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

Who is this study for? Patients with idiopathic pulmonary fibrosis
What treatments are being studied? Lansoprazole
Status: Recruiting
Location: See all (57) locations...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Healthy Volunteers: f
View:

• Male or female, aged greater than or equal to 40 years.

• A diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based on local or regional multi-disciplinary consensus according to the latest international guidelines (50).

• 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).

• 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).

Locations
Other Locations
United Kingdom
NHS Grampian
RECRUITING
Aberdeen
Northern Health and Social Care Trust
RECRUITING
Antrim
Hampshire Hospitals NHS Foundation Trust
COMPLETED
Basingstoke
Royal United Hospitals Bath NHS Foundation Trust
RECRUITING
Bath
University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
University Hospitals Birmingham NHS Foundation Trust (QEHB)
RECRUITING
Birmingham
East Lancashire Hospitals NHS Trust
COMPLETED
Blackburn
Blackpool Teaching Hospitals NHS Foundation Trust
NOT_YET_RECRUITING
Blackpool
North Bristol NHS Trust
COMPLETED
Bristol
West Suffolk NHS Foundation Trust
RECRUITING
Bury St Edmunds
Royal Papworth Hospital NHS Foundation Trust
RECRUITING
Cambridge
Cardiff and Vale University Health Board
COMPLETED
Cardiff
Hywel Dda University Health Board
RECRUITING
Carmarthen
Southern Health & Social Care Trust
COMPLETED
Craigavon
Mid Cheshire Hospitals NHS Foundation Trust
COMPLETED
Crewe
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
RECRUITING
Doncaster
NHS Tayside
RECRUITING
Dundee
Royal Devon University Healthcare NHS Foundation Trust
RECRUITING
Exeter
Frimley Health NHS Foundation Trust
COMPLETED
Frimley
The Princess Alexandra Hospital NHS Trust
RECRUITING
Harlow
Calderdale and Huddersfield NHS Foundation Trust
COMPLETED
Huddersfield
Hull University Teaching Hospitals NHS Trust
RECRUITING
Hull
University Hospitals of Morecambe Bay NHS Foundation Trust
RECRUITING
Kendal
Leeds Teaching Hospitals NHS Trust
RECRUITING
Leeds
University Hospitals of Leicester NHS Trust
RECRUITING
Leicester
Liverpool University Hospitals NHS Foundation Trust
RECRUITING
Liverpool
Barts Health NHS Trust
RECRUITING
London
Imperial College Healthcare NHS Trust
RECRUITING
London
Lewisham and Greenwich NHS Trust
RECRUITING
London
Royal Brompton & Harefield NHS Foundation Trust
RECRUITING
London
University College London Hospitals NHS Foundation Trust
RECRUITING
London
Western Health and Social Care Trust
RECRUITING
Londonderry
Bedfordshire Hospitals NHS Foundation Trust
COMPLETED
Luton
East Cheshire NHS Trust
COMPLETED
Macclesfield
Manchester University NHS Foundation Trust
RECRUITING
Manchester
The Newcastle upon Tyne Hospitals NHS Foundation Trust
RECRUITING
Newcastle Upon Tyne
Northumbria Healthcare NHS Foundation Trust
RECRUITING
North Shields
Norfolk and Norwich University Hospitals NHS Foundation Trust
RECRUITING
Norwich
Nottingham University Hospitals NHS Trust
COMPLETED
Nottingham
Oxford University Hospitals NHS Foundation Trust
COMPLETED
Oxford
Portsmouth Hospitals NHS Trust
COMPLETED
Portsmouth
Lancashire Teaching Hospitals NHS Foundation Trust
COMPLETED
Preston
Sheffield Teaching Hospitals NHS Foundation Trust
COMPLETED
Sheffield
Shrewsbury and Telford Hospital NHS Trust
RECRUITING
Shrewsbury
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
East and North Hertfordshire NHS Trust
RECRUITING
Stevenage
North Tees and Hartlepool NHS Foundation Trust
RECRUITING
Stockton-on-tees
University Hospitals of North Midlands
RECRUITING
Stoke-on-trent
South Tyneside And Sunderland NHS Foundation Trust
RECRUITING
Sunderland
Sherwood Forest Hospitals NHS Foundation Trust
RECRUITING
Sutton In Ashfield
Somerset NHS Foundation Trust
RECRUITING
Taunton
Kingston and Richmond NHS Foundation Trust
RECRUITING
Teddington
Torbay and South Devon NHS Foundation Trust
RECRUITING
Torquay
Wrightington, Wigan and Leigh NHS Foundation Trust
RECRUITING
Wigan
The Royal Wolverhampton NHS Trust
RECRUITING
Wolverhampton
Worcestershire Acute Hospitals NHS Trust
RECRUITING
Worcester
York and Scarborough Teaching Hospitals NHS Foundation Trust
RECRUITING
York
Contact Information
Primary
Emily Harvey
emily.harvey@uea.ac.uk
01603 591224
Backup
TIPAL team
tipal@uea.ac.uk
Time Frame
Start Date: 2021-06-16
Estimated Completion Date: 2026-02-28
Participants
Target number of participants: 298
Treatments
Experimental: Active treatment arm
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.
Placebo_comparator: Matched-Placebo arm
Matched placebo 2 capsules twice daily, 12 hours apart, for 12 months. Treatment should be taken at least 30 minutes before food.
Sponsors
Leads: Norfolk and Norwich University Hospitals NHS Foundation Trust
Collaborators: Norwich Clinical Trials Unit

This content was sourced from clinicaltrials.gov