Active not recruitingOBSERVATIONAL

Exhaled Breath Analysis Using eNose Technology as a Biomarker for Diagnosis and Disease Progression in Fibrotic ILD

This study, called ILDnose, is looking at a new, simple way to help people with lung scarring. Researchers are using a device called an "eNose" to analyse people's breath. They want to see if the eNose can accurately tell if someone has lung scarring and what type it is. They also hope it can show if the condition is getting worse or if treatments are helping. This is a non-invasive test, meaning it doesn't involve needles or surgery, and it's designed to be quick and easy for patients. The study also checks how well some questionnaires work for people with lung scarring.

At a glance

Status

Active not recruiting

Sponsor

Erasmus Medical Center

Enrolment target

600

Start

01 Nov 2020

Estimated completion

31 Dec 2026

Pulmonary Fibrosis

What is this study about?

Imagine a special device that could "sniff" your breath for clues about your health. That's exactly what researchers are trying to do in a study called ILDnose. They're using something called an "eNose" (short for electronic nose) to analyse the breath of people with pulmonary fibrosis.

Pulmonary fibrosis is a condition where scars develop in the lungs, making it harder to breathe. This study wants to find out if the eNose can be a helpful new tool. Firstly, they want to see if it can accurately diagnose pulmonary fibrosis and tell the difference between different kinds of lung scarring. Secondly, they're hoping the eNose can show if the condition is getting worse over time or if the treatments people are taking are making a difference.

This is a big study involving many hospitals and clinics, and it follows people over time. The main goal is to find easier and earlier ways to understand and manage pulmonary fibrosis without needing invasive tests. It's an exciting area of research that could potentially make a real difference for patients.

Key takeaways

This study uses a simple breath test (eNose) for lung scarring (pulmonary fibrosis).
It aims to diagnose and track the condition, and see how well treatments are working.
The eNose measurement is quick, easy, and non-invasive.
There are no known risks to taking part.
Your involvement helps researchers improve care for future patients.

Who may be eligible?

This study is looking for people who have been diagnosed with a type of lung scarring called fibrotic interstitial lung disease (ILD). This diagnosis would have been confirmed by a team of specialists.

About half of the people joining the study will have been diagnosed within the last six months (these are called 'incident' patients), and the other half will have had their diagnosis for longer ('prevalent' patients).

To join, you also need to have had a specific type of scan, called an HRCT scan, within the last year that clearly shows fibrosis (scarring) in your lungs. Regardless of the size of the scarred area, you could still be eligible.

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.

Have you been diagnosed with fibrotic ILD (lung scarring)?
Was your diagnosis confirmed by a team of specialists?
Have you had an HRCT scan in the last year showing lung fibrosis?
Can you physically perform a simple breathing test?
Are you able to avoid alcohol for at least 12 hours before the measurement?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your involvement will be quite straightforward. You'll have an eNose measurement during or right after one of your regular clinic visits, at the same location. Before the measurement, you'll rinse your mouth with water.

The eNose measurement itself is non-invasive and takes only about 5-10 minutes. You'll take five normal breaths, then a deep breath in, hold it for five seconds, and then breathe out slowly until your lungs are empty. This is done twice, with a short break in between.

After the eNose measurement, you'll fill out a quick survey about recent food intake, smoking habits, medications, other health conditions, and any signs of a respiratory infection. You'll also complete two short questionnaires about how your lung condition affects your daily life and any changes in your quality of life since your last visit. Over the course of the study, researchers will also collect information from your medical records, like your age, gender, diagnosis details, and lung function tests. This will happen at the start of the study, at 6 months, and at 12 months.

Potential risks and benefits

There are no known risks associated with taking part in this study, and the procedures are designed to be very simple and cause minimal discomfort. The eNose measurement is non-invasive and quick. While there's no direct benefit to you from taking part, your contribution will help researchers better understand pulmonary fibrosis and potentially develop new diagnostic tools and ways to monitor the condition, which could help future patients. You are free to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (5)

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

Royal Prince Alfred Hospital
Verified postcode
Camperdown, Australia
University Lyon 1, Louis Pradel hospital, Lyon. FranceService de pneumologie, hôpital Louis Pradel
Verified postcode
Lyon, France
Thoraxklinik Heidelberg
Verified postcode
Heidelberg, Germany
Erasmus MC
Verified postcode
Rotterdam, Netherlands
Royal Brompton Hospital
Verified postcode
London, United Kingdom

Common questions

What is an eNose?

An eNose is a device that can 'smell' and analyse the different chemicals in your breath, similar to how a dog can smell things. Scientists hope it can find specific patterns related to your health.

Is the eNose test painful or uncomfortable?

No, the eNose test is not painful. It's a simple breathing test, much like blowing into a mouthpiece, and it only takes a few minutes. It's designed to be as easy as possible.

How long will I need to be involved in the study?

The study will collect information for about 12 months in total, by looking at your medical records at the start, 6 months, and 12 months. The actual eNose measurements and questionnaires take very little time during your clinic visits.

Will this study affect my usual treatment for pulmonary fibrosis?

No, participating in this study will not change or interfere with your regular medical care or treatments for pulmonary fibrosis. It's an additional investigation.

Do I have to do anything special before the eNose test?

You'll be asked to rinse your mouth with water three times before the test. You'll also be asked about what you've eaten recently, your smoking history, and medication use.