Treating People With Idiopathic Pulmonary Fibrosis With the Addition of Lansoprazole (TIPAL)

December 15, 2025 updated by: Norfolk and Norwich University Hospitals NHS Foundation Trust

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Idiopathic pulmonary fibrosis (IPF) is a progressive and usually fatal lung disease with a poor prognosis. IPF patients frequently have other medical conditions as well, with reflux disease being one of the most common. Previous studies and a review of data already collected suggest that treatments used to reduce reflux disease symptoms, proton pump inhibitors (PPIs), may reduce IPF disease progression and improve survival rates. Current IPF treatment guidelines cautiously advise PPI treatment for IPF patients, however there hasn't been a study which investigates this specifically yet even though doctors and government groups have said one is needed. There are thought to be links between cough, reflux, sleep and IPF. As a result we will be asking a sub-group of patients to complete two 24 hour sessions of cough frequency monitoring as a sub-study. Some of these participants may be asked to wear a wrist-based activity and sleep monitor during these periods also. In addition, we will ask patients to complete two questionnaires on their sleeping habits to further investigate this link. At the end of the trial, we will able to recommend whether or not IPF patients should take PPIs routinely or not.

This project is a clinical trial of an investigational medicinal product (drug). The drug is well established and approved for use for another medical condition. The drug will be assessed against placebo (dummy) tablets, with patients allocated to either group by chance. Patients on the drug and dummy tablets will be assessed at the same time. Neither patients nor their doctors or the research team will know which treatment they have been allocated to. We will be running the study at approximately 37 hospitals across the UK.

All study visits may take place remotely without the participant needing to attend the hospital. However, face-to-face onsite visits are also permitted if preferred/feasible. All participants will receive central training via video call, with a trained clinical physiologist, following consent on how to complete domiciliary spirometry assessments. Further training will be provided during follow-up if deemed required following a review of the data. Questionnaires will be completed either electronically or by post.

Potentially eligible patients will be approached remotely or in clinic after being identified from local patient lists/databases. They will be given/sent the relevant study literature to consider participation in the study and will be followed-up by a member of the local research team after they have had at least 24hours to consider participating.

Interested patients will be invited to a virtual or face-to-face screening appointment where they will be counselled on the study and what it entails in order to provide informed consent to participate. The patient will then be asked to complete baseline questionnaires, provide demographic, medical history and concomitant medication, and any other relevant study information, complete spirometry assessments over 5 days at home using a domiciliary spirometer and provide a blood sample for safety in order for the investigator to confirm their eligibility for the trial. Patients may also provide a blood sample for analysis in future research if the visit takes place at the recruiting site. In addition, eligible participants may complete a 24hour period of cough frequency monitoring, and activity and sleep monitoring if applicable, if they have consented to do so. Patients in receipt of PPIs without a clear clinical indication for them at consent, will undergo a two week wash-out period (following agreement from the patient and their GP) to ascertain whether it is safe to stop this treatment and monitor whether their symptoms subside. Patients who remain asymptomatic at the end of this period will proceed to enter the study. For those whose symptoms return, PPI treatment will recommence and they will not enter the study. Once the results of all baseline assessments are known, patients will be randomised.

Participants will receive an initial 6 month supply of trial medication and be instructed to take 2 tablets twice daily (approximately 12 hours apart), 30 minutes before meals, for 12 months. Participants will commence weekly domiciliary spirometry assessments, for 12 months, from this point onwards.

At 3 months post-randomisation, participants will complete the relevant questionnaires and provide blood samples for safety checks. Domiciliary spirometry assessments remain ongoing. Participants involved in the sub-study will again undergo cough frequency monitoring, and activity and sleep monitoring if applicable, for a final 24 hour period. Patients will be asked to report any changes in their medical history, medication and any events which they have experienced since their last visit.

Participants will be contacted again at 6 months post-randomisation where they we will complete questionnaires and provide a safety blood samples. Domiciliary spirometry assessments remain ongoing. Participants will again be asked to report any changes in their medical history, medication and any events which they have experienced since their last visit. Participant adherence to the trial medication will be checked. A final supply of trial medication will be dispensed.

At 9 months post-randomisation, local site staff will contact patients to record any changes in their medical history, medication and any events experienced since their last visit. Patients will be required to complete the required questionnaires and provide a blood sample for safety checks.

The final study assessments will be at 12 months post-randomisation. Patients will be required to complete all necessary questionnaires, provide a blood sample for safety analysis and a final set of domiciliary spirometry assessments will occur over a 5 day consecutive period. If participants have consented to do so, an additional blood sample will be taken for analysis in future research studies if the visit occurs on site. Patients will be required to report any changes in their medical history, medication and any events they have experienced since their last report to site staff.

If participants are suspected of or confirmed to have experienced any of the following they may reduce the dose of their trial treatment, at any point during the study, to 1 tablet, twice daily (approximately 12 hours apart), 30 minutes before meals: infection including pneumonia, Clostridium difficile infection and/or hypomagnesaemia. Participants may also reduce dose if the participant or clinician wishes them to do so.

A blood sample for genotype analysis may be taken at any study timepoint which occurs face-to-face, if the participants consents to provide one. Safety blood samples will be taken at the participant's GP surgery where visits take place remotely. Remote follow-up may take place via video or phone call.

Study Type

Interventional

Enrollment (Estimated)

298

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United Kingdom
      • Aberdeen, United Kingdom, AB15 6RE
        • Recruiting
        • NHS Grampian
        • Contact:
        • Principal Investigator:
          • Owen Dempsey
      • Antrim, United Kingdom, BT41 2RL
      • Basingstoke, United Kingdom, RG24 9NA
        • Completed
        • Hampshire Hospitals NHS Foundation Trust
      • Bath, United Kingdom, BA1 3NG
        • Recruiting
        • Royal United Hospitals Bath NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Tom Hartley
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Gareth Walters
      • Birmingham, United Kingdom, B15 2GW
        • Recruiting
        • University Hospitals Birmingham NHS Foundation Trust (QEHB)
        • Contact:
        • Principal Investigator:
          • David Thickett
      • Blackburn, United Kingdom, BB2 3HH
        • Completed
        • East Lancashire Hospitals NHS Trust
      • Blackpool, United Kingdom, FY3 8NR
        • Not yet recruiting
        • Blackpool Teaching Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Thomas Bongers
      • Bristol, United Kingdom, BS10 5NB
        • Completed
        • North Bristol NHS Trust
      • Bury St Edmunds, United Kingdom, IP33 2QZ
        • Recruiting
        • West Suffolk NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Ludmila Shulgina
      • Cambridge, United Kingdom, CB2 0AY
        • Recruiting
        • Royal Papworth Hospital NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Helen Parfrey
      • Cardiff, United Kingdom, CF14 4XW
        • Completed
        • Cardiff and Vale University Health Board
      • Carmarthen, United Kingdom, SA31 3BB
        • Recruiting
        • Hywel Dda University Health Board
        • Contact:
        • Principal Investigator:
          • Mark Andrews
      • Craigavon, United Kingdom, BT63 5QQ
        • Completed
        • Southern Health & Social Care Trust
      • Crewe, United Kingdom, CW1 4QJ
        • Completed
        • Mid Cheshire Hospitals NHS Foundation Trust
      • Doncaster, United Kingdom, DN2 5LT
        • Recruiting
        • Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Alisa Holbourn
      • Dundee, United Kingdom, DD2 1UB
        • Recruiting
        • NHS Tayside
        • Contact:
        • Principal Investigator:
          • Andrew Goudie
      • Exeter, United Kingdom, EX2 5DW
        • Recruiting
        • Royal Devon University Healthcare NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Stefan Stanel
      • Frimley, United Kingdom, GU16 7UJ
        • Completed
        • Frimley Health NHS Foundation Trust
      • Harlow, United Kingdom, CM20 1QX
        • Recruiting
        • The Princess Alexandra Hospital NHS Trust
        • Contact:
        • Principal Investigator:
          • Muhammed Anward
      • Huddersfield, United Kingdom, HD3 3EA
        • Completed
        • Calderdale and Huddersfield NHS Foundation Trust
      • Hull, United Kingdom, HU3 2JZ
        • Recruiting
        • Hull University Teaching Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Simon Hart
      • Kendal, United Kingdom, LA9 7RG
        • Recruiting
        • University Hospitals of Morecambe Bay NHS Foundation Trust
        • Principal Investigator:
          • Timothy Gatheral
        • Contact:
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • Leeds Teaching Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Paul Beirne
      • Leicester, United Kingdom, LE1 5WW
        • Recruiting
        • University Hospitals of Leicester NHS Trust
        • Principal Investigator:
          • Fasihul Khan
        • Contact:
      • Liverpool, United Kingdom, L7 8XP
      • London, United Kingdom, W2 1NY
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
        • Principal Investigator:
          • Robina Coker
      • London, United Kingdom, NW1 2PG
        • Recruiting
        • University College London Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Joanna Porter
      • London, United Kingdom, E1 2ES
        • Recruiting
        • Barts Health NHS Trust
        • Contact:
        • Principal Investigator:
          • Richard Tosner
      • London, United Kingdom, SE13 6LH
        • Recruiting
        • Lewisham and Greenwich NHS Trust
        • Contact:
        • Principal Investigator:
          • Tom Simpson
      • London, United Kingdom, SW3 6PY
        • Recruiting
        • Royal Brompton & Harefield NHS Foundation Trust
        • Principal Investigator:
          • Philip Molyneaux
        • Contact:
      • Londonderry, United Kingdom, BT47 6SB
      • Luton, United Kingdom, LU4 0DZ
        • Completed
        • Bedfordshire Hospitals NHS Foundation Trust
      • Macclesfield, United Kingdom, SK10 3BL
        • Completed
        • East Cheshire NHS Trust
      • Manchester, United Kingdom, M13 9WL
        • Recruiting
        • Manchester University NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Conal Hayton
      • Newcastle upon Tyne, United Kingdom, NE7 7DN
        • Recruiting
        • The Newcastle Upon Tyne Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Ian Forrest
      • North Shields, United Kingdom, NE29 8NH
      • Nottingham, United Kingdom, NG5 1PB
        • Completed
        • Nottingham University Hospitals NHS Trust
      • Oxford, United Kingdom, OX3 9DU
        • Completed
        • Oxford University Hospitals NHS Foundation Trust
      • Portsmouth, United Kingdom, PO6 3LY
        • Completed
        • Portsmouth Hospitals NHS Trust
      • Preston, United Kingdom, PR2 9HT
        • Completed
        • Lancashire Teaching Hospitals NHS Foundation Trust
      • Sheffield, United Kingdom, S10 2JF
        • Completed
        • Sheffield Teaching Hospitals NHS Foundation Trust
      • Shrewsbury, United Kingdom, SY3 8XQ
        • Recruiting
        • Shrewsbury and Telford Hospital NHS Trust
        • Contact:
        • Principal Investigator:
          • Richard Heinick
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • University Hospital Southampton NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Sophie Fletcher
      • Stevenage, United Kingdom, SG1 4AB
        • Recruiting
        • East and North Hertfordshire NHS Trust
        • Contact:
        • Principal Investigator:
          • Ritesh Kumar
      • Stockton-on-Tees, United Kingdom, TS19 8PE
        • Recruiting
        • North Tees and Hartlepool NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Graham Miller
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Recruiting
        • University Hospitals of North Midlands
        • Contact:
        • Principal Investigator:
          • Helen Stone
      • Sunderland, United Kingdom, SR4 7TP
        • Recruiting
        • South Tyneside and Sunderland NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Andrew Macnair
      • Sutton in Ashfield, United Kingdom, NG17 4JL
        • Recruiting
        • Sherwood Forest Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Khaled Amsha
      • Taunton, United Kingdom, TA1 5DA
      • Teddington, United Kingdom, TW11 8HU
        • Recruiting
        • Kingston and Richmond NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Veronica Smith
      • Torquay, United Kingdom, TQ2 7AA
        • Recruiting
        • Torbay and South Devon NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Louise Anning
      • Wigan, United Kingdom, WN1 2NN
        • Recruiting
        • Wrightington, Wigan and Leigh NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Abdul Ashish
      • Wolverhampton, United Kingdom, WV10 0QP
        • Recruiting
        • The Royal Wolverhampton NHS Trust
        • Contact:
        • Principal Investigator:
          • Ahmed Fahim
      • Worcester, United Kingdom, WR5 1DD
        • Recruiting
        • Worcestershire Acute Hospitals NHS Trust
        • Contact:
        • Principal Investigator:
          • Stephen O'Hickey
      • York, United Kingdom, YO31 8HE
        • Recruiting
        • York and Scarborough Teaching Hospitals NHS Foundation Trust
        • Contact:
        • Principal Investigator:
          • Caroline Everett
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Recruiting
        • Norfolk and Norwich University Hospitals NHS Foundation Trust
        • Principal Investigator:
          • Andrew Wilson
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Lansoprazole
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.
Other: Matched placebo
Matched placebo 2 capsules twice daily, 12 hours apart, for 12 months. Treatment should be taken at least 30 minutes before food.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change in percent predicted (%) forced vital capacity (FVC)
Time Frame: 12 months post-randomisation
Absolute change in percent predicted (%) forced vital capacity (FVC) at 12 months post-randomisation of lansoprazole versus placebo.
12 months post-randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cough frequency
Time Frame: 3 months post-randomisation
Cough frequency measured using a VitaloJAK cough monitor over a 24h period.
3 months post-randomisation
Cough score
Time Frame: 3, 6, 9 and 12 months post-randomisation
Cough score measured using a 100mm visual analogue scale (VAS).
3, 6, 9 and 12 months post-randomisation
Cough related
Time Frame: 3, 6, 9 and 12 months post-randomisation
Cough related quality of life measured by the Leicester Cough Questionnaire (LCQ).
3, 6, 9 and 12 months post-randomisation
Breathlessness
Time Frame: 3, 6, 9 and 12 months post-randomisation
Breathlessness measured by the Medical Research Council Dyspnoea scale.
3, 6, 9 and 12 months post-randomisation
Disease specific quality of life
Time Frame: 3, 6, 9 and 12 months post-randomisation
Disease specific quality of life measured using the King's Brief Interstitial Lung Disease (K-BILD) questionnaire.
3, 6, 9 and 12 months post-randomisation
Health related quality of life
Time Frame: 3, 6, 9 and 12 months post-randomisation
Health related quality of life measured using the EQ-5D-5L questionnaire (quality adjusted life years will be estimated).
3, 6, 9 and 12 months post-randomisation
Total lung diffusing capacity of carbon monoxide
Time Frame: 3, 6 and 12 months post-randomisation
Total lung diffusing capacity of carbon monoxide (DLCO) measured (corrected for haemoglobin) where possible.
3, 6 and 12 months post-randomisation
Laboratory assessment
Time Frame: 3, 6 and 12 months post-randomisation
Laboratory assessment of FVC and FEV1 where possible.
3, 6 and 12 months post-randomisation
Sleep quality
Time Frame: 3 and 12 months post-randomisation
Sleep quality measured by the short Pittsburgh Sleep Quality Index (PSQI).
3 and 12 months post-randomisation
Reflux characteristics
Time Frame: 3 and 12 months post-randomisation
Reflux characteristics measured by the DeMeester score.
3 and 12 months post-randomisation
Participant acceptability
Time Frame: 12 months post-randomisation
Participant acceptability measured by a study-specific questionnaire.
12 months post-randomisation
Risk of sleep apnoea
Time Frame: 12 months post-randomisation
Risk of sleep apnoea measured by the STOP-Bang questionnaire.
12 months post-randomisation
Progression free survival
Time Frame: 12 months post-randomisation
Progression free survival (with progression defined as time from date of randomisation to week of all-cause death, lung transplant or a 10% absolute reduction in FVC % predicted from baseline measured by weekly domiciliary spirometry).
12 months post-randomisation
Hospital-free survival defined as death
Time Frame: 12 months post-randomisation
Hospital-free survival defined as death (all-cause) or first non-elective (all-cause) hospital admission.
12 months post-randomisation
Respiratory related hospital free survival
Time Frame: 12 months post-randomisation
Respiratory related hospital free survival.
12 months post-randomisation
The decline and rate of decline in absolute %FVC
Time Frame: Measured over the course of 12 months
The decline and rate of decline in absolute %FVC based on %FVC measured weekly by domiciliary spirometry.
Measured over the course of 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Norfolk and Norwich University Hospitals NHS Foundation Trust

Collaborators

Norwich Clinical Trials Unit

Investigators

  • Study Chair: Professor Andrew Wilson, Norfolk and Norwich University Hospitals NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 16, 2021

Primary Completion (Estimated)

February 28, 2026

Study Completion (Estimated)

February 28, 2026

Study Registration Dates

First Submitted

July 7, 2021

First Submitted That Met QC Criteria

July 7, 2021

First Posted (Actual)

July 16, 2021

Study Record Updates

Last Update Posted (Estimated)

December 22, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 269050-80-06-19
  • 2020-000041-14 (EudraCT Number)
  • 269050 (Other Identifier: IRAS number)
  • ISRCTN13526307 (Other Identifier: ISRCTN number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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