RecruitingOBSERVATIONAL

A Pilot Study to Assess Body Mass Composition Measurement Using BIA and Muscle Ultrasound in IPF and PPF Patients on Anti-fibrotic Medications

This study wants to learn more about how anti-fibrotic medicines, used for lung conditions like Idiopathic Pulmonary Fibrosis (IPF) and Progressive Pulmonary Fibrosis, might change the amount of muscle and fat in your body. These medicines can sometimes cause tummy upsets like nausea or diarrhoea, which could lead to changes in your body shape. Traditional ways of checking like weighing yourself or calculating your Body Mass Index (BMI) don't always show these subtle changes. The study will use quick and easy methods, like special body scanners (BIA) and ultrasound scans of your thigh muscles, to see if these changes occur. This research aims to understand how these important lung medicines affect your body composition.

At a glance

Status

Recruiting

Sponsor

Royal Brompton & Harefield NHS Foundation Trust

Enrolment target

Start

09 Sep 2025

Estimated completion

01 Apr 2026

Idiopathic Pulmonary Fibrosis (IPF)Progressive Pulmonary Fibrosis

What is this study about?

If you have a lung condition like Idiopathic Pulmonary Fibrosis (IPF) or Progressive Pulmonary Fibrosis, you might be taking anti-fibrotic medicines such as nintedanib or pirfenidone. These medicines are really important for managing your condition, but they can sometimes cause side effects like feeling sick, losing your appetite, or having diarrhoea. Doctors have noticed that these side effects might lead to changes in how much muscle and fat people have, which isn't always obvious just from their weight.

This study is a first look, or 'pilot study', to see if these changes in body muscle and fat can be easily measured using some special tools. It's important to understand this because knowing how these medicines affect your body could help doctors provide even better care in the future. The study will use two main methods: a body scanner called Bioimpedance Analysis (BIA), which is quick and simply involves placing stick-on pads on your body, and an ultrasound scan to measure the muscle in your thigh. These methods are simple and have been used safely for people with other lung conditions.

Beyond these scans, the study will also take other measurements. This includes measuring around your arm, and asking you to do some simple physical tests like sitting to standing, walking a short distance, and checking your muscle strength. You'll also be asked to complete some questionnaires about your general well-being, how active you are, and any tummy symptoms you might be experiencing. Finally, you'll be asked to keep a food diary for three days. All these tests will be done before you start your anti-fibrotic medicine and then again after about four months of taking it, so researchers can see if there are any changes over time.

Key takeaways

Study examines impact of lung medicines on body muscle and fat.
Uses simple scans (BIA, muscle ultrasound) to measure changes.
Compares body composition before and 4 months after starting medication.
Also includes physical tests, questionnaires, and a food diary.
Aims to improve understanding of anti-fibrotic medicine effects.
No changes to your regular medical treatment or medication.

Who may be eligible?

This study is looking for people who have been diagnosed with Idiopathic Pulmonary Fibrosis (IPF) or Progressive Pulmonary Fibrosis. To join, you must be about to start a new anti-fibrotic medicine (either nintedanib or pirfenidone) and be over 18 years old. You also need to be able to understand the study and agree to take part voluntarily.

There are certain reasons why you might not be able to join. For example, if you are currently using a feeding tube, have lost a lot of weight (more than 10%) in the last 3 to 6 months, or have major muscle or bone problems that could affect the study's measurements. You also can't take part if you've already used anti-fibrotic medicines before or are taking a high dose of a steroid medicine called Prednisolone (more than 10mg daily).

Other reasons that would prevent you from joining include having an implanted heart device like a pacemaker or defibrillator, severe heart failure, being pregnant, or if you are receiving end-of-life care with a very short life expectancy (less than 6 weeks).

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.

Do you have Idiopathic Pulmonary Fibrosis or Progressive Pulmonary Fibrosis?
Are you about to start a new anti-fibrotic medicine (nintedanib or pirfenidone)?
Are you over 18 years old?
Have you not lost more than 10% of your weight in the last 3-6 months?
Do you *not* have an implanted heart device (like a pacemaker)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll have two main visits to the clinic. The first visit will be just before you start your new anti-fibrotic medicine. During this visit, you'll have various tests and measurements, including the special body scanner (BIA) and a muscle ultrasound. You'll also do some physical tests, answer questionnaires, and be given a diary to record what you eat for three days. You'll then start your anti-fibrotic medication as planned by your doctor.

The second visit will happen about four months after you started your anti-fibrotic medicine. At this visit, you'll repeat all the same tests and measurements from your first visit, including the BIA scan, muscle ultrasound, physical tests, and questionnaires. This allows the researchers to see if there have been any changes since you started your medication. The total time you'd be involved in the study from your first visit to your last is approximately four months.

Potential risks and benefits

Taking part in this study won't directly improve your health, but it could help doctors understand more about how your anti-fibrotic medicines affect your body. This knowledge might lead to better care for people with these lung conditions in the future. The tests involved, like the body scans and ultrasounds, are generally safe and don't involve any needles or harmful radiation. There's a small chance you might feel a bit tired from the physical tests or find the questionnaires take some time. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without it affecting your medical care.

Locations (1)

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

Royal Brompton Hospital
Verified postcode
London, United Kingdom· Recruiting

Common questions

What are 'anti-fibrotic medicines'?

These are medications used to slow down the scarring of the lungs in conditions like Idiopathic Pulmonary Fibrosis.

What is BIA?

BIA stands for Bioimpedance Analysis. It's a quick and simple scan that uses gentle electrical signals to measure your body's fat and muscle.

Will my main treatment for IPF or PPF change?

No, your regular anti-fibrotic medication will be given as prescribed by your doctor as part of your usual care. This study won't change your treatment plan.

How long will each visit take?

The study description doesn't specify exact times for visits, but they will involve multiple tests and questionnaires performed on two separate occasions.

Can my family join me during appointments?

You should check with the study team beforehand, but generally, having a family member or friend with you should be fine.

How to find out more

Jessica Dr Raja

jessica.raja2@nhs.net 07955229245 Official trial record

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