{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,29]],"date-time":"2026-05-29T11:18:19Z","timestamp":1780053499689,"version":"3.54.0"},"reference-count":63,"publisher":"BMJ","issue":"2","license":[{"start":{"date-parts":[[2025,2,4]],"date-time":"2025-02-04T00:00:00Z","timestamp":1738627200000},"content-version":"unspecified","delay-in-days":3,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Brainomix","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"name":"Eastern Comprehensive Research Network","award":["N\/A"],"award-info":[{"award-number":["N\/A"]}]},{"DOI":"10.13039\/501100000664","name":"Health Technology Assessment Programme","doi-asserted-by":"publisher","award":["NIHR127479"],"award-info":[{"award-number":["NIHR127479"]}],"id":[{"id":"10.13039\/501100000664","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2025,1,7]]},"published-print":{"date-parts":[[2025,2]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>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\u2019s 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"isrctn\" xlink:href=\"ISRCTN13526307\">ISRCTN13526307<\/jats:ext-link>\n                      ; ClinicalTrials.gov\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT04965298\">NCT04965298<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2024-088604","type":"journal-article","created":{"date-parts":[[2025,2,5]],"date-time":"2025-02-05T05:20:43Z","timestamp":1738732843000},"page":"e088604","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":3,"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"],"prefix":"10.1136","volume":"15","clinical-trial-number":[{"clinical-trial-number":"isrctn13526307","registry":"10.18810\/isrctn"},{"clinical-trial-number":"nct04965298","registry":"10.18810\/clinical-trials-gov"}],"author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-4798-5092","authenticated-orcid":false,"given":"Megan","family":"Jones","sequence":"first","affiliation":[{"name":"Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Anthony","family":"Cahn","sequence":"additional","affiliation":[{"name":"GlaxoSmithKline Plc, Brentford, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nazia","family":"Chaudhuri","sequence":"additional","affiliation":[{"name":"Ulster University, Coleraine, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Allan B","family":"Clark","sequence":"additional","affiliation":[{"name":"Norwich Medical School, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ian","family":"Forrest","sequence":"additional","affiliation":[{"name":"Royal Victoria Infirmary, The Newcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Matthew","family":"Hammond","sequence":"additional","affiliation":[{"name":"Norwich Clinical Trials Unit, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stephen","family":"Jones","sequence":"additional","affiliation":[{"name":"Action for Pulmonary Fibrosis, Peterborough, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Toby M","family":"Maher","sequence":"additional","affiliation":[{"name":"Keck School of Medicine of University of Southern California, Los Angeles, California, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helen","family":"Parfrey","sequence":"additional","affiliation":[{"name":"Papworth Hospital NHS Foundation Trust, Cambridge, Cambridgeshire, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ganesh","family":"Raghu","sequence":"additional","affiliation":[{"name":"Center for Interstitial Lung Diseases, University of Washington Medical Center, Seattle, Washington, USA"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A John","family":"Simpson","sequence":"additional","affiliation":[{"name":"Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8837-4928","authenticated-orcid":false,"given":"Jaclyn Ann","family":"Smith","sequence":"additional","affiliation":[{"name":"Division of Infection, Immunity and Respiratory Medicine, University of Manchester, Manchester, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3558-992X","authenticated-orcid":false,"given":"Lisa G","family":"Spencer","sequence":"additional","affiliation":[{"name":"Thoracic Medicine, Aintree University Hospitals NHS Foundation Trust, Liverpool, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"David","family":"Thickett","sequence":"additional","affiliation":[{"name":"University of Birmingham School of Clinical and Experimental Medicine, Birmingham, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Luke","family":"Vale","sequence":"additional","affiliation":[{"name":"Health Economics Group, Institute of Health and Society, Newcastle University, Newcastle, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shajahan","family":"Wahed","sequence":"additional","affiliation":[{"name":"Newcastle Upon Tyne Hospitals NHS Trust, Newcastle Upon Tyne, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6954-9611","authenticated-orcid":false,"given":"Christopher","family":"Ward","sequence":"additional","affiliation":[{"name":"Translational and Clinical Research Institute, Newcastle University, Newcastle upon Tyne, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5514-4867","authenticated-orcid":false,"given":"Andrew M","family":"Wilson","sequence":"additional","affiliation":[{"name":"Norwich Medical School, University of East Anglia, Norwich, UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2025,2,5]]},"reference":[{"key":"2025121511563583000_15.2.e088604.1","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.06.00037005"},{"key":"2025121511563583000_15.2.e088604.2","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00101212"},{"key":"2025121511563583000_15.2.e088604.3","doi-asserted-by":"crossref","first-page":"352","DOI":"10.1049\/syb2.12081","article-title":"Prediction and analysis of genetic effect in idiopathic pulmonary fibrosis and gastroesophageal reflux disease","volume":"17","author":"Chen","year":"2023","journal-title":"IET Syst Biol"},{"key":"2025121511563583000_15.2.e088604.4","doi-asserted-by":"publisher","DOI":"10.1016\/j.chest.2023.02.038"},{"key":"2025121511563583000_15.2.e088604.5","doi-asserted-by":"crossref","DOI":"10.1183\/13993003.01585-2022","article-title":"The causal relationship between gastro-oesophageal reflux disease and idiopathic pulmonary fibrosis: a bidirectional two-sample Mendelian randomisation study","volume":"61","author":"Reynolds","year":"2023","journal-title":"Eur Respir J"},{"key":"2025121511563583000_15.2.e088604.6","doi-asserted-by":"publisher","DOI":"10.1016\/j.cgh.2022.01.025"},{"key":"2025121511563583000_15.2.e088604.7","doi-asserted-by":"publisher","DOI":"10.1136\/gutjnl-2018-318115"},{"key":"2025121511563583000_15.2.e088604.8","doi-asserted-by":"crossref","DOI":"10.1183\/13993003.00376-2018","article-title":"The effect of anti-acid therapy on survival in idiopathic pulmonary fibrosis: a methodological review of observational studies","volume":"51","author":"Tran","year":"2018","journal-title":"Eur Respir J"},{"key":"2025121511563583000_15.2.e088604.9","doi-asserted-by":"crossref","first-page":"1405","DOI":"10.1016\/j.chest.2018.03.008","article-title":"Treatment of Gastroesophageal Reflux in Patients With Idiopathic Pulmonary Fibrosis: A Systematic Review and Meta-Analysis","volume":"153","author":"Fidler","year":"2018","journal-title":"Chest"},{"key":"2025121511563583000_15.2.e088604.10","doi-asserted-by":"crossref","first-page":"833","DOI":"10.1513\/AnnalsATS.202102-172OC","article-title":"Antacid Medication and Antireflux Surgery in Patients with Idiopathic Pulmonary Fibrosis: A Systematic Review and Meta-Analysis","volume":"19","author":"Khor","year":"2022","journal-title":"Annals ATS"},{"key":"2025121511563583000_15.2.e088604.11","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2018-212102"},{"key":"2025121511563583000_15.2.e088604.12","doi-asserted-by":"crossref","DOI":"10.1186\/s12967-015-0614-x","article-title":"Pleiotropic effect of the proton pump inhibitor esomeprazole leading to suppression of lung inflammation and fibrosis","volume":"13","author":"Ghebremariam","year":"2015","journal-title":"J Transl Med"},{"key":"2025121511563583000_15.2.e088604.13","doi-asserted-by":"crossref","DOI":"10.3389\/fphar.2017.00016","article-title":"Therapeutic Efficacy of Esomeprazole in Cotton Smoke-Induced Lung Injury Model","volume":"8","author":"Nelson","year":"2017","journal-title":"Front Pharmacol"},{"key":"2025121511563583000_15.2.e088604.14","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201512-2316PP"},{"key":"2025121511563583000_15.2.e088604.15","doi-asserted-by":"crossref","DOI":"10.1371\/journal.pone.0128004","article-title":"Risk of community-acquired pneumonia with outpatient proton-pump inhibitor therapy: a systematic review and meta-analysis","volume":"10","author":"Lambert","year":"2015","journal-title":"PLoS One"},{"key":"2025121511563583000_15.2.e088604.16","doi-asserted-by":"crossref","first-page":"273","DOI":"10.1177\/2042098617715381","article-title":"Adverse effects of proton-pump inhibitor use in older adults: a review of the evidence","volume":"8","author":"Maes","year":"2017","journal-title":"Ther Adv Drug Saf"},{"key":"2025121511563583000_15.2.e088604.17","doi-asserted-by":"crossref","DOI":"10.1186\/s13756-018-0365-6","article-title":"Risk factors for poor outcome in community-onset Clostridium difficile infection","volume":"7","author":"Lee","year":"2018","journal-title":"Antimicrob Resist Infect Control"},{"key":"2025121511563583000_15.2.e088604.18","article-title":"The Role of Proton Pump Inhibitors in the Realm of Idiopathic Pulmonary Fibrosis and its Associated Comorbidities: A Systematic Review","volume":"16","author":"Iftikhar","year":"2024","journal-title":"Cureus"},{"key":"2025121511563583000_15.2.e088604.19","doi-asserted-by":"crossref","DOI":"10.3390\/ph15081033","article-title":"Gastroesophageal Reflux Disease in Idiopathic Pulmonary Fibrosis: Viewer or Actor? To Treat or Not to Treat?","volume":"15","author":"Ruaro","year":"2022","journal-title":"Pharmaceuticals (Basel)"},{"key":"2025121511563583000_15.2.e088604.20","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201206-1010PP"},{"key":"2025121511563583000_15.2.e088604.21","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2012-202580"},{"key":"2025121511563583000_15.2.e088604.22","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMp1500526"},{"key":"2025121511563583000_15.2.e088604.23","doi-asserted-by":"crossref","first-page":"428","DOI":"10.1136\/thoraxjnl-2013-204202","article-title":"Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: provisional core sets of domains and instruments for use in clinical trials","volume":"69","author":"Saketkoo","year":"2014","journal-title":"Thorax"},{"key":"2025121511563583000_15.2.e088604.24","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00200614"},{"key":"2025121511563583000_15.2.e088604.25","doi-asserted-by":"crossref","DOI":"10.1136\/bmj.m1172","article-title":"Clinical trials suspended in UK to prioritise covid-19 studies and free up staff","volume":"368","author":"Thornton","year":"2020","journal-title":"BMJ"},{"key":"2025121511563583000_15.2.e088604.26","unstructured":"File:\/\/ueahome\/eresfmh2\/wm057\/data\/downloads\/cem_cmo_2020_011.pdf. England N Letter, 2020."},{"key":"2025121511563583000_15.2.e088604.27","unstructured":"Scottish Government . Definitions of patients at high risk of COVID-19 infection, Available: https:\/\/www.sign.ac.uk\/media\/1373\/sg_shielding_guidance.pdf"},{"key":"2025121511563583000_15.2.e088604.28","doi-asserted-by":"crossref","DOI":"10.1186\/s12955-014-0124-1","article-title":"The psychometric properties of the St George\u2019s Respiratory Questionnaire (SGRQ) in patients with idiopathic pulmonary fibrosis: a literature review","volume":"12","author":"Swigris","year":"2014","journal-title":"Health Qual Life Outcomes"},{"key":"2025121511563583000_15.2.e088604.29","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.202202-0399ST"},{"key":"2025121511563583000_15.2.e088604.30","unstructured":"Labtests online-UK . Reference Ranges & What They Mean, Available: https:\/\/www.labtestsonline.org.uk\/articles\/laboratory-test-reference-ranges"},{"key":"2025121511563583000_15.2.e088604.31","unstructured":"NICE . Idiopathic pulmonary fibrosis in adults: diagnosis and management 2017, Clinical guideline [CG163], Available: https:\/\/www.nice.org.uk\/guidance\/CG163"},{"key":"2025121511563583000_15.2.e088604.32","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201908-1590ST"},{"key":"2025121511563583000_15.2.e088604.33","first-page":"S728","article-title":"An update on measurement and monitoring of cough: what are the important study endpoints?","volume":"6","author":"Spinou","year":"2014","journal-title":"J Thorac Dis"},{"key":"2025121511563583000_15.2.e088604.34","doi-asserted-by":"publisher","DOI":"10.1186\/1745-9974-6-4"},{"key":"2025121511563583000_15.2.e088604.35","doi-asserted-by":"publisher","DOI":"10.1136\/thorax.58.4.339"},{"key":"2025121511563583000_15.2.e088604.36","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2012-201581"},{"key":"2025121511563583000_15.2.e088604.37","doi-asserted-by":"crossref","DOI":"10.1183\/13993003.00917-2021","article-title":"R-scale for pulmonary fibrosis: a simple, visual tool for the assessment of health-related quality of life","volume":"59","author":"Scallan","year":"2022","journal-title":"Eur Respir J"},{"key":"2025121511563583000_15.2.e088604.38","doi-asserted-by":"crossref","DOI":"10.1177\/14799731211033925","article-title":"Psychometric properties of patient reported outcome measures in idiopathic pulmonary fibrosis","volume":"18","author":"Kim","year":"2021","journal-title":"Chron Respir Dis"},{"key":"2025121511563583000_15.2.e088604.39","doi-asserted-by":"publisher","DOI":"10.1093\/occmed\/kqx086"},{"key":"2025121511563583000_15.2.e088604.40","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-011-9903-x"},{"key":"2025121511563583000_15.2.e088604.41","doi-asserted-by":"crossref","DOI":"10.1186\/1471-2482-13-S2-S13","article-title":"Is the advanced age a contraindication to GERD laparoscopic surgery? Results of a long term follow-up","volume":"13 Suppl 2","author":"Fei","year":"2013","journal-title":"BMC Surg"},{"key":"2025121511563583000_15.2.e088604.42","doi-asserted-by":"publisher","DOI":"10.1016\/0165-1781(89)90047-4"},{"key":"2025121511563583000_15.2.e088604.43","doi-asserted-by":"publisher","DOI":"10.1016\/S0022-3999(02)00330-6"},{"key":"2025121511563583000_15.2.e088604.44","doi-asserted-by":"publisher","DOI":"10.1378\/chest.15-0903"},{"key":"2025121511563583000_15.2.e088604.45","unstructured":"NIHR . Participant in Research Experience Survey (PRES), Available: https:\/\/www.nihr.ac.uk\/patients-carers-and-the-public\/participant-in-research-experience-survey.htm"},{"key":"2025121511563583000_15.2.e088604.46","doi-asserted-by":"publisher","DOI":"10.1001\/jama.2020.22960"},{"key":"2025121511563583000_15.2.e088604.47","doi-asserted-by":"publisher","DOI":"10.1136\/thoraxjnl-2012-202403"},{"key":"2025121511563583000_15.2.e088604.48","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201209-1686OC"},{"key":"2025121511563583000_15.2.e088604.49","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201506-1063ST"},{"key":"2025121511563583000_15.2.e088604.50","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.2009-040GL"},{"key":"2025121511563583000_15.2.e088604.51","doi-asserted-by":"crossref","DOI":"10.1164\/rccm.202207-1420LE","article-title":"Anti-acid Therapies in Idiopathic Pulmonary Fibrosis: Premature to Dismiss?","volume":"206","author":"Crowley","year":"2022","journal-title":"Am J Respir Crit Care Med"},{"key":"2025121511563583000_15.2.e088604.52","doi-asserted-by":"crossref","first-page":"1542","DOI":"10.1164\/rccm.202305-0786LE","article-title":"Reply to Cottin et al., to Johannson et al., to Scholand and Wells, and to Crowley et al","volume":"207","author":"Raghu","year":"2023","journal-title":"Am J Respir Crit Care Med"},{"key":"2025121511563583000_15.2.e088604.53","doi-asserted-by":"crossref","DOI":"10.1186\/s12931-018-0810-3","article-title":"A home monitoring program including real-time wireless home spirometry in idiopathic pulmonary fibrosis: a pilot study on experiences and barriers","volume":"19","author":"Moor","year":"2018","journal-title":"Respir Res"},{"key":"2025121511563583000_15.2.e088604.54","doi-asserted-by":"crossref","first-page":"989","DOI":"10.1164\/rccm.201511-2152OC","article-title":"Daily Home Spirometry: An Effective Tool for Detecting Progression in Idiopathic Pulmonary Fibrosis","volume":"194","author":"Russell","year":"2016","journal-title":"Am J Respir Crit Care Med"},{"key":"2025121511563583000_15.2.e088604.55","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.02406-2016"},{"key":"2025121511563583000_15.2.e088604.56","doi-asserted-by":"crossref","DOI":"10.1183\/13993003.01518-2020","article-title":"Home spirometry in patients with idiopathic pulmonary fibrosis: data from the INMARK trial","volume":"58","author":"Noth","year":"2021","journal-title":"Eur Respir J"},{"key":"2025121511563583000_15.2.e088604.57","doi-asserted-by":"crossref","first-page":"147","DOI":"10.1016\/S2213-2600(19)30341-8","article-title":"Pirfenidone in patients with unclassifiable progressive fibrosing interstitial lung disease: a double-blind, randomised, placebo-controlled, phase 2 trial","volume":"8","author":"Maher","year":"2020","journal-title":"Lancet Respir Med"},{"key":"2025121511563583000_15.2.e088604.58","unstructured":"MHRA HaCRW, NHS Scotland, HSC Health and Social Care, HRA . Joint statement on seeking consent by electronic methods 2018, Available: https:\/\/www.hra.nhs.uk\/about-us\/news-updates\/hra-and-mhra-publish-joint-statement-seeking-and-documenting-consent-using-electronic-methods-econsent"},{"key":"2025121511563583000_15.2.e088604.59","unstructured":"Government Services . Getting informed consent for user research, 2018. Available: https:\/\/www.gov.uk\/service-manual\/user-research\/getting-users-consent-for-research"},{"key":"2025121511563583000_15.2.e088604.60","doi-asserted-by":"crossref","DOI":"10.1016\/j.ijmedinf.2020.104271","article-title":"Electronic consenting for conducting research remotely: A review of current practice and key recommendations for using e-consenting","volume":"143","author":"Skelton","year":"2020","journal-title":"Int J Med Inform"},{"key":"2025121511563583000_15.2.e088604.61","doi-asserted-by":"crossref","DOI":"10.1186\/s13063-022-06959-6","article-title":"Electronic informed consent: effects on enrolment, practical and economic benefits, challenges, and drawbacks-a systematic review of studies within randomized controlled trials","volume":"24","author":"Mazzochi","year":"2023","journal-title":"Trials"},{"key":"2025121511563583000_15.2.e088604.62","doi-asserted-by":"publisher","DOI":"10.1378\/chest.10-0438"},{"key":"2025121511563583000_15.2.e088604.63","doi-asserted-by":"crossref","first-page":"806","DOI":"10.1016\/S2213-2600(17)30310-7","article-title":"A novel formulation of inhaled sodium cromoglicate (PA101) in idiopathic pulmonary fibrosis and chronic cough: a randomised, double-blind, proof-of-concept, phase 2 trial","volume":"5","author":"Birring","year":"2017","journal-title":"Lancet Respir Med"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2024-088604","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T19:56:46Z","timestamp":1765828606000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2024-088604"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2]]},"references-count":63,"journal-issue":{"issue":"2","published-online":{"date-parts":[[2025,2,5]]},"published-print":{"date-parts":[[2025,2]]}},"alternative-id":["10.1136\/bmjopen-2024-088604"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2024-088604","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2]]}}}