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Studies

Interventional Recruiting Phase 3

NCT04965298 on ClinicalTrials.gov

Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole

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

  • Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust
  • Collaborators: Norwich Clinical Trials Unit
  • Enrollment: 298 (Estimated)
  • Study start: 2021-06-16 (Actual)
  • Primary completion: 2026-02-28 (Estimated)
  • Study completion: 2026-02-28 (Estimated)
  • Allocation: Randomized
  • InterventionModel: Parallel
  • InterventionModelDescription: This study is an interventional clinical trial of an investigational medicinal product: a phase III, randomised, placebo-controlled, two arm parallel group, double-blind, multicentre clinical trial. Randomisation will be generated by a secure web-based system on a 1:1 basis with minimisation for recruiting site, baseline IPF treatment, reflux and cough. All study visits may be conducted remotely without the need for participants to attend the participating site.
  • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • PrimaryPurpose: Treatment

Brief 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.

Conditions

  • Idiopathic Pulmonary Fibrosis

Intervention / Treatment

  • Drug: Lansoprazole
  • Other: Matched placebo

Primary Outcome Measures

  • Absolute change in percent predicted (%) forced vital capacity (FVC) (12 months post-randomisation)
    Absolute change in percent predicted (%) forced vital capacity (FVC) at 12 months post-randomisation of lansoprazole versus placebo.

Countries

United Kingdom

Locations and Investigators

  • Norfolk and Norwich University Hospitals NHS Foundation Trust, Norwich, United Kingdom (Recruiting)
    • Andrew Wilson
    • Andrew Wilson (Principal Investigator)
  • NHS Grampian, Aberdeen, United Kingdom (Recruiting)
    • Owen Dempsey
    • Owen Dempsey (Principal Investigator)
  • Northern Health and Social Care Trust, Antrim, United Kingdom (Recruiting)
    • Paul Minnis
    • Paul Minnis (Principal Investigator)
  • Hampshire Hospitals NHS Foundation Trust, Basingstoke, United Kingdom (Completed)
  • Royal United Hospitals Bath NHS Foundation Trust, Bath, United Kingdom (Recruiting)
    • Tom Hartley
    • Tom Hartley (Principal Investigator)
  • University Hospitals Birmingham NHS Foundation Trust (QEHB), Birmingham, United Kingdom (Recruiting)
    • David Thickett
    • David Thickett (Principal Investigator)
  • University Hospitals Birmingham NHS Foundation Trust, Birmingham, United Kingdom (Recruiting)
    • Gareth Walters
    • Gareth Walters (Principal Investigator)
  • East Lancashire Hospitals NHS Trust, Blackburn, United Kingdom (Completed)
  • Blackpool Teaching Hospitals NHS Foundation Trust, Blackpool, United Kingdom (Not yet recruiting)
    • Thomas Bongers
    • Thomas Bongers (Principal Investigator)
  • North Bristol NHS Trust, Bristol, United Kingdom (Completed)
  • West Suffolk NHS Foundation Trust, Bury St Edmunds, United Kingdom (Recruiting)
    • Ludmila Shulgina
    • Ludmila Shulgina (Principal Investigator)
  • Royal Papworth Hospital NHS Foundation Trust, Cambridge, United Kingdom (Recruiting)
    • Helen Parfrey
    • Helen Parfrey (Principal Investigator)
  • Cardiff and Vale University Health Board, Cardiff, United Kingdom (Completed)
  • Hywel Dda University Health Board, Carmarthen, United Kingdom (Recruiting)
    • Mark Andrews
    • Mark Andrews (Principal Investigator)
  • Southern Health & Social Care Trust, Craigavon, United Kingdom (Completed)
  • Mid Cheshire Hospitals NHS Foundation Trust, Crewe, United Kingdom (Completed)
  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust, Doncaster, United Kingdom (Recruiting)
    • Alisa Holbourn
    • Alisa Holbourn (Principal Investigator)
  • NHS Tayside, Dundee, United Kingdom (Recruiting)
    • Andrew Goudie
    • Andrew Goudie (Principal Investigator)
  • Royal Devon University Healthcare NHS Foundation Trust, Exeter, United Kingdom (Recruiting)
    • Stefan Stanel
    • Stefan Stanel (Principal Investigator)
  • Frimley Health NHS Foundation Trust, Frimley, United Kingdom (Completed)
  • The Princess Alexandra Hospital NHS Trust, Harlow, United Kingdom (Recruiting)
    • Muhammed Anward
    • Muhammed Anward (Principal Investigator)
  • Calderdale and Huddersfield NHS Foundation Trust, Huddersfield, United Kingdom (Completed)
  • Hull University Teaching Hospitals NHS Trust, Hull, United Kingdom (Recruiting)
    • Simon Hart
    • Simon Hart (Principal Investigator)
  • University Hospitals of Morecambe Bay NHS Foundation Trust, Kendal, United Kingdom (Recruiting)
    • Timothy Gatheral
    • Timothy Gatheral (Principal Investigator)
  • Leeds Teaching Hospitals NHS Trust, Leeds, United Kingdom (Recruiting)
    • Paul Beirne
    • Paul Beirne (Principal Investigator)
  • University Hospitals of Leicester NHS Trust, Leicester, United Kingdom (Recruiting)
    • Fasihul Khan
    • Fasihul Khan (Principal Investigator)
  • Liverpool University Hospitals NHS Foundation Trust, Liverpool, United Kingdom (Recruiting)
  • Barts Health NHS Trust, London, United Kingdom (Recruiting)
    • Richard Tosner
    • Richard Tosner (Principal Investigator)
  • University College London Hospitals NHS Foundation Trust, London, United Kingdom (Recruiting)
    • Joanna Porter
    • Joanna Porter (Principal Investigator)
  • Lewisham and Greenwich NHS Trust, London, United Kingdom (Recruiting)
    • Tom Simpson
    • Tom Simpson (Principal Investigator)
  • Royal Brompton & Harefield NHS Foundation Trust, London, United Kingdom (Recruiting)
    • Philip Molyneaux
    • Philip Molyneaux (Principal Investigator)
  • Imperial College Healthcare NHS Trust, London, United Kingdom (Recruiting)
    • Robina Coker
    • Robina Coker (Principal Investigator)
  • Western Health and Social Care Trust, Londonderry, United Kingdom (Recruiting)
    • Martin Kelly
    • Martin Kelly (Principal Investigator)
  • Bedfordshire Hospitals NHS Foundation Trust, Luton, United Kingdom (Completed)
  • East Cheshire NHS Trust, Macclesfield, United Kingdom (Completed)
  • Manchester University NHS Foundation Trust, Manchester, United Kingdom (Recruiting)
    • Dr Conal Hayton
    • Conal Hayton (Principal Investigator)
  • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, United Kingdom (Recruiting)
    • Ian Forrest
    • Ian Forrest (Principal Investigator)
  • Northumbria Healthcare NHS Foundation Trust, North Shields, United Kingdom (Recruiting)
    • Laura Mackay
    • Laura Mackay (Principal Investigator)
  • Nottingham University Hospitals NHS Trust, Nottingham, United Kingdom (Completed)
  • Oxford University Hospitals NHS Foundation Trust, Oxford, United Kingdom (Completed)
  • Portsmouth Hospitals NHS Trust, Portsmouth, United Kingdom (Completed)
  • Lancashire Teaching Hospitals NHS Foundation Trust, Preston, United Kingdom (Completed)
  • Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, United Kingdom (Completed)
  • Shrewsbury and Telford Hospital NHS Trust, Shrewsbury, United Kingdom (Recruiting)
    • Richard Heinick
    • Richard Heinick (Principal Investigator)
  • University Hospital Southampton NHS Foundation Trust, Southampton, United Kingdom (Recruiting)
    • Sophie Fletcher
    • Sophie Fletcher (Principal Investigator)
  • East and North Hertfordshire NHS Trust, Stevenage, United Kingdom (Recruiting)
    • Ritesh Kumar
    • Ritesh Kumar (Principal Investigator)
  • North Tees and Hartlepool NHS Foundation Trust, Stockton-on-Tees, United Kingdom (Recruiting)
    • Graham Miller
    • Graham Miller (Principal Investigator)
  • University Hospitals of North Midlands, Stoke-on-Trent, United Kingdom (Recruiting)
    • Helen Stone
    • Helen Stone (Principal Investigator)
  • South Tyneside And Sunderland NHS Foundation Trust, Sunderland, United Kingdom (Recruiting)
    • Andrew Macnair
    • Andrew Macnair (Principal Investigator)
  • Sherwood Forest Hospitals NHS Foundation Trust, Sutton in Ashfield, United Kingdom (Recruiting)
    • Khaled Amsha
    • Khaled Amsha (Principal Investigator)

And 7 other sites.

Study Officials