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Background
Idiopathic pulmonary fibrosis (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 that stop stomach acid production, including proton pump inhibitors (PPIs) such as Lansoprazole, 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, the researchers will be able to recommend whether or not IPF patients should take PPIs.
Who can participate?
Patients aged 40 years or above with a diagnosis of idiopathic pulmonary fibrosis. 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.
What does the study involve?
At the beginning of the study, the researchers will ask patients to perform breathing tests, and ask those with a cough to use a device to count the number of times they cough in 24hours. The researchers 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, the researchers will repeat these tests and analyse the results. The researchers will record any side effects people may get. If people suffer side effects, they can reduce the dose.
What are the possible benefits and risks of participating?
Benefits
There is no guarantee that the study will help participants personally, but the information we get from this study will improve our ability to treat patients with pulmonary fibrosis in the future.
Risks
Participants may not get the active treatment, lansoprazole, and may receive the dummy treatment, placebo. However participants will still receive any approved treatment for pulmonary fibrosis from their doctor. Participants will need to complete study visits, either at virtually at home or at their hospital, in addition to their routine clinic visits. Although participants will receive reimbursement for their travel expenses up to £100 in total for any visits attended in person.
The blood tests may cause discomfort and bruising. Questionnaires will take time to complete. Breathing tests may cause slight breathlessness, difficulty breathing or chest discomfort for a few minutes at the most following the tests. Participants may experience side effects from the active treatment. However, participants are free to reduce their dose of trial treatment under the guidance of their doctor/research team. Participants are also free to withdraw from the study at any time without giving a reason and without any effect on the standard of care participants receive.
Who is running the study?
Norfolk and Norwich University Hospitals NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
June 2021 to August 2024
Who is funding the study?
This study/project is funded by the NIHR Health Technology Assessment Programme (NIHR 127479)