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Could a common heartburn drug be the key to slowing a deadly lung disease?

NCT ID NCT04965298

Disease control Sponsor: Norfolk and Norwich University Hospitals NHS Foundation Trust Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether lansoprazole, a medicine that reduces stomach acid, can slow the progression of idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and breathing problems. About 298 adults with IPF will take either lansoprazole or a placebo twice daily for 12 months. Researchers will measure changes in lung function, cough, and quality of life to see if the drug helps.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 298 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2021

Expected to finish

Feb 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Cough idiopathic pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    42 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Barts Health NHS Trust

    RECRUITING

    London, E1 2ES, United Kingdom

  • Bedfordshire Hospitals NHS Foundation Trust

    COMPLETED

    Luton, LU4 0DZ, United Kingdom

  • Blackpool Teaching Hospitals NHS Foundation Trust

    NOT_YET_RECRUITING

    Blackpool, FY3 8NR, United Kingdom

  • Calderdale and Huddersfield NHS Foundation Trust

    COMPLETED

    Huddersfield, HD3 3EA, United Kingdom

  • Cardiff and Vale University Health Board

    COMPLETED

    Cardiff, CF14 4XW, United Kingdom

  • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust

    RECRUITING

    Doncaster, DN2 5LT, United Kingdom

  • East Cheshire NHS Trust

    COMPLETED

    Macclesfield, SK10 3BL, United Kingdom

  • East Lancashire Hospitals NHS Trust

    COMPLETED

    Blackburn, BB2 3HH, United Kingdom

  • East and North Hertfordshire NHS Trust

    RECRUITING

    Stevenage, SG1 4AB, United Kingdom

  • Frimley Health NHS Foundation Trust

    COMPLETED

    Frimley, GU16 7UJ, United Kingdom

  • Hampshire Hospitals NHS Foundation Trust

    COMPLETED

    Basingstoke, RG24 9NA, United Kingdom

  • Hull University Teaching Hospitals NHS Trust

    RECRUITING

    Hull, HU3 2JZ, United Kingdom

  • Hywel Dda University Health Board

    RECRUITING

    Carmarthen, SA31 3BB, United Kingdom

  • Imperial College Healthcare NHS Trust

    RECRUITING

    London, W2 1NY, United Kingdom

  • Kingston and Richmond NHS Foundation Trust

    RECRUITING

    Teddington, TW11 8HU, United Kingdom

  • Lancashire Teaching Hospitals NHS Foundation Trust

    COMPLETED

    Preston, PR2 9HT, United Kingdom

  • Leeds Teaching Hospitals NHS Trust

    RECRUITING

    Leeds, LS9 7TF, United Kingdom

  • Lewisham and Greenwich NHS Trust

    RECRUITING

    London, SE13 6LH, United Kingdom

  • Liverpool University Hospitals NHS Foundation Trust

    RECRUITING

    Liverpool, L7 8XP, United Kingdom

  • Manchester University NHS Foundation Trust

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Mid Cheshire Hospitals NHS Foundation Trust

    COMPLETED

    Crewe, CW1 4QJ, United Kingdom

  • NHS Grampian

    RECRUITING

    Aberdeen, AB15 6RE, United Kingdom

  • NHS Tayside

    RECRUITING

    Dundee, DD2 1UB, United Kingdom

  • Norfolk and Norwich University Hospitals NHS Foundation Trust

    RECRUITING

    Norwich, Norfolk, NR4 7UY, United Kingdom

  • North Bristol NHS Trust

    COMPLETED

    Bristol, BS10 5NB, United Kingdom

  • North Tees and Hartlepool NHS Foundation Trust

    RECRUITING

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

  • Northern Health and Social Care Trust

    RECRUITING

    Antrim, BT41 2RL, United Kingdom

  • Northumbria Healthcare NHS Foundation Trust

    RECRUITING

    North Shields, NE29 8NH, United Kingdom

  • Nottingham University Hospitals NHS Trust

    COMPLETED

    Nottingham, NG5 1PB, United Kingdom

  • Oxford University Hospitals NHS Foundation Trust

    COMPLETED

    Oxford, OX3 9DU, United Kingdom

  • Portsmouth Hospitals NHS Trust

    COMPLETED

    Portsmouth, PO6 3LY, United Kingdom

  • Royal Brompton & Harefield NHS Foundation Trust

    RECRUITING

    London, SW3 6PY, United Kingdom

  • Royal Devon University Healthcare NHS Foundation Trust

    RECRUITING

    Exeter, EX2 5DW, United Kingdom

  • Royal Papworth Hospital NHS Foundation Trust

    RECRUITING

    Cambridge, CB2 0AY, United Kingdom

  • Royal United Hospitals Bath NHS Foundation Trust

    RECRUITING

    Bath, BA1 3NG, United Kingdom

  • Sheffield Teaching Hospitals NHS Foundation Trust

    COMPLETED

    Sheffield, S10 2JF, United Kingdom

  • Sherwood Forest Hospitals NHS Foundation Trust

    RECRUITING

    Sutton in Ashfield, NG17 4JL, United Kingdom

  • Shrewsbury and Telford Hospital NHS Trust

    RECRUITING

    Shrewsbury, SY3 8XQ, United Kingdom

  • Somerset NHS Foundation Trust

    RECRUITING

    Taunton, TA1 5DA, United Kingdom

  • South Tyneside And Sunderland NHS Foundation Trust

    RECRUITING

    Sunderland, SR4 7TP, United Kingdom

  • Southern Health & Social Care Trust

    COMPLETED

    Craigavon, BT63 5QQ, United Kingdom

  • The Newcastle upon Tyne Hospitals NHS Foundation Trust

    RECRUITING

    Newcastle upon Tyne, NE7 7DN, United Kingdom

  • The Princess Alexandra Hospital NHS Trust

    RECRUITING

    Harlow, CM20 1QX, United Kingdom

  • The Royal Wolverhampton NHS Trust

    RECRUITING

    Wolverhampton, WV10 0QP, United Kingdom

  • Torbay and South Devon NHS Foundation Trust

    RECRUITING

    Torquay, TQ2 7AA, United Kingdom

  • University College London Hospitals NHS Foundation Trust

    RECRUITING

    London, NW1 2PG, United Kingdom

  • University Hospital Southampton NHS Foundation Trust

    RECRUITING

    Southampton, SO16 6YD, United Kingdom

  • University Hospitals Birmingham NHS Foundation Trust

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • University Hospitals Birmingham NHS Foundation Trust (QEHB)

    RECRUITING

    Birmingham, B15 2GW, United Kingdom

  • University Hospitals of Leicester NHS Trust

    RECRUITING

    Leicester, LE1 5WW, United Kingdom

  • University Hospitals of Morecambe Bay NHS Foundation Trust

    RECRUITING

    Kendal, LA9 7RG, United Kingdom

  • University Hospitals of North Midlands

    RECRUITING

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

  • West Suffolk NHS Foundation Trust

    RECRUITING

    Bury St Edmunds, IP33 2QZ, United Kingdom

  • Western Health and Social Care Trust

    RECRUITING

    Londonderry, BT47 6SB, United Kingdom

  • Worcestershire Acute Hospitals NHS Trust

    RECRUITING

    Worcester, WR5 1DD, United Kingdom

  • Wrightington, Wigan and Leigh NHS Foundation Trust

    RECRUITING

    Wigan, WN1 2NN, United Kingdom

  • York and Scarborough Teaching Hospitals NHS Foundation Trust

    RECRUITING

    York, YO31 8HE, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.