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.
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¿De qué trata este estudio?
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.
Puntos clave
- 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.
¿Quién puede ser elegible?
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.
¿Podría este estudio ser adecuado para ti?
Responde estas preguntas rápidas para ver si puedes ser elegible. Esto es solo una guía: el equipo de investigación toma la decisión final.
- 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?
¿En qué consiste la participación?
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.
Riesgos y beneficios potenciales
Locations (57)
- Norfolk and Norwich University Hospitals NHS Foundation TrustCódigo postal verificadoNorwich, United Kingdom· Reclutamiento
- NHS GrampianCódigo postal verificadoAberdeen, United Kingdom· Reclutamiento
- Northern Health and Social Care TrustCódigo postal verificadoAntrim, United Kingdom· Reclutamiento
- Hampshire Hospitals NHS Foundation TrustCódigo postal verificadoBasingstoke, Reino Unido· Completado
- Royal United Hospitals Bath NHS Foundation TrustCódigo postal verificadoBath, United Kingdom· Reclutamiento
- University Hospitals Birmingham NHS Foundation Trust (QEHB)Código postal verificadoBirmingham, Reino Unido· Reclutamiento
- University Hospitals Birmingham NHS Foundation TrustCódigo postal verificadoBirmingham, Reino Unido· Reclutamiento
- East Lancashire Hospitals NHS TrustCódigo postal verificadoBlackburn, United Kingdom· Completado
- Blackpool Teaching Hospitals NHS Foundation TrustCódigo postal verificadoBlackpool, United Kingdom· Aún no reclutando
- North Bristol NHS TrustCódigo postal verificadoBristol, Reino Unido· Completado
- West Suffolk NHS Foundation TrustCódigo postal verificadoBury St Edmunds, United Kingdom· Reclutamiento
- Fideicomiso de la Fundación del Hospital Royal Papworth NHSCódigo postal verificadoCambridge, Reino Unido· Reclutamiento
Preguntas comunes
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.
¿Cuánto tiempo durará el estudio?
If you join the study, you'll be taking the tablets and doing tests for 12 months.
¿Puedo abandonar el estudio si cambio de opinión?
Yes, you are free to leave the study at any time, for any reason, without it affecting your routine medical care.
Cómo obtener más información
Emily Harvey
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
¿Interesado en participar?
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Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.