Actively Recruiting
Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole
Led by Norfolk and Norwich University Hospitals NHS Foundation Trust · Updated on 2025-12-22
298
Participants Needed
57
Research Sites
245 weeks
Total Duration
On this page
Sponsors
N
Norfolk and Norwich University Hospitals NHS Foundation Trust
Lead Sponsor
N
Norwich Clinical Trials Unit
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 40 years or older
- Diagnosis of idiopathic pulmonary fibrosis (IPF) based on local or regional expert consensus
- If receiving anti-fibrotic medication, treatment must have started at least 4 weeks before randomization with no planned changes for 4 weeks after
- Able to provide informed consent
- For cough count sub-study: persistent troublesome cough lasting more than 8 weeks before enrollment
You will not qualify if you...
- Unable to complete study assessments such as reliable spirometry tests
- Use of proton pump inhibitors or prokinetic drugs within 2 weeks before randomization
- 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, chronic kidney disease stage greater than 3, erosive oesophagitis, Barrett's oesophagus, or ongoing need for proton pump inhibitors
- Known allergy to proton pump inhibitors or placebo contents
- Use of certain interacting medications (atazanavir, ketoconazole, itraconazole, tacrolimus, methotrexate, fluvoxamine)
- Women of childbearing potential or breastfeeding
- Participation in another investigational drug or biological agent trial within 4 weeks or 5 times the drug half-life
- Receiving long-term oxygen therapy
- Low magnesium levels (≤ 0.6 mmol/L)
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Trial Site Locations
Total: 57 locations
1
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
Actively Recruiting
2
NHS Grampian
Aberdeen, United Kingdom, AB15 6RE
Actively Recruiting
3
Northern Health and Social Care Trust
Antrim, United Kingdom, BT41 2RL
Actively Recruiting
4
Hampshire Hospitals NHS Foundation Trust
Basingstoke, United Kingdom, RG24 9NA
Completed
5
Royal United Hospitals Bath NHS Foundation Trust
Bath, United Kingdom, BA1 3NG
Actively Recruiting
6
University Hospitals Birmingham NHS Foundation Trust (QEHB)
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
7
University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom, B15 2GW
Actively Recruiting
8
East Lancashire Hospitals NHS Trust
Blackburn, United Kingdom, BB2 3HH
Completed
9
Blackpool Teaching Hospitals NHS Foundation Trust
Blackpool, United Kingdom, FY3 8NR
Not Yet Recruiting
10
North Bristol NHS Trust
Bristol, United Kingdom, BS10 5NB
Completed
11
West Suffolk NHS Foundation Trust
Bury St Edmunds, United Kingdom, IP33 2QZ
Actively Recruiting
12
Royal Papworth Hospital NHS Foundation Trust
Cambridge, United Kingdom, CB2 0AY
Actively Recruiting
13
Cardiff and Vale University Health Board
Cardiff, United Kingdom, CF14 4XW
Completed
14
Hywel Dda University Health Board
Carmarthen, United Kingdom, SA31 3BB
Actively Recruiting
15
Southern Health & Social Care Trust
Craigavon, United Kingdom, BT63 5QQ
Completed
16
Mid Cheshire Hospitals NHS Foundation Trust
Crewe, United Kingdom, CW1 4QJ
Completed
17
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, United Kingdom, DN2 5LT
Actively Recruiting
18
NHS Tayside
Dundee, United Kingdom, DD2 1UB
Actively Recruiting
19
Royal Devon University Healthcare NHS Foundation Trust
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
20
Frimley Health NHS Foundation Trust
Frimley, United Kingdom, GU16 7UJ
Completed
21
The Princess Alexandra Hospital NHS Trust
Harlow, United Kingdom, CM20 1QX
Actively Recruiting
22
Calderdale and Huddersfield NHS Foundation Trust
Huddersfield, United Kingdom, HD3 3EA
Completed
23
Hull University Teaching Hospitals NHS Trust
Hull, United Kingdom, HU3 2JZ
Actively Recruiting
24
University Hospitals of Morecambe Bay NHS Foundation Trust
Kendal, United Kingdom, LA9 7RG
Actively Recruiting
25
Leeds Teaching Hospitals NHS Trust
Leeds, United Kingdom, LS9 7TF
Actively Recruiting
26
University Hospitals of Leicester NHS Trust
Leicester, United Kingdom, LE1 5WW
Actively Recruiting
27
Liverpool University Hospitals NHS Foundation Trust
Liverpool, United Kingdom, L7 8XP
Actively Recruiting
28
Barts Health NHS Trust
London, United Kingdom, E1 2ES
Actively Recruiting
29
University College London Hospitals NHS Foundation Trust
London, United Kingdom, NW1 2PG
Actively Recruiting
30
Lewisham and Greenwich NHS Trust
London, United Kingdom, SE13 6LH
Actively Recruiting
31
Royal Brompton & Harefield NHS Foundation Trust
London, United Kingdom, SW3 6PY
Actively Recruiting
32
Imperial College Healthcare NHS Trust
London, United Kingdom, W2 1NY
Actively Recruiting
33
Western Health and Social Care Trust
Londonderry, United Kingdom, BT47 6SB
Actively Recruiting
34
Bedfordshire Hospitals NHS Foundation Trust
Luton, United Kingdom, LU4 0DZ
Completed
35
East Cheshire NHS Trust
Macclesfield, United Kingdom, SK10 3BL
Completed
36
Manchester University NHS Foundation Trust
Manchester, United Kingdom, M13 9WL
Actively Recruiting
37
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom, NE7 7DN
Actively Recruiting
38
Northumbria Healthcare NHS Foundation Trust
North Shields, United Kingdom, NE29 8NH
Actively Recruiting
39
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom, NG5 1PB
Completed
40
Oxford University Hospitals NHS Foundation Trust
Oxford, United Kingdom, OX3 9DU
Completed
41
Portsmouth Hospitals NHS Trust
Portsmouth, United Kingdom, PO6 3LY
Completed
42
Lancashire Teaching Hospitals NHS Foundation Trust
Preston, United Kingdom, PR2 9HT
Completed
43
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, United Kingdom, S10 2JF
Completed
44
Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, United Kingdom, SY3 8XQ
Actively Recruiting
45
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom, SO16 6YD
Actively Recruiting
46
East and North Hertfordshire NHS Trust
Stevenage, United Kingdom, SG1 4AB
Actively Recruiting
47
North Tees and Hartlepool NHS Foundation Trust
Stockton-on-Tees, United Kingdom, TS19 8PE
Actively Recruiting
48
University Hospitals of North Midlands
Stoke-on-Trent, United Kingdom, ST4 6QG
Actively Recruiting
49
South Tyneside And Sunderland NHS Foundation Trust
Sunderland, United Kingdom, SR4 7TP
Actively Recruiting
50
Sherwood Forest Hospitals NHS Foundation Trust
Sutton in Ashfield, United Kingdom, NG17 4JL
Actively Recruiting
51
Somerset NHS Foundation Trust
Taunton, United Kingdom, TA1 5DA
Actively Recruiting
52
Kingston and Richmond NHS Foundation Trust
Teddington, United Kingdom, TW11 8HU
Actively Recruiting
53
Torbay and South Devon NHS Foundation Trust
Torquay, United Kingdom, TQ2 7AA
Actively Recruiting
54
Wrightington, Wigan and Leigh NHS Foundation Trust
Wigan, United Kingdom, WN1 2NN
Actively Recruiting
55
The Royal Wolverhampton NHS Trust
Wolverhampton, United Kingdom, WV10 0QP
Actively Recruiting
56
Worcestershire Acute Hospitals NHS Trust
Worcester, United Kingdom, WR5 1DD
Actively Recruiting
57
York and Scarborough Teaching Hospitals NHS Foundation Trust
York, United Kingdom, YO31 8HE
Actively Recruiting
Research Team
E
Emily Harvey
CONTACT
T
TIPAL team
CONTACT
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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