You'll continue with your usual medical care.

Why is measuring oxygen during sleep or exercise important?

The study wants to see if oxygen levels dropping during these times can help predict if your lung condition might get worse, even if your resting oxygen levels are normal.

Will I get any special treatment in this study?

No, this study doesn't involve new treatments. You will receive regular check-ups and standard tests, but your ongoing medical care will remain the same.

How long will I be involved in the study?

You'll have active visits and tests for one year, and then the researchers will follow your medical records for another three years after that.

How to find out more

Alexandra Lawrence, MBBS

alexandra.lawrence@gstt.nhs.uk 02071887188 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.