{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,15]],"date-time":"2026-10-15T18:46:41Z","timestamp":1792090001510,"version":"4.4.0"},"reference-count":49,"publisher":"European Respiratory Society (ERS)","issue":"5","license":[{"start":{"date-parts":[[2023,3,1]],"date-time":"2023-03-01T00:00:00Z","timestamp":1677628800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.ersjournals.com\/user-licence"}],"funder":[{"DOI":"10.13039\/100001003","name":"Boehringer Ingelheim","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100001003","id-type":"DOI","asserted-by":"publisher"}]},{"DOI":"10.13039\/501100000925","name":"National Health and Medical Research Council","doi-asserted-by":"publisher","award":["2008255"],"award-info":[{"award-number":["2008255"]}],"id":[{"id":"10.13039\/501100000925","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2023,2,8]]},"published-print":{"date-parts":[[2023,5]]},"abstract":"<jats:sec><jats:title>Background<\/jats:title><jats:p>Little is known about generalisability of randomised controlled trials (RCTs) for idiopathic pulmonary fibrosis (IPF). We evaluated eligibility criteria for phase III IPF RCTs to determine their representativeness in clinical registries, and calculated forced vital capacity (FVC) changes according to eligibility criteria.<\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p>Common eligibility criteria used in &gt;60% of IPF RCTs were identified from a literature search and applied to patients with IPF from prospective Australian and Canadian registries. Additional pre-specified criteria of 6-min walk distance (6MWD) and different measures of preceding disease progression were also evaluated. Joint longitudinal-survival modelling was used to compare FVC decline according to eligibility for individual and composite criteria.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Out of 990 patients with IPF, 527 (53%) met all common RCT eligibility criteria at the first clinic visit, including 343 with definite IPF and 184 with radiological probable usual interstitial pneumonia pattern without histological confirmation (<jats:italic>i.e.<\/jats:italic>provisional IPF). The percentages of eligible patients for landmark RCTs of nintedanib and pirfenidone were 19\u201350%. Adding 6MWD \u2265150\u2005m and different measures of preceding disease progression to the composite common criteria reduced the percentages of patients meeting eligibility to 52% (n=516) and 4\u201318% (n=12\u201361), respectively. Patients meeting the composite common criteria had less-rapid 1-year FVC decline than those who did not (\u221290<jats:italic>versus<\/jats:italic>\u2212103\u2005mL, p=0.01). Definite IPF generally had more-rapid 1-year FVC decline compared to provisional IPF.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Eligibility criteria of previous IPF RCTs have limited generalisability to clinical IPF populations, with FVC decline differing between eligible and ineligible populations.<\/jats:p><\/jats:sec>","DOI":"10.1183\/13993003.02163-2022","type":"journal-article","created":{"date-parts":[[2023,3,6]],"date-time":"2023-03-06T11:50:45Z","timestamp":1678103445000},"page":"2202163","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":25,"title":["Eligibility criteria from pharmaceutical randomised controlled trials of idiopathic pulmonary fibrosis: a registry-based study"],"prefix":"10.1183","volume":"61","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-5434-9342","authenticated-orcid":false,"given":"Yet H.","family":"Khor","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Max","family":"Schulte","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1205-5511","authenticated-orcid":false,"given":"Kerri A.","family":"Johannson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Veronica","family":"Marcoux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jolene H.","family":"Fisher","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2497-9984","authenticated-orcid":false,"given":"Deborah","family":"Assayag","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Helene","family":"Manganas","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nasreen","family":"Khalil","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-3837-1467","authenticated-orcid":false,"given":"Martin","family":"Kolb","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christopher J.","family":"Ryerson","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"for the Austin ILD Registry and CARE-PF Investigators","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"name":"the ALLIANCE Study Group","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gerard","family":"Cox","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Charlene D.","family":"Fell","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrea S.","family":"Gershon","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Nicole","family":"Goh","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Andrew J.","family":"Halayko","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Stacey","family":"Lok","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Julie","family":"Morisset","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohsen","family":"Sadatsafavi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shane","family":"Shapera","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Teresa","family":"To","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Pearce G.","family":"Wilcox","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alyson W.","family":"Wong","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2023,3,1]]},"reference":[{"key":"2024102103123311000_61.5.2202163.1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(11)60405-4"},{"key":"2024102103123311000_61.5.2202163.2","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1402582"},{"key":"2024102103123311000_61.5.2202163.3","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1402584"},{"key":"2024102103123311000_61.5.2202163.4","doi-asserted-by":"publisher","DOI":"10.1183\/16000617.0158-2019"},{"key":"2024102103123311000_61.5.2202163.5","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.202202-0399ST"},{"key":"2024102103123311000_61.5.2202163.6","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1908681"},{"key":"2024102103123311000_61.5.2202163.7","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":"2024102103123311000_61.5.2202163.8","doi-asserted-by":"crossref","first-page":"3562923","DOI":"10.1155\/2016\/3562923","article-title":"The Canadian Registry for Pulmonary Fibrosis: design and rationale of a national pulmonary fibrosis registry","volume":"2016","author":"Ryerson","year":"2016","journal-title":"Can Respir J"},{"key":"2024102103123311000_61.5.2202163.9","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201807-1255ST"},{"key":"2024102103123311000_61.5.2202163.10","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.2009-040GL"},{"key":"2024102103123311000_61.5.2202163.11","doi-asserted-by":"crossref","first-page":"962","DOI":"10.1513\/AnnalsATS.202108-980OC","article-title":"Impact of concomitant medication burden on tolerability of disease-targeted therapy and survival in interstitial lung disease","volume":"19","author":"Khor","year":"2022","journal-title":"Ann Am Thorac Soc"},{"key":"2024102103123311000_61.5.2202163.12","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.02571-2021"},{"key":"2024102103123311000_61.5.2202163.13","doi-asserted-by":"crossref","first-page":"1841","DOI":"10.1001\/jama.2021.4956","article-title":"Effect of antimicrobial therapy on respiratory hospitalization or death in adults with idiopathic pulmonary fibrosis: the CleanUP-IPF randomized clinical trial","volume":"325","author":"Martinez","year":"2021","journal-title":"JAMA"},{"key":"2024102103123311000_61.5.2202163.14","doi-asserted-by":"crossref","first-page":"165","DOI":"10.1177\/1536867X1301300112","article-title":"Joint modeling of longitudinal and survival data","volume":"13","author":"Crowther","year":"2013","journal-title":"Stata J"},{"key":"2024102103123311000_61.5.2202163.15","doi-asserted-by":"publisher","DOI":"10.1093\/ije\/dyu262"},{"key":"2024102103123311000_61.5.2202163.16","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa042976"},{"key":"2024102103123311000_61.5.2202163.17","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa030511"},{"key":"2024102103123311000_61.5.2202163.18","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200404-571OC"},{"key":"2024102103123311000_61.5.2202163.19","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1843.2011.01955.x"},{"key":"2024102103123311000_61.5.2202163.20","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200906-0964OC"},{"key":"2024102103123311000_61.5.2202163.21","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.200705-732OC"},{"key":"2024102103123311000_61.5.2202163.22","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(09)60551-1"},{"key":"2024102103123311000_61.5.2202163.23","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00005209"},{"key":"2024102103123311000_61.5.2202163.24","doi-asserted-by":"publisher","DOI":"10.1111\/j.1440-1843.2012.02132.x"},{"key":"2024102103123311000_61.5.2202163.25","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201011-1874OC"},{"key":"2024102103123311000_61.5.2202163.26","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1002110"},{"key":"2024102103123311000_61.5.2202163.27","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-158-9-201305070-00003"},{"key":"2024102103123311000_61.5.2202163.28","unstructured":"ARTEMIS-PH \u2013 Study of Ambrisentan in Subjects with Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis (ARTEMIS-PH). 2009. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT00879229 Date last updated: 15 May 2014 ."},{"key":"2024102103123311000_61.5.2202163.29","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1401739"},{"key":"2024102103123311000_61.5.2202163.30","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201202-0314OC"},{"key":"2024102103123311000_61.5.2202163.31","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1113354"},{"key":"2024102103123311000_61.5.2202163.32","unstructured":"Study to Test the Validity of the Treatment of Idiopathic Pulmonary Fibrosis with Cotrimoxazole (TriSulfa-FPI). 2013. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT01777737 Date last updated: 14 November 2017 ."},{"key":"2024102103123311000_61.5.2202163.33","doi-asserted-by":"crossref","first-page":"22","DOI":"10.2174\/1874306402014010022","article-title":"Effects of nintedanib on quantitative lung fibrosis score in idiopathic pulmonary fibrosis","volume":"14","author":"Lancaster","year":"2020","journal-title":"Open Respir Med J"},{"key":"2024102103123311000_61.5.2202163.34","doi-asserted-by":"crossref","first-page":"2282","DOI":"10.1001\/jama.2020.22960","article-title":"Effect of co-trimoxazole (trimethoprim-sulfamethoxazole) vs placebo on death, lung transplant, or hospital admission in patients with moderate and severe idiopathic pulmonary fibrosis: the EME-TIPAC randomized clinical trial","volume":"324","author":"Wilson","year":"2020","journal-title":"JAMA"},{"key":"2024102103123311000_61.5.2202163.35","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.00348-2020"},{"key":"2024102103123311000_61.5.2202163.36","doi-asserted-by":"crossref","first-page":"771","DOI":"10.1016\/S2213-2600(19)30255-3","article-title":"Biomarkers of extracellular matrix turnover in patients with idiopathic pulmonary fibrosis given nintedanib (INMARK study): a randomised, placebo-controlled study","volume":"7","author":"Maher","year":"2019","journal-title":"Lancet Respir Med"},{"key":"2024102103123311000_61.5.2202163.37","doi-asserted-by":"crossref","first-page":"1722","DOI":"10.1056\/NEJMoa1811737","article-title":"Nintedanib plus sildenafil in patients with idiopathic pulmonary fibrosis","volume":"379","author":"Kolb","year":"2018","journal-title":"N Engl J Med"},{"key":"2024102103123311000_61.5.2202163.38","doi-asserted-by":"publisher","DOI":"10.1136\/bmjresp-2019-000422"},{"key":"2024102103123311000_61.5.2202163.39","unstructured":"Zephyrus I: Evaluation of Efficacy and Safety of Pamrevlumab in Patients with Idiopathic Pulmonary Fibrosis. 2019. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT03955146 Date last updated: 26 January 2023 ."},{"key":"2024102103123311000_61.5.2202163.40","unstructured":"Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants with Idiopathic Pulmonary Fibrosis (IPF). 2020. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04419558 Date last updated: 8 February 2023 ."},{"key":"2024102103123311000_61.5.2202163.41","unstructured":"Prospective Treatment Efficacy in IPF Using Genotype for Nac Selection (PRECISIONS) Trial (PRECISIONS). 2020. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04300920 Date last updated: 18 January 2023 ."},{"key":"2024102103123311000_61.5.2202163.42","unstructured":"A Study to Evaluate the Efficacy and Safety of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants with Idiopathic Pulmonary Fibrosis (STARSCAPE). 2020. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04552899 Date last updated: 10 February 2023 ."},{"key":"2024102103123311000_61.5.2202163.43","unstructured":"Study of Efficacy and Safety of Inhaled Treprostinil in Subjects with Idiopathic Pulmonary Fibrosis (TETON). 2021. www.clinicaltrials.gov\/ct2\/show\/NCT04708782 Date last updated: 16 February 2023 ."},{"key":"2024102103123311000_61.5.2202163.44","unstructured":"Treating People with Idiopathic Pulmonary Fibrosis with the Addition of Lansoprazole (TIPAL). 2021. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT04965298 Date last updated: 7 #November 2022 ."},{"key":"2024102103123311000_61.5.2202163.45","unstructured":"A Study to Find Out Whether BI 1015550 Improves Lung Function in People with Idiopathic Pulmonary Fibrosis (IPF). 2022. https:\/\/clinicaltrials.gov\/ct2\/show\/NCT05321069 Date last updated: 8 February 2023 ."},{"key":"2024102103123311000_61.5.2202163.46","doi-asserted-by":"crossref","first-page":"476","DOI":"10.1016\/S2213-2600(20)30554-3","article-title":"Pirfenidone in patients with progressive fibrotic interstitial lung diseases other than idiopathic pulmonary fibrosis (RELIEF): a double-blind, randomised, placebo-controlled, phase 2b trial","volume":"9","author":"Behr","year":"2021","journal-title":"Lancet Respir Med"},{"key":"2024102103123311000_61.5.2202163.47","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00185114"},{"key":"2024102103123311000_61.5.2202163.48","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.01504-2015"},{"key":"2024102103123311000_61.5.2202163.49","doi-asserted-by":"crossref","first-page":"271","DOI":"10.1164\/rccm.202110-2441OC","article-title":"Prognosis of patients with chronic obstructive pulmonary disease not eligible for major clinical trials","volume":"206","author":"\u00c7olak","year":"2022","journal-title":"Am J Respir Crit Care Med"}],"container-title":["European Respiratory Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1183\/13993003.02163-2022","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T06:21:21Z","timestamp":1740378081000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.ersnet.org\/lookup\/doi\/10.1183\/13993003.02163-2022"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2023,3,1]]},"references-count":49,"journal-issue":{"issue":"5","published-online":{"date-parts":[[2023,5,5]]},"published-print":{"date-parts":[[2023,5]]}},"alternative-id":["10.1183\/13993003.02163-2022"],"URL":"https:\/\/doi.org\/10.1183\/13993003.02163-2022","relation":{},"ISSN":["0903-1936","1399-3003"],"issn-type":[{"value":"0903-1936","type":"print"},{"value":"1399-3003","type":"electronic"}],"subject":[],"published":{"date-parts":[[2023,3,1]]}}}