Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole

NCT04965298 | Recruiting Phase 3

• 4 other identifiers: 269050-80-06-192020-000041-14269050ISRCTN13526307
• Study Type: interventional
• Target: 298
• Locations: 1 country
• Sites: 57

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

Keywords

Idiopathic pulmonary fibrosis; IPF; Lansoprazole; Proton pump inhibitors; Cough; FVC; Forced vital capacity; Domiciliary spirometry; Virtual clinical trial

Outcome Measures

Primary Outcomes (1)

• Absolute change in percent predicted (%) forced vital capacity (FVC)

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

  12 months post-randomisation

Secondary Outcomes (16)

• Cough frequency

  3 months post-randomisation

• Cough score

  3, 6, 9 and 12 months post-randomisation

• Cough related

  3, 6, 9 and 12 months post-randomisation

• Breathlessness

  3, 6, 9 and 12 months post-randomisation

• Disease specific quality of life

  3, 6, 9 and 12 months post-randomisation

Study Arms (2)

Active treatment arm

EXPERIMENTAL

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.

Drug: Lansoprazole

Matched-Placebo arm

PLACEBO COMPARATOR

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

Other: Matched placebo

Interventions

Lansoprazole DRUG

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.

Active treatment arm

Matched placebo OTHER

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

Matched-Placebo arm

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• \. Pre-existing diagnosis of persistent cough (defined as troublesome for more than 8 weeks prior to study enrolment).

You may not qualify if:

• Patients unable to comply with study assessments including the ability to complete reliable spirometry assessments.
• Concomitant use of a proton pump inhibitor (PPI) or prokinetic drugs (cisapride, domperidone, metoclopramide, erythromycin, prucalopride etc.) within 2 weeks prior to randomisation.
• 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).
• 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.
• Patients with an FEV1/FVC\<0.7.
• 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.
• Known allergy to proton pump inhibitors or the contents of placebo.
• Concomitant use of atazanavir, ketoconazole, itraconazole, tacrolimus, methotrexate, fluvoxamine (see section 6.4.5).
• 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.
• 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.
• Receiving long-term oxygen therapy.
• Patients with hypomagnesemia (defined as magnesium ≤0.6 mmol/L).

Sponsors & Collaborators

• Norfolk and Norwich University Hospitals NHS Foundation Trust: lead
• Norwich Clinical Trials Unit: collaborator

Study Sites (57)

Norfolk and Norwich University Hospitals NHS Foundation Trust

Norwich, Norfolk, NR4 7UY, United Kingdom

RECRUITING

NHS Grampian

Aberdeen, AB15 6RE, United Kingdom

RECRUITING

Northern Health and Social Care Trust

Antrim, BT41 2RL, United Kingdom

RECRUITING

Hampshire Hospitals NHS Foundation Trust

Basingstoke, RG24 9NA, United Kingdom

COMPLETED

Royal United Hospitals Bath NHS Foundation Trust

Bath, BA1 3NG, United Kingdom

RECRUITING

University Hospitals Birmingham NHS Foundation Trust (QEHB)

Birmingham, B15 2GW, United Kingdom

RECRUITING

University Hospitals Birmingham NHS Foundation Trust

Birmingham, B15 2GW, United Kingdom

RECRUITING

East Lancashire Hospitals NHS Trust

Blackburn, BB2 3HH, United Kingdom

COMPLETED

Blackpool Teaching Hospitals NHS Foundation Trust

Blackpool, FY3 8NR, United Kingdom

NOT YET RECRUITING

North Bristol NHS Trust

Bristol, BS10 5NB, United Kingdom

COMPLETED

West Suffolk NHS Foundation Trust

Bury St Edmunds, IP33 2QZ, United Kingdom

RECRUITING

Royal Papworth Hospital NHS Foundation Trust

Cambridge, CB2 0AY, United Kingdom

RECRUITING

Cardiff and Vale University Health Board

Cardiff, CF14 4XW, United Kingdom

COMPLETED

Hywel Dda University Health Board

Carmarthen, SA31 3BB, United Kingdom

RECRUITING

Southern Health & Social Care Trust

Craigavon, BT63 5QQ, United Kingdom

COMPLETED

Mid Cheshire Hospitals NHS Foundation Trust

Crewe, CW1 4QJ, United Kingdom

COMPLETED

Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

Doncaster, DN2 5LT, United Kingdom

RECRUITING

NHS Tayside

Dundee, DD2 1UB, United Kingdom

RECRUITING

Royal Devon University Healthcare NHS Foundation Trust

Exeter, EX2 5DW, United Kingdom

RECRUITING

Frimley Health NHS Foundation Trust

Frimley, GU16 7UJ, United Kingdom

COMPLETED

The Princess Alexandra Hospital NHS Trust

Harlow, CM20 1QX, United Kingdom

RECRUITING

Calderdale and Huddersfield NHS Foundation Trust

Huddersfield, HD3 3EA, United Kingdom

COMPLETED

Hull University Teaching Hospitals NHS Trust

Hull, HU3 2JZ, United Kingdom

RECRUITING

University Hospitals of Morecambe Bay NHS Foundation Trust

Kendal, LA9 7RG, United Kingdom

RECRUITING

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7TF, United Kingdom

RECRUITING

University Hospitals of Leicester NHS Trust

Leicester, LE1 5WW, United Kingdom

RECRUITING

Liverpool University Hospitals NHS Foundation Trust

Liverpool, L7 8XP, United Kingdom

RECRUITING

Barts Health NHS Trust

London, E1 2ES, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW1 2PG, United Kingdom

RECRUITING

Lewisham and Greenwich NHS Trust

London, SE13 6LH, United Kingdom

RECRUITING

Royal Brompton & Harefield NHS Foundation Trust

London, SW3 6PY, United Kingdom

RECRUITING

Imperial College Healthcare NHS Trust

London, W2 1NY, United Kingdom

RECRUITING

Western Health and Social Care Trust

Londonderry, BT47 6SB, United Kingdom

RECRUITING

Bedfordshire Hospitals NHS Foundation Trust

Luton, LU4 0DZ, United Kingdom

COMPLETED

East Cheshire NHS Trust

Macclesfield, SK10 3BL, United Kingdom

COMPLETED

Manchester University NHS Foundation Trust

Manchester, M13 9WL, United Kingdom

RECRUITING

The Newcastle upon Tyne Hospitals NHS Foundation Trust

Newcastle upon Tyne, NE7 7DN, United Kingdom

RECRUITING

Northumbria Healthcare NHS Foundation Trust

North Shields, NE29 8NH, United Kingdom

RECRUITING

Nottingham University Hospitals NHS Trust

Nottingham, NG5 1PB, United Kingdom

COMPLETED

Oxford University Hospitals NHS Foundation Trust

Oxford, OX3 9DU, United Kingdom

COMPLETED

Portsmouth Hospitals NHS Trust

Portsmouth, PO6 3LY, United Kingdom

COMPLETED

Lancashire Teaching Hospitals NHS Foundation Trust

Preston, PR2 9HT, United Kingdom

COMPLETED

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, S10 2JF, United Kingdom

COMPLETED

Shrewsbury and Telford Hospital NHS Trust

Shrewsbury, SY3 8XQ, United Kingdom

RECRUITING

University Hospital Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

RECRUITING

East and North Hertfordshire NHS Trust

Stevenage, SG1 4AB, United Kingdom

RECRUITING

North Tees and Hartlepool NHS Foundation Trust

Stockton-on-Tees, TS19 8PE, United Kingdom

RECRUITING

University Hospitals of North Midlands

Stoke-on-Trent, ST4 6QG, United Kingdom

RECRUITING

South Tyneside And Sunderland NHS Foundation Trust

Sunderland, SR4 7TP, United Kingdom

RECRUITING

Sherwood Forest Hospitals NHS Foundation Trust

Sutton in Ashfield, NG17 4JL, United Kingdom

RECRUITING

Somerset NHS Foundation Trust

Taunton, TA1 5DA, United Kingdom

RECRUITING

Kingston and Richmond NHS Foundation Trust

Teddington, TW11 8HU, United Kingdom

RECRUITING

Torbay and South Devon NHS Foundation Trust

Torquay, TQ2 7AA, United Kingdom

RECRUITING

Wrightington, Wigan and Leigh NHS Foundation Trust

Wigan, WN1 2NN, United Kingdom

RECRUITING

The Royal Wolverhampton NHS Trust

Wolverhampton, WV10 0QP, United Kingdom

RECRUITING

Worcestershire Acute Hospitals NHS Trust

Worcester, WR5 1DD, United Kingdom

RECRUITING

York and Scarborough Teaching Hospitals NHS Foundation Trust

York, YO31 8HE, United Kingdom

RECRUITING

Related Publications (1)

• Jones M, Cahn A, Chaudhuri N, Clark AB, Forrest I, Hammond M, Jones S, Maher TM, Parfrey H, Raghu G, Simpson AJ, Smith JA, Spencer LG, Thickett D, Vale L, Wahed S, Ward C, Wilson AM. The effectiveness and risks of Treating people with Idiopathic Pulmonary fibrosis with the Addition of Lansoprazole (TIPAL): study protocol for a randomised placebo-controlled multicentre clinical trial. BMJ Open. 2025 Feb 5;15(2):e088604. doi: 10.1136/bmjopen-2024-088604.

  PMID: 39909521 DERIVED

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Cough

Interventions

Lansoprazole

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Professor Andrew Wilson

  Norfolk and Norwich University Hospitals NHS Foundation Trust

  STUDY CHAIR

Central Study Contacts

Emily Harvey

CONTACT

01603 591224; emily.harvey@uea.ac.uk

TIPAL team

CONTACT

tipal@uea.ac.uk

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participant, care provider, investigator, outcomes assessor. Statistician. Double-blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2021
• First Posted: July 16, 2021
• Study Start: June 16, 2021
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

GB (57)