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
Introduction Idiopathic pulmonary fibrosis (IPF) is a chronic progressive fibrotic lung disease frequently complicated by gastro-oesophageal reflux disease. Although several observational studies and a pilot study have investigated the role of proton pump inhibitors (PPIs) in IPF, their efficacy is...
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BMJ Publishing Group
2025-02-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/15/2/e088604.full |
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| author | Toby M Maher A John Simpson Anthony Cahn David Thickett Luke Vale Allan B Clark Nazia Chaudhuri Ian Forrest Lisa G Spencer Christopher Ward Stephen Jones Ganesh Raghu Andrew M Wilson Helen Parfrey Megan Jones Matthew Hammond Jaclyn Ann Smith Shajahan Wahed |
| author_facet | Toby M Maher A John Simpson Anthony Cahn David Thickett Luke Vale Allan B Clark Nazia Chaudhuri Ian Forrest Lisa G Spencer Christopher Ward Stephen Jones Ganesh Raghu Andrew M Wilson Helen Parfrey Megan Jones Matthew Hammond Jaclyn Ann Smith Shajahan Wahed |
| author_sort | Toby M Maher |
| collection | DOAJ |
| description | Introduction Idiopathic pulmonary fibrosis (IPF) is a chronic progressive fibrotic lung disease frequently complicated by gastro-oesophageal reflux disease. Although several observational studies and a pilot study have investigated the role of proton pump inhibitors (PPIs) in IPF, their efficacy is unknown and there is much debate in international IPF guidelines on their use. We aim to undertake an adequately powered double-blind placebo-controlled randomised multicentre clinical trial to assess the change in forced vital capacity (FVC), cough and other important patient-reported outcomes, following 12-month therapy with PPIs in people with IPF.Methods and analysis A total of 298 patients with IPF diagnosed by a multidisciplinary team according to international guidelines who are not receiving PPIs will be enrolled. Patients are randomised equally to receive two capsules of lansoprazole or two placebo capsules, two times per day for 12 months. The primary outcome for the trial is change in FVC, measured at home, between the first week and last week of the study period. Secondary assessments include cough frequency (in a subgroup) measured using the VitaloJAK cough monitor, the King’s Brief Interstitial Lung Disease questionnaire, the Raghu Scale for Pulmonary Fibrosis, Medical Research Council dyspnoea score, EQ-5D-5L, Leicester Cough Questionnaire, modified DeMeester reflux symptoms questionnaire and opportunistically captured routine lung function measurements. High-resolution CT scoring will be undertaken in a subgroup. The trial is designed to determine whether treating people with IPF with lansoprazole will reduce the reduction in FVC over a year. The COVID-19 pandemic required the study to be undertaken as a remote trial.Ethics and dissemination This study received ethical approval from the East of England Cambridgeshire and Hertfordshire Research Ethics Committee (reference 20/EE/0043; integrated research application system number 269050). Trial results will be published in a peer-reviewed journal upon completion.Trial registration number ISRCTN13526307; ClinicalTrials.gov NCT04965298. |
| format | Article |
| id | doaj-art-f342e7c60fd044a1922bee71137d465f |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-02-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-f342e7c60fd044a1922bee71137d465f2025-02-06T03:15:10ZengBMJ Publishing GroupBMJ Open2044-60552025-02-0115210.1136/bmjopen-2024-088604The 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 trialToby M Maher0A John Simpson1Anthony Cahn2David Thickett3Luke Vale4Allan B Clark5Nazia Chaudhuri6Ian Forrest7Lisa G Spencer8Christopher Ward9Stephen Jones10Ganesh Raghu11Andrew M Wilson12Helen Parfrey13Megan Jones14Matthew Hammond15Jaclyn Ann Smith16Shajahan Wahed17Keck School of Medicine of University of Southern California, Los Angeles, California, USATranslational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UKGlaxoSmithKline Plc, Brentford, UKUniversity of Birmingham School of Clinical and Experimental Medicine, Birmingham, UKHealth Economics Group, Institute of Health and Society, Newcastle University, Newcastle, UKNorwich Medical School, University of East Anglia, Norwich, UKUlster University, Coleraine, UKRoyal Victoria Infirmary, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UKThoracic Medicine, Aintree University Hospitals NHS Foundation Trust, Liverpool, UKTranslational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UKAction for Pulmonary Fibrosis, Peterborough, UKCenter for Interstitial Lung Diseases, University of Washington Medical Center, Seattle, Washington, USANorwich Medical School, University of East Anglia, Norwich, UKPapworth Hospital NHS Foundation Trust, Cambridge, Cambridgeshire, UKNorwich Clinical Trials Unit, University of East Anglia, Norwich, UKNorwich Clinical Trials Unit, University of East Anglia, Norwich, UKDivision of Infection, Immunity and Respiratory Medicine, University of Manchester, Manchester, UKNewcastle Upon Tyne Hospitals NHS Trust, Newcastle Upon Tyne, UKIntroduction Idiopathic pulmonary fibrosis (IPF) is a chronic progressive fibrotic lung disease frequently complicated by gastro-oesophageal reflux disease. Although several observational studies and a pilot study have investigated the role of proton pump inhibitors (PPIs) in IPF, their efficacy is unknown and there is much debate in international IPF guidelines on their use. We aim to undertake an adequately powered double-blind placebo-controlled randomised multicentre clinical trial to assess the change in forced vital capacity (FVC), cough and other important patient-reported outcomes, following 12-month therapy with PPIs in people with IPF.Methods and analysis A total of 298 patients with IPF diagnosed by a multidisciplinary team according to international guidelines who are not receiving PPIs will be enrolled. Patients are randomised equally to receive two capsules of lansoprazole or two placebo capsules, two times per day for 12 months. The primary outcome for the trial is change in FVC, measured at home, between the first week and last week of the study period. Secondary assessments include cough frequency (in a subgroup) measured using the VitaloJAK cough monitor, the King’s Brief Interstitial Lung Disease questionnaire, the Raghu Scale for Pulmonary Fibrosis, Medical Research Council dyspnoea score, EQ-5D-5L, Leicester Cough Questionnaire, modified DeMeester reflux symptoms questionnaire and opportunistically captured routine lung function measurements. High-resolution CT scoring will be undertaken in a subgroup. The trial is designed to determine whether treating people with IPF with lansoprazole will reduce the reduction in FVC over a year. The COVID-19 pandemic required the study to be undertaken as a remote trial.Ethics and dissemination This study received ethical approval from the East of England Cambridgeshire and Hertfordshire Research Ethics Committee (reference 20/EE/0043; integrated research application system number 269050). Trial results will be published in a peer-reviewed journal upon completion.Trial registration number ISRCTN13526307; ClinicalTrials.gov NCT04965298.https://bmjopen.bmj.com/content/15/2/e088604.full |
| spellingShingle | Toby M Maher A John Simpson Anthony Cahn David Thickett Luke Vale Allan B Clark Nazia Chaudhuri Ian Forrest Lisa G Spencer Christopher Ward Stephen Jones Ganesh Raghu Andrew M Wilson Helen Parfrey Megan Jones Matthew Hammond Jaclyn Ann Smith Shajahan Wahed 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | https://bmjopen.bmj.com/content/15/2/e088604.full |
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