RecruitingPHASE3INTERVENTIONAL

Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole

This study is investigating if a common stomach acid medicine, lansoprazole, can help people with Idiopathic Pulmonary Fibrosis (IPF). IPF is a serious lung condition that causes scarring and makes breathing difficult. Many people with IPF also experience acid reflux, where stomach acid goes up into their gullet and potentially into their lungs, which some experts believe could worsen IPF. Lansoprazole belongs to a group of medicines called 'proton pump inhibitors' (PPIs) that reduce stomach acid. This research aims to find out if taking lansoprazole regularly can slow down the progression of IPF. We will study about 298 IPF patients across the UK over 12 months to see if this medicine makes a difference to their breathing, cough, and overall well-being. Ultimately, the results will help guide doctors on whether to recommend PPIs for IPF patients.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Enrolment target

298

Start

16 Jun 2021

Estimated completion

28 Feb 2026

Idiopathic Pulmonary Fibrosis

What is this study about?

Idiopathic Pulmonary Fibrosis (IPF) is a lung condition where the lungs become scarred and stiff, making it harder to breathe. It's called 'idiopathic' because the cause isn't fully known. People with IPF often have a problem called reflux, where stomach acid travels up towards the throat. It's thought that this acid might sometimes get into the lungs, potentially causing more damage and making IPF worse. Medicines called proton pump inhibitors (PPIs), like lansoprazole, work by reducing the amount of acid your stomach makes. They are commonly used to treat heartburn and other reflux symptoms.

At the moment, doctors aren't sure if PPIs can actually help slow down the progression of IPF itself, even though some studies have suggested it might. This is a really important question because if PPIs do help, it could offer a simple way to improve the health of many IPF patients. This study aims to get a clear answer. By carefully comparing patients who take lansoprazole with those who take a dummy pill (placebo) over a year, we hope to find out if this medicine genuinely slows down the lung scarring and improves symptoms like coughing and breathlessness.

The findings from this research will be very valuable. Based on the results, doctors and health organisations will be able to make firm recommendations about whether PPIs should be a standard part of treatment for people with IPF. This could mean a better quality of life for IPF patients in the future.

Key takeaways

The study aims to see if a stomach acid medicine (lansoprazole) helps people with IPF.
IPF causes lung scarring, and stomach acid reflux might make it worse.
Participants will take study tablets (lansoprazole or dummy) twice daily for 12 months.
You'll perform breathing tests and answer questions about your cough and breathlessness.
Results will help doctors decide if PPIs should be a standard IPF treatment.
Most appointments can be done from home.

Who may be eligible?

To take part in this study, you need to be at least 40 years old and have a confirmed diagnosis of Idiopathic Pulmonary Fibrosis (IPF). You might already be taking other approved medicines for your IPF, as long as you've been on them for at least four weeks and aren't planning to change them soon.

There are also some reasons why you wouldn't be able to join. For example, if you can't carry out breathing tests reliably, or if you've had a chest infection recently (within the last four weeks). You also can't be taking certain other medicines, including existing anti-reflux drugs within two weeks of starting the study.

Also, if you have other serious health problems, such as severe liver or kidney disease, or certain conditions of the gullet like Barrett's oesophagus, you wouldn't be suitable. If you are allergic to PPIs or need to take them permanently for a medical condition, you also can't take part. However, if you are currently taking PPIs but can stop them without your heartburn returning, you might still be able to join.

Quick self-check

Are you 40 years old or older?
Do you have a firm diagnosis of Idiopathic Pulmonary Fibrosis (IPF)?
Are you able to do breathing tests accurately?
Have you not had a recent chest infection (in the last 4 weeks)?
Are you NOT currently taking anti-reflux medicines (unless you can stop without issues)?
Do you NOT have serious liver, kidney, or gullet conditions?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll be one of almost 300 IPF patients across about 37 hospitals in the UK. At the start, we'll give you equipment to do weekly breathing tests at home. If you have a cough, we'll also ask you to use a special device to count your coughs over 24 hours. You'll answer a couple of questions about your cough and breathlessness, and fill out some questionnaires about your cough, IPF, sleep, and general health.

You'll be given study tablets to take twice a day for 12 months. These will either be lansoprazole (the active medicine) or dummy tablets, decided by chance, and neither you nor your doctor will know which you're taking. You'll also get a leaflet about what to do if you have reflux symptoms. Throughout the study, we'll keep an eye on any side effects you might experience, and if they're troublesome, you can reduce your dose.

Many of your study check-ups and appointments can happen remotely (online or by phone), so you might not need to travel to the hospital much. At the end of the 12 months, we'll repeat all the initial tests and questionnaires to see how you've been. The whole study will last for one year.

Potential risks and benefits

Potential benefits of taking part include contributing to important research that could improve care for all IPF patients in the future. If you receive lansoprazole, there's a chance it could slow down your IPF progression and ease symptoms like reflux, cough, and breathlessness, though this isn't guaranteed. On the other hand, if you receive the dummy tablets, you won't get any direct benefit from the study medicine. Potential risks include side effects from lansoprazole, although it's a commonly used medicine. These are usually mild, but we will monitor you closely, and you can reduce your dose if needed. There's also the time commitment involved with the tests and questionnaires. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (57)

Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, United Kingdom· Recruiting
NHS Grampian
Aberdeen, United Kingdom· Recruiting
Northern Health and Social Care Trust
Antrim, United Kingdom· Recruiting
Hampshire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom· Completed
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom· Recruiting
University Hospitals Birmingham NHS Foundation Trust (QEHB)
Birmingham, United Kingdom· Recruiting
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom· Recruiting
East Lancashire Hospitals NHS Trust
Blackburn, United Kingdom· Completed
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom· Not yet recruiting
North Bristol NHS Trust
Bristol, United Kingdom· Completed
West Suffolk NHS Foundation Trust
Bury St Edmunds, United Kingdom· Recruiting
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom· Recruiting

+45 more sites — see the official record for the full list.

Common questions

What is Idiopathic Pulmonary Fibrosis (IPF)?

IPF is a serious lung disease where the lungs become scarred and stiff over time, making it hard to breathe.

What is lansoprazole?

Lansoprazole is a medicine that reduces stomach acid, often used to treat heartburn and acid reflux.

Will I know if I'm taking the medicine or a dummy pill?

No, neither you nor your doctor will know if you're taking lansoprazole or a dummy pill during the study. This helps make the results fair.

How long will the study last?

If you join the study, you'll be taking the tablets and doing tests for 12 months.

Can I leave the study if I change my mind?

Yes, you are free to leave the study at any time, for any reason, without it affecting your routine medical care.

How to find out more

Emily Harvey

emily.harvey@uea.ac.uk 01603 591224 Official trial record

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