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RECRUITING

NCT04965298

PHASE3

Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole

Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

40 Years - Any

Study Type

INTERVENTIONAL

Enrollment

298

Start Date

2021-06-16

Completion Date

2026-02-28

Last Updated

2025-12-22

Healthy Volunteers

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

DRUG

Lansoprazole

Lansoprazole 30mg (as 2 x 15mg capsules) twice daily, 12 hours apart, for 12 months. IMP should be taken at least 30 minutes before food.

OTHER

Matched placebo

Matched placebo 2 capsules twice daily, 12 hours apart, for 12 months. Treatment should be taken at least 30 minutes before food.

Inclusion Criteria: 1. Male or female, aged greater than or equal to 40 years. 2. A diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on local or regional multi-disciplinary consensus according to the latest international guidelines (50). 3. Patients may be receiving licensed anti-fibrotic medication (for at least 4 weeks prior to randomisation with no planned amendments for at least 4 weeks post-randomisation). 4. Able to provide informed consent. Additional Inclusion Criteria for cough count sub-study: 1\. Pre-existing diagnosis of persistent cough (defined as troublesome for more than 8 weeks prior to study enrolment). Exclusion Criteria: 1. Patients unable to comply with study assessments including the ability to complete reliable spirometry assessments. 2. Concomitant use of a proton pump inhibitor (PPI) or prokinetic drugs (cisapride, domperidone, metoclopramide, erythromycin, prucalopride etc.) within 2 weeks prior to randomisation. 3. Patients with a self-reported respiratory tract infection within 4 weeks of screening (defined as two or more of: increased cough, sputum or breathlessness and requiring antimicrobial therapy). 4. Significant co-existing respiratory disease (defined as a respiratory condition that exhibits a clinically relevant effect on respiratory symptoms and disease progression as determined by the PI). The presence of traction bronchiectasis is permitted. 5. Patients with an FEV1/FVC\<0.7. 6. Significant medical, surgical or psychiatric disease that in the opinion of the patient's attending physician would affect subject safety or influence the study outcomes including liver failure (e.g. serum transaminase \> 2 x upper limit of normal (ULN), Bilirubin \> 1.5 x ULN (unless the patient has Gilbert's Syndrome) and chronic kidney disease (CKD) greater than stage 3 , erosive oesophagitis, Barrett's oesophagus or any condition requiring lifelong proton pump inhibitor use. 7. Known allergy to proton pump inhibitors or the contents of placebo. 8. Concomitant use of atazanavir, ketoconazole, itraconazole, tacrolimus, methotrexate, fluvoxamine (see section 6.4.5). 9. Females who are of childbearing potential or lactating. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A high FSH level in the postmenopausal range may be used to confirm a post-menopausal state in women not using hormonal contraception or hormonal replacement therapy. However in the absence of 12 months of amenorrhea, a single FSH measurement is insufficient. 10. Receipt of another investigational drug or biological agent associated with another clinical trial within the 4 weeks prior to TIPAL study enrolment or 5 times the drug half-life, whichever is the longer. 11. Receiving long-term oxygen therapy. 12. Patients with hypomagnesemia (defined as magnesium ≤0.6 mmol/L).

Locations (57)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, United Kingdom

NHS Grampian

Aberdeen, United Kingdom

Northern Health and Social Care Trust

Antrim, United Kingdom

Hampshire Hospitals NHS Foundation Trust

Basingstoke, United Kingdom

Royal United Hospitals Bath NHS Foundation Trust

Bath, United Kingdom

University Hospitals Birmingham NHS Foundation Trust (QEHB)

Birmingham, United Kingdom

University Hospitals Birmingham NHS Foundation Trust

Birmingham, United Kingdom

East Lancashire Hospitals NHS Trust

Blackburn, United Kingdom

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, United Kingdom

North Bristol NHS Trust

Bristol, United Kingdom

West Suffolk NHS Foundation Trust

Bury St Edmunds, United Kingdom

Royal Papworth Hospital NHS Foundation Trust

Cambridge, United Kingdom

Cardiff and Vale University Health Board

Cardiff, United Kingdom

Hywel Dda University Health Board

Carmarthen, United Kingdom

Southern Health & Social Care Trust

Craigavon, United Kingdom

Mid Cheshire Hospitals NHS Foundation Trust

Crewe, United Kingdom

Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster, United Kingdom

NHS Tayside

Dundee, United Kingdom

Royal Devon University Healthcare NHS Foundation Trust

Exeter, United Kingdom

Frimley Health NHS Foundation Trust

Frimley, United Kingdom

The Princess Alexandra Hospital NHS Trust

Harlow, United Kingdom

Calderdale and Huddersfield NHS Foundation Trust

Huddersfield, United Kingdom

Hull University Teaching Hospitals NHS Trust

Hull, United Kingdom

University Hospitals of Morecambe Bay NHS Foundation Trust

Kendal, United Kingdom

Leeds Teaching Hospitals NHS Trust

Leeds, United Kingdom

University Hospitals of Leicester NHS Trust

Leicester, United Kingdom

Liverpool University Hospitals NHS Foundation Trust

Liverpool, United Kingdom

Barts Health NHS Trust

London, United Kingdom

University College London Hospitals NHS Foundation Trust

London, United Kingdom

Lewisham and Greenwich NHS Trust

London, United Kingdom

Royal Brompton & Harefield NHS Foundation Trust

London, United Kingdom

Imperial College Healthcare NHS Trust

London, United Kingdom

Western Health and Social Care Trust

Londonderry, United Kingdom

Bedfordshire Hospitals NHS Foundation Trust

Luton, United Kingdom

East Cheshire NHS Trust

Macclesfield, United Kingdom

Manchester University NHS Foundation Trust

Manchester, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, United Kingdom

Northumbria Healthcare NHS Foundation Trust

North Shields, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Portsmouth Hospitals NHS Trust

Portsmouth, United Kingdom

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, United Kingdom

Shrewsbury and Telford Hospital NHS Trust

Shrewsbury, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

East and North Hertfordshire NHS Trust

Stevenage, United Kingdom

North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, United Kingdom

University Hospitals of North Midlands

Stoke-on-Trent, United Kingdom

South Tyneside And Sunderland NHS Foundation Trust

Sunderland, United Kingdom

Sherwood Forest Hospitals NHS Foundation Trust

Sutton in Ashfield, United Kingdom

Somerset NHS Foundation Trust

Taunton, United Kingdom

Kingston and Richmond NHS Foundation Trust

Teddington, United Kingdom

Torbay and South Devon NHS Foundation Trust

Torquay, United Kingdom

Wrightington, Wigan and Leigh NHS Foundation Trust

Wigan, United Kingdom

The Royal Wolverhampton NHS Trust

Wolverhampton, United Kingdom

Worcestershire Acute Hospitals NHS Trust

Worcester, United Kingdom

York and Scarborough Teaching Hospitals NHS Foundation Trust

York, United Kingdom

Clinical Research Directory

Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (57)