What is lansoprazole studying for idiopathic pulmonary fibrosis?

Lansoprazole is being studied to see if it can slow the progression of idiopathic pulmonary fibrosis (IPF) by reducing stomach acid that might harm the lungs. This trial aims to determine if adding lansoprazole to usual care helps IPF patients. The study is sponsored by Norfolk and Norwich University Hospitals NHS Foundation Trust and involves multiple UK hospitals.

Who may be eligible for this idiopathic pulmonary fibrosis clinical trial?

Adults aged 40 years or older with a confirmed diagnosis of idiopathic pulmonary fibrosis may be eligible. Both men and women can participate if they can perform home breathing tests and are not currently taking proton pump inhibitors or certain other medications. Please review eligibility criteria for more details.

Is there any cost to participate in this idiopathic pulmonary fibrosis clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered. Participants can expect some visits to be done remotely or in person depending on preference.

Actively Recruiting

Phase 3

Age: 40Years +

All Genders

ID04965298

The Effectiveness and Risks of Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole a Randomised Placebo-controlled Multi-centre Clinical Trial

Led by Norfolk and Norwich University Hospitals NHS Foundation Trust · Updated on 2025-12-22

298

Participants Needed

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

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

Research Team

Emily Harvey

TIPAL team

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