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.

作者信息

Jones Megan, Cahn Anthony, Chaudhuri Nazia, Clark Allan B, Forrest Ian, Hammond Matthew, Jones Stephen, Maher Toby M, Parfrey Helen, Raghu Ganesh, Simpson A John, Smith Jaclyn Ann, Spencer Lisa G, Thickett David, Vale Luke, Wahed Shajahan, Ward Christopher, Wilson Andrew M

机构信息

Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK.

GlaxoSmithKline Plc, Brentford, UK.

出版信息

BMJ Open. 2025 Feb 5;15(2):e088604. doi: 10.1136/bmjopen-2024-088604.

DOI:10.1136/bmjopen-2024-088604

PMID:39909521

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11800218/

Abstract

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.