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Using Lansoprazole to Treat Idiopathic Pulmonary Fibrosis

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

Phase 3 Interventional Norfolk and Norwich University Hospitals NHS Foundation Trust · NCT04965298

This study is testing if adding Lansoprazole can help people with Idiopathic Pulmonary Fibrosis breathe better and slow down the disease.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment298 (estimated)
Ages40 Years and up
SexAll
SponsorNorfolk and Norwich University Hospitals NHS Foundation Trust Academic / other
Drugs / interventionsmethotrexate
Locations57 sites (Norwich, Norfolk and 56 other locations)
Trial IDNCT04965298 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates whether the addition of Lansoprazole, a proton pump inhibitor, can slow the progression of Idiopathic Pulmonary Fibrosis (IPF) in patients. The study will involve 298 participants from approximately 37 hospitals in the UK, who will perform weekly breathing tests and monitor their cough frequency. Patients will be randomly assigned to receive either Lansoprazole or a placebo, and their symptoms will be assessed through questionnaires and monitoring devices. The goal is to determine if Lansoprazole can improve outcomes for IPF patients by reducing reflux symptoms and potentially slowing disease progression.

Who should consider this trial

Good fit: Ideal candidates are adults aged 40 and older with a confirmed diagnosis of Idiopathic Pulmonary Fibrosis.

Not a fit: Patients currently using proton pump inhibitors or those unable to comply with study assessments may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide IPF patients with a new option to slow disease progression and improve their quality of life.

How similar studies have performed: While there have been no specific studies directly investigating this approach, previous research suggests potential benefits of proton pump inhibitors in IPF management.

Eligibility criteria

Show full inclusion / exclusion criteria 
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).

Where this trial is running

Norwich, Norfolk and 56 other locations

+7 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary FibrosisIdiopathic pulmonary fibrosisIPFLansoprazoleProton pump inhibitorsCoughFVCForced vital capacity
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.