Treating people with idiopathic pulmonary fibrosis with the addition of lansoprazole (TIPAL)
Idiopathic pulmonary fibrosis (IPF) is a serious lung condition that causes tissue scarring, leading to breathlessness and persistent coughing. Many people with IPF also suffer from acid reflux, where stomach acid travels up into the food pipe. Doctors worry that tiny droplets of this acid can accidentally enter the lungs, causing more irritation and scarring. The TIPAL study is an NHS-supported clinical trial investigating whether an acid-reducing medicine called lansoprazole can slow down the progression of IPF. Participants aged 40 or older will take either lansoprazole or a dummy tablet (placebo) twice a day for 12 months. You will continue to receive your usual standard NHS lung care throughout. By checking your lung function, cough, and symptoms over the year, researchers hope to find out if treating acid reflux should become a regular part of IPF care.
De un vistazo
¿De qué trata este estudio?
Idiopathic pulmonary fibrosis (IPF) is a long-term lung condition where the tissue inside the lungs becomes thick, stiff, and scarred over time. This makes it harder for the lungs to carry oxygen into the bloodstream, leading to symptoms like shortness of breath, tiredness, and a dry, hacking cough. While treatments exist to help manage IPF, researchers are constantly looking for new ways to protect the lungs and help people stay well for longer.
Doctors have noticed that many people with IPF also experience acid reflux, often felt as heartburn or indigestion. When acid travels up from the stomach, small amounts can sometimes be breathed into the airways without a person even noticing. Over time, this acid may irritate the fragile lung tissue and make scarring worse. Some early evidence suggests that common medicines used to block stomach acid might help shield the lungs and slow down this damage.
The TIPAL trial aims to test this idea carefully. By comparing the heartburn medicine lansoprazole against a dummy tablet (called a placebo), researchers can clearly see whether reducing stomach acid truly protects the lungs. The results will provide doctors across the UK with solid evidence to decide whether these everyday medicines should be recommended to everyone living with IPF.
Puntos clave
- The TIPAL trial tests whether the heartburn drug lansoprazole can slow lung scarring in people with IPF.
- Half of the participants take lansoprazole twice daily for 12 months, while the other half take a dummy tablet.
- You will continue receiving your standard NHS lung treatments throughout the study.
- Participation involves breathing tests, answering questionnaires, and attending extra hospital appointments.
- Travel expenses of up to £100 can be reimbursed.
- Joining is completely voluntary, and you can leave the study at any time.
¿Quién puede ser elegible?
This study is open to men and women aged 40 and older who have been diagnosed with idiopathic pulmonary fibrosis (IPF) by a specialist medical team. If you are already taking standard antifibrotic medicines for IPF, you can usually still join, provided your dose has been steady for at least four weeks.
You cannot take part if you already take regular acid-reducing tablets (like omeprazole or lansoprazole) or certain gut medicines, unless you are able to safely stop them before joining without your heartburn returning. You must also be well enough to complete standard blowing tests (breathing tests).
People who have had a serious chest infection (including COVID-19) in the four weeks before screening, or who have another major lung condition that affects their symptoms, will not be able to take part.
¿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.
- I am aged 40 or over.
- I have a confirmed diagnosis of idiopathic pulmonary fibrosis (IPF).
- I am able to perform routine lung function (breathing) tests.
- I am not currently taking regular acid-reflux tablets (or can safely stop them under medical advice).
- I have not had a serious chest infection (including COVID-19) in the past 4 weeks.
- I do not have another major lung disease alongside IPF.
¿En qué consiste la participación?
Taking part in the TIPAL study lasts for 12 months. You will be randomly assigned by a computer to take either lansoprazole tablets or matching dummy tablets (placebo) twice every day. Neither you nor your study doctor will know which tablet you are receiving, which keeps the test fair.
You will need to attend extra hospital visits alongside your routine appointments. During these visits, the research team will check your breathing using spirometry (blowing into a tube), collect small blood samples, and ask you to complete surveys about your cough, sleep, and overall quality of life. If you have a troublesome, long-standing cough, you may also be invited to wear a small, simple monitor for 24 hours to count how often you cough.
Throughout the year, the team will closely monitor your health and any side effects. You can claim back your travel costs up to a total of £100.
Riesgos y beneficios potenciales
Locations (61)
- Hospital Universitario de Norfolk y NorwichApproximateNorwich, England
- Queen Elizabeth Hospital BirminghamApproximateBirmingham, England
- Central Manchester University Hospitals NHS Foundation TrustSolo ciudadManchester, England
- University Hospital AintreeApproximateLiverpool, England
- Royal Papworth Hospital Nhs Foundation TrustSolo ciudadCambridge, England
- Hospital Royal BromptonNo verificadoLondon, England
- Hospital FreemanNo verificadoNewcastle upon Tyne, England
- Western Health & Social Care TrustNo verificadoDerry, Northern Ireland
- Leicester Royal InfirmaryNo verificadoLeicester, England
- Hospital General de WestmorlandNo verificadoKendal, England
- Hospital SouthmeadNo verificadoBristol, England
- New Cross HospitalNo verificadoWolverhampton, England
Preguntas comunes
What is lansoprazole?
Lansoprazole is a widely prescribed medicine called a proton pump inhibitor (PPI). It works by reducing the amount of acid your stomach makes, and it is commonly used to treat heartburn, indigestion, and acid reflux.
Will I have to stop my regular IPF medicines?
No. You will continue to take your normal approved IPF medications just as you usually do. The trial tablet is an 'add-on' treatment.
What is a placebo and why is it used?
A placebo is a dummy tablet that looks identical to the real medicine but contains no active ingredients. Using a placebo helps researchers know whether any improvements or side effects are truly caused by the lansoprazole.
What happens if I get heartburn during the trial?
The research team will give you clear guidance and an information leaflet on what to do if you experience heartburn or reflux symptoms while in the study.
¿Puedo abandonar el estudio si cambio de opinión?
Yes, absolutely. You can withdraw from the study at any point without needing to give a reason. Leaving will not affect the standard NHS care you receive.
Cómo obtener más información
Izobel Clegg
Siempre hable con su médico de cabecera o especialista antes de decidir participar en un estudio.
Discusión
Discusión comunitaria
Impulsado por nuestro foro en community.patient.info. Por favor, sea respetuoso — esto no es un consejo médico.