Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole
Status:
Recruiting
Trial end date:
2024-12-16
Target enrollment:
Participant gender:
Summary
IPF is a progressive scarring lung condition causing coughing and breathlessness. IPF
patients often have reflux disease meaning stomach acid may be breathed into the lungs,
potentially damaging them. Medicines which stop stomach acid production, proton pump
inhibitors (PPIs), can be used to reduce reflux symptoms including heartburn. Some
researchers suggest PPIs also reduce IPF progression.
This research aims to see if IPF progresses slower if treated with PPIs. Based on the
results, we will be able to recommend whether or not IPF patients should take PPIs.
This trial will involve 298 IPF patients from approximately 37 UK hospitals. At the beginning
of the study, we will ask patients to start performing weekly breathing tests at home using
equipment provided, and ask those with a cough to use a device to count the number of times
they cough in 24hours. We will ask them to answer two questions rating their coughing and
breathlessness, and complete questionnaires on their coughing, IPF, sleep habits and general
condition. People will be given a PPI, called lansoprazole, or dummy tablets, twice per day
for 12 months. They will be given a leaflet telling them what to do about reflux symptoms. At
the end of the study, we will repeat these tests and analyse the results. We will record any
side effects people may get. If people suffer side effects, they can reduce the dose.
People taking medicines that interact with PPIs or have other serious medical conditions
won't be able to participate. People receiving PPIs will only be able to participate if they
can stop taking their medication without their heartburn returning.
Phase:
Phase 3
Details
Lead Sponsor:
Norfolk and Norwich University Hospitals NHS Foundation Trust