A UK Study to See if Lansoprazole Slows Down Idiopathic Pulmonary Fibrosis Progression Compared to Placebo
Led by Norfolk and Norwich University Hospitals NHS Foundation Trust · Updated on 2025-12-22
298
Participants Needed
57
Research Sites
N/A
Total Duration
AI-Summary
What this Trial Is About
Idiopathic pulmonary fibrosis IPF is a progressive lung disease causing scarring that leads to coughing and breathlessness. Many IPF patients also have reflux disease, where stomach acid can damage the lungs. This research aims to find out if treating IPF patients with proton pump inhibitors PPIs, which reduce stomach acid, can slow down the progression of IPF. The trial is a randomized, placebo-controlled study involving 298 IPF patients across about 37 UK hospitals.
Participants will be randomly assigned to take either lansoprazole a PPI or dummy tablets twice daily for 12 months. They will start weekly breathing tests at home using equipment provided and, if they have a cough, use a device to count coughs over 24 hours. Participants will complete questionnaires about coughing, breathlessness, sleep habits, and overall health. Some will also wear activity and sleep monitors during cough monitoring sessions. Dose reduction is allowed if side effects occur.
During the study, patients will complete regular questionnaires and provide blood samples for safety checks at 3, 6, 9, and 12 months. Weekly home spirometry will continue for the full year. Researchers will track lung function, cough frequency and severity, breathlessness, quality of life, sleep quality, reflux symptoms, and hospital-free survival. Remote and in-person visits are possible, and participants will receive training on study procedures. The primary outcome is the change in lung function 12 months after starting treatment.
CONDITIONS
Brief Title
Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole
Research Team
E
Emily Harvey
T
TIPAL team
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Norfolk and Norwich University Hospitals NHS Foundation Trust
Lead Sponsor
Norwich Clinical Trials Unit
Collaborating Sponsor
Who Can Participate
Age: 40Years +
All Genders
Eligibility Criteria
You may qualify if you...
Male or female aged 40 years or older
Diagnosed with idiopathic pulmonary fibrosis (IPF) based on local or regional guidelines
May be receiving licensed anti-fibrotic medication for at least 4 weeks prior to randomisation with no planned changes for 4 weeks after
Able to give informed consent
For cough count sub-study: persistent troublesome cough for more than 8 weeks prior to enrolment
You will not qualify if you...
Unable to complete study assessments including reliable spirometry tests
Use of proton pump inhibitors or prokinetic drugs within 2 weeks before randomisation
Respiratory tract infection within 4 weeks before screening
Significant other respiratory diseases affecting symptoms or progression (except traction bronchiectasis)
FEV1/FVC ratio less than 0.7
Serious medical, surgical, or psychiatric conditions affecting safety or study results, including liver failure, advanced kidney disease, erosive oesophagitis, Barrett's oesophagus, or conditions needing lifelong PPI use
Allergy to proton pump inhibitors or placebo contents
Use of certain interacting medications (atazanavir, ketoconazole, itraconazole, tacrolimus, methotrexate, fluvoxamine)
Women who are of childbearing potential or breastfeeding
Participation in another investigational drug or biological trial within 4 weeks before enrolment or 5 times the drug half-life
Receiving long-term oxygen therapy
Low magnesium levels (hypomagnesemia) defined as magnesium ≤0.6 mmol/L
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (virtual or face-to-face) for informed consent, questionnaires, spirometry over 5 days at home, and blood sample for safety
Run-in Period
Duration - 2 weeks
Participants who are taking proton pump inhibitors (PPIs) without a clear clinical indication will undergo a 2 week wash-out period to assess whether they can safely stop this treatment before entering the study.
No required visits; monitoring occurs remotely during wash-out
Treatment
Duration - 12 months
Participants will take trial medication (Lansoprazole or matched placebo) twice daily for 12 months, with weekly at-home spirometry assessments and periodic questionnaires and blood samples to monitor safety and health status.
Weekly domiciliary spirometry assessments; 1 visit at 3 months, 1 visit at 6 months, 1 visit at 9 months, and 1 visit at 12 months post-randomisation (virtual or face-to-face) for questionnaires, blood samples, and medication adherence checks
Sub-study Assessments
Duration - At baseline and 3 months post-randomisation
Participants in the sub-study will complete two 24-hour cough frequency monitoring sessions and, if applicable, wear activity and sleep monitors, along with questionnaires on sleep habits.
2 monitoring periods of 24 hours each; questionnaires completed electronically or by post
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
The effectiveness and risks of Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole (TIPAL): study protocol for a randomised placebo-controlled multicentre clinical trial.