{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,17]],"date-time":"2026-09-17T23:38:32Z","timestamp":1789688312988,"version":"4.0.1"},"reference-count":32,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2021,5,10]],"date-time":"2021-05-10T00:00:00Z","timestamp":1620604800000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2021,5,10]],"date-time":"2021-05-10T00:00:00Z","timestamp":1620604800000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"funder":[{"DOI":"10.13039\/501100002066","name":"GlaxoSmithKline foundation","doi-asserted-by":"publisher","award":["204471"],"award-info":[{"award-number":["204471"]}],"id":[{"id":"10.13039\/501100002066","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Respir Res"],"published-print":{"date-parts":[[2021,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>The OSMO study assessed the efficacy of switching to mepolizumab in patients with severe eosinophilic asthma that was uncontrolled whilst receiving omalizumab. The objective of this analysis was to assess the proportion of patients achieving pre-defined improvements in up to four efficacy outcomes and the relationship between patient baseline characteristics and treatment response.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>This was a post hoc analysis of OSMO study data (GSK ID:204471; ClinicalTrials.gov No. NCT02654145). Patients with severe eosinophilic asthma uncontrolled by high-dose inhaled corticosteroids, other controller(s) and omalizumab subcutaneously (\u2265\u20094\u00a0months) were switched to mepolizumab 100\u00a0mg administered subcutaneously. Endpoints included the proportion of responders\u2014i.e. patients achieving a pre-defined clinical improvement in\u2009\u2265\u20091 of the following outcomes: (1) Asthma Control Questionnaire (ACQ)-5 score (\u2265\u20090.5-points), (2) St George\u2019s Respiratory Questionnaire (SGRQ) total score (\u2265\u20094-points), (3) pre-bronchodilator forced expiratory volume in 1s (FEV<jats:sub>1<\/jats:sub>;\u2009\u2265\u2009100\u00a0mL), all at Week 32, and (4) annualised rate of clinically significant exacerbations (\u2265\u200950% reduction).<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>Of the 145 patients included, 94%, 83%, 63% and 31% were responders for\u2009\u2265\u20091,\u2009\u2265\u20092,\u2009\u2265\u20093 and 4 outcomes, respectively; 75% and 78% were ACQ-5 and SGRQ score responders, and 50% and 69% were FEV<jats:sub>1<\/jats:sub> and exacerbation responders. Subgroup analyses demonstrated improvements irrespective of baseline blood eosinophil count, prior omalizumab treatment regimen\/duration, comorbidities, prior exacerbation history, maintenance oral corticosteroid use, ACQ-5 and SGRQ scores, and body weight\/body mass index.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusions<\/jats:title>\n                <jats:p>After switching to mepolizumab, almost all patients with uncontrolled severe eosinophilic asthma on omalizumab achieved a beneficial response in\u2009\u2265\u20091 clinical outcome. Improvements were observed regardless of baseline characteristics.<\/jats:p>\n                <jats:p><jats:italic>Trial registration<\/jats:italic> This manuscript is a post hoc analysis of data from the OSMO study. ClinicalTrials.gov, NCT02654145. Registered January 13, 2016.<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s12931-021-01733-9","type":"journal-article","created":{"date-parts":[[2021,5,10]],"date-time":"2021-05-10T19:03:47Z","timestamp":1620673427000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":32,"title":["Benefit of switching to mepolizumab from omalizumab in severe eosinophilic asthma based on patient characteristics"],"prefix":"10.1186","volume":"22","clinical-trial-number":[{"clinical-trial-number":"nct02654145","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"Mark C.","family":"Liu","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bradley","family":"Chipps","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Xavier","family":"Munoz","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Gilles","family":"Devouassoux","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Miguel","family":"Bergna","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Steven G.","family":"Smith","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Robert G.","family":"Price","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dmitry V.","family":"Galkin","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jay","family":"Azmi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Dalal","family":"Mouneimne","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank C.","family":"Albers","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-2498-9859","authenticated-orcid":false,"given":"Kenneth R.","family":"Chapman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2021,5,10]]},"reference":[{"issue":"2","key":"1733_CR1","doi-asserted-by":"publisher","first-page":"343","DOI":"10.1183\/09031936.00202013","volume":"43","author":"KF Chung","year":"2014","unstructured":"Chung KF, Wenzel SE, Brozek JL, Bush A, Castro M, Sterk PJ, et al. International ERS\/ATS guidelines on definition, evaluation and treatment of severe asthma. Eur Respir J. 2014;43(2):343\u201373. https:\/\/doi.org\/10.1183\/09031936.00202013.","journal-title":"Eur Respir J"},{"issue":"5","key":"1733_CR2","doi-asserted-by":"publisher","first-page":"650","DOI":"10.1111\/j.1365-2222.2011.03929.x","volume":"42","author":"S Wenzel","year":"2012","unstructured":"Wenzel S. Severe asthma: from characteristics to phenotypes to endotypes. Clin Exp Allergy. 2012;42(5):650\u20138. https:\/\/doi.org\/10.1111\/j.1365-2222.2011.03929.x.","journal-title":"Clin Exp Allergy"},{"issue":"2","key":"1733_CR3","doi-asserted-by":"publisher","first-page":"152","DOI":"10.1080\/02770903.2017.1322611","volume":"55","author":"FC Albers","year":"2018","unstructured":"Albers FC, Mullerova H, Gunsoy NB, Shin JY, Nelsen LM, Bradford ES, et al. Biologic treatment eligibility for real-world patients with severe asthma: the IDEAL study. J Asthma. 2018;55(2):152\u201360. https:\/\/doi.org\/10.1080\/02770903.2017.1322611.","journal-title":"J Asthma"},{"key":"1733_CR4","doi-asserted-by":"publisher","first-page":"175346661880849","DOI":"10.1177\/1753466618808490","volume":"12","author":"R Emma","year":"2018","unstructured":"Emma R, Morjaria JB, Fuochi V, Polosa R, Caruso M. Mepolizumab in the management of severe eosinophilic asthma in adults: current evidence and practical experience. Ther Adv Respir Dis. 2018;12:1753466618808490. https:\/\/doi.org\/10.1177\/1753466618808490.","journal-title":"Ther Adv Respir Dis"},{"key":"1733_CR5","unstructured":"GSK UK. Mepolizumab (NUCALA) EU summary of product characteristics. 2019. https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/nucala-epar-product-information_en.pdf. Accessed 3 Nov 2020."},{"key":"1733_CR6","unstructured":"GSK. Mepolizumab (NUCALA) highlights of prescribing information. 2020. https:\/\/www.gsksource.com\/pharma\/content\/dam\/GlaxoSmithKline\/US\/en\/Prescribing_Information\/Nucala\/pdf\/NUCALA-PI-PIL.PDF. Accessed 6 Oct 2020."},{"issue":"13","key":"1733_CR7","doi-asserted-by":"publisher","first-page":"1189","DOI":"10.1056\/NEJMoa1403291","volume":"371","author":"EH Bel","year":"2014","unstructured":"Bel EH, Wenzel SE, Thompson PJ, Prazma CM, Keene ON, Yancey SW, et al. Oral glucocorticoid-sparing effect of mepolizumab in eosinophilic asthma. N Engl J Med. 2014;371(13):1189\u201397. https:\/\/doi.org\/10.1056\/NEJMoa1403291.","journal-title":"N Engl J Med"},{"issue":"13","key":"1733_CR8","doi-asserted-by":"publisher","first-page":"1198","DOI":"10.1056\/NEJMoa1403290","volume":"371","author":"HG Ortega","year":"2014","unstructured":"Ortega HG, Liu MC, Pavord ID, Brusselle GG, FitzGerald JM, Chetta A, et al. Mepolizumab treatment in patients with severe eosinophilic asthma. N Engl J Med. 2014;371(13):1198\u2013207. https:\/\/doi.org\/10.1056\/NEJMoa1403290.","journal-title":"N Engl J Med"},{"issue":"9842","key":"1733_CR9","doi-asserted-by":"publisher","first-page":"651","DOI":"10.1016\/s0140-6736(12)60988-x","volume":"380","author":"ID Pavord","year":"2012","unstructured":"Pavord ID, Korn S, Howarth P, Bleecker ER, Buhl R, Keene ON, et al. Mepolizumab for severe eosinophilic asthma (DREAM): a multicentre, double-blind, placebo-controlled trial. Lancet. 2012;380(9842):651\u20139. https:\/\/doi.org\/10.1016\/s0140-6736(12)60988-x.","journal-title":"Lancet"},{"issue":"5","key":"1733_CR10","doi-asserted-by":"publisher","first-page":"390","DOI":"10.1016\/s2213-2600(17)30125-x","volume":"5","author":"GL Chupp","year":"2017","unstructured":"Chupp GL, Bradford ES, Albers FC, Bratton DJ, Wang-Jairaj J, Nelsen LM, et al. Efficacy of mepolizumab add-on therapy on health-related quality of life and markers of asthma control in severe eosinophilic asthma (MUSCA): a randomised, double-blind, placebo-controlled, parallel-group, multicentre, phase 3b trial. Lancet Respir Med. 2017;5(5):390\u2013400. https:\/\/doi.org\/10.1016\/s2213-2600(17)30125-x.","journal-title":"Lancet Respir Med"},{"issue":"1","key":"1733_CR11","doi-asserted-by":"publisher","first-page":"169","DOI":"10.1186\/s12931-019-1134-7","volume":"20","author":"FC Albers","year":"2019","unstructured":"Albers FC, Papi A, Taill\u00e9 C, Bratton DJ, Bradford ES, Yancey SW, et al. Mepolizumab reduces exacerbations in patients with severe eosinophilic asthma, irrespective of body weight\/body mass index: meta-analysis of MENSA and MUSCA. Respir Res. 2019;20(1):169. https:\/\/doi.org\/10.1186\/s12931-019-1134-7.","journal-title":"Respir Res"},{"issue":"7","key":"1733_CR12","doi-asserted-by":"publisher","first-page":"549","DOI":"10.1016\/s2213-2600(16)30031-5","volume":"4","author":"HG Ortega","year":"2016","unstructured":"Ortega HG, Yancey SW, Mayer B, Gunsoy NB, Keene ON, Bleecker ER, et al. Severe eosinophilic asthma treated with mepolizumab stratified by baseline eosinophil thresholds: a secondary analysis of the DREAM and MENSA studies. Lancet Respir Med. 2016;4(7):549\u201356. https:\/\/doi.org\/10.1016\/s2213-2600(16)30031-5.","journal-title":"Lancet Respir Med"},{"key":"1733_CR13","doi-asserted-by":"publisher","DOI":"10.1111\/all.13850.10.1111\/all.13850","author":"KR Chapman","year":"2019","unstructured":"Chapman KR, Albers FC, Chipps B, Munoz X, Devouassoux G, Bergna M, et al. The clinical benefit of mepolizumab replacing omalizumab in uncontrolled severe eosinophilic asthma. Allergy. 2019. https:\/\/doi.org\/10.1111\/all.13850.10.1111\/all.13850.","journal-title":"Allergy"},{"issue":"AB94","key":"1733_CR14","first-page":"A283","volume":"143","author":"C Prazma","year":"2019","unstructured":"Prazma C, Albers F, Mallett S, Llanos-Ackert J, Yancey S. Mepolizumab improves patient outcomes and reduces exacerbations in severe asthma patients with comorbid upper airways disease. J Allergy Clin Immunol. 2019;143(AB94):A283.","journal-title":"J Allergy Clin Immunol."},{"key":"1733_CR15","unstructured":"FDA. Xolair (omalizumab) highlights of prescribing information. 2003. https:\/\/www.accessdata.fda.gov\/drugsatfda_docs\/label\/2016\/103976s5225lbl.pdf. Accessed 3 Nov 2020."},{"issue":"9","key":"1733_CR16","doi-asserted-by":"publisher","first-page":"573","DOI":"10.7326\/0003-4819-154-9-201105030-00002","volume":"154","author":"NA Hanania","year":"2011","unstructured":"Hanania NA, Alpan O, Hamilos DL, Condemi JJ, Reyes-Rivera I, Zhu J, et al. Omalizumab in severe allergic asthma inadequately controlled with standard therapy: a randomized trial. Ann Intern Med. 2011;154(9):573\u201382. https:\/\/doi.org\/10.7326\/0003-4819-154-9-201105030-00002.","journal-title":"Ann Intern Med"},{"issue":"4","key":"1733_CR17","doi-asserted-by":"publisher","first-page":"632","DOI":"10.1111\/j.1365-2222.2004.1916.x","volume":"34","author":"ST Holgate","year":"2004","unstructured":"Holgate ST, Chuchalin AG, Hebert J, Lotvall J, Persson GB, Chung KF, et al. Efficacy and safety of a recombinant anti-immunoglobulin E antibody (omalizumab) in severe allergic asthma. Clin Exp Allergy. 2004;34(4):632\u20138. https:\/\/doi.org\/10.1111\/j.1365-2222.2004.1916.x.","journal-title":"Clin Exp Allergy"},{"issue":"3","key":"1733_CR18","doi-asserted-by":"publisher","first-page":"309","DOI":"10.1111\/j.1398-9995.2004.00772.x","volume":"60","author":"M Humbert","year":"2005","unstructured":"Humbert M, Beasley R, Ayres J, Slavin R, Hebert J, Bousquet J, et al. Benefits of omalizumab as add-on therapy in patients with severe persistent asthma who are inadequately controlled despite best available therapy (GINA 2002 step 4 treatment): INNOVATE. Allergy. 2005;60(3):309\u201316. https:\/\/doi.org\/10.1111\/j.1398-9995.2004.00772.x.","journal-title":"Allergy"},{"key":"1733_CR19","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.02523-2017","author":"M Humbert","year":"2018","unstructured":"Humbert M, Taill\u00e9 C, Mala L, Le Gros V, Just J, Molimard M. Omalizumab effectiveness in patients with severe allergic asthma according to blood eosinophil count: the STELLAIR study. Eur Respir J. 2018. https:\/\/doi.org\/10.1183\/13993003.02523-2017.","journal-title":"Eur Respir J."},{"key":"1733_CR20","unstructured":"Global Initiative for Asthma (GINA). Global strategy for asthma management and prevention. 2020. https:\/\/ginasthma.org\/wp-content\/uploads\/2020\/04\/GINA-2020-full-report_-final-_wms.pdf. Accessed 13 May 2020."},{"issue":"3","key":"1733_CR21","doi-asserted-by":"publisher","first-page":"398","DOI":"10.1183\/09031936.02.00063702","volume":"19","author":"PW Jones","year":"2002","unstructured":"Jones PW. Interpreting thresholds for a clinically significant change in health status in asthma and COPD. Eur Respir J. 2002;19(3):398\u2013404. https:\/\/doi.org\/10.1183\/09031936.02.00063702.","journal-title":"Eur Respir J"},{"issue":"5","key":"1733_CR22","doi-asserted-by":"publisher","first-page":"553","DOI":"10.1016\/j.rmed.2004.10.008","volume":"99","author":"EF Juniper","year":"2005","unstructured":"Juniper EF, Svensson K, M\u00f6rk AC, St\u00e5hl E. Measurement properties and interpretation of three shortened versions of the asthma control questionnaire. Respir Med. 2005;99(5):553\u20138. https:\/\/doi.org\/10.1016\/j.rmed.2004.10.008.","journal-title":"Respir Med"},{"issue":"3 Suppl","key":"1733_CR23","doi-asserted-by":"publisher","first-page":"S65","DOI":"10.1016\/j.jaci.2011.12.986","volume":"129","author":"RS Tepper","year":"2012","unstructured":"Tepper RS, Wise RS, Covar R, Irvin CG, Kercsmar CM, Kraft M, et al. Asthma outcomes: pulmonary physiology. J Allergy Clin Immunol. 2012;129(3 Suppl):S65-87. https:\/\/doi.org\/10.1016\/j.jaci.2011.12.986.","journal-title":"J Allergy Clin Immunol"},{"issue":"11","key":"1733_CR24","doi-asserted-by":"publisher","first-page":"849","DOI":"10.1016\/s2213-2600(15)00367-7","volume":"3","author":"DB Price","year":"2015","unstructured":"Price DB, Rigazio A, Campbell JD, Bleecker ER, Corrigan CJ, Thomas M, et al. Blood eosinophil count and prospective annual asthma disease burden: a UK cohort study. Lancet Respir Med. 2015;3(11):849\u201358. https:\/\/doi.org\/10.1016\/s2213-2600(15)00367-7.","journal-title":"Lancet Respir Med"},{"issue":"1","key":"1733_CR25","doi-asserted-by":"publisher","first-page":"74","DOI":"10.1186\/s12890-017-0409-3","volume":"17","author":"RY Suruki","year":"2017","unstructured":"Suruki RY, Daugherty JB, Boudiaf N, Albers FC. The frequency of asthma exacerbations and healthcare utilization in patients with asthma from the UK and USA. BMC Pulm Med. 2017;17(1):74. https:\/\/doi.org\/10.1186\/s12890-017-0409-3.","journal-title":"BMC Pulm Med"},{"issue":"2","key":"1733_CR26","doi-asserted-by":"publisher","first-page":"272","DOI":"10.1111\/j.1440-1843.2006.00964.x","volume":"12","author":"E Ceylan","year":"2007","unstructured":"Ceylan E, Gencer M, San I. Nasal polyps and the severity of asthma. Respirology. 2007;12(2):272\u20136. https:\/\/doi.org\/10.1111\/j.1440-1843.2006.00964.x.","journal-title":"Respirology"},{"issue":"1","key":"1733_CR27","doi-asserted-by":"publisher","first-page":"33","DOI":"10.1186\/s13223-015-0100-2","volume":"11","author":"S Baba","year":"2015","unstructured":"Baba S, Kagoya R, Kondo K, Suzukawa M, Ohta K, Yamasoba T. T-cell phenotypes in chronic rhinosinusitis with nasal polyps in Japanese patients. Allergy Asthma Clin Immunol. 2015;11(1):33.","journal-title":"Allergy Asthma Clin Immunol"},{"key":"1733_CR28","doi-asserted-by":"publisher","first-page":"49","DOI":"10.3389\/fmed.2018.00049","volume":"5","author":"F Roufosse","year":"2018","unstructured":"Roufosse F. Targeting the interleukin-5 pathway for treatment of eosinophilic conditions other than asthma. Front Med. 2018;5:49.","journal-title":"Front Med"},{"issue":"1","key":"1733_CR29","doi-asserted-by":"publisher","first-page":"1","DOI":"10.1097\/ACI.0000000000000588","volume":"20","author":"G Ryu","year":"2020","unstructured":"Ryu G, Kim DW. Th2 inflammatory responses in the development of nasal polyps and chronic rhinosinusitis. Curr Opin Allergy Clin Immunol. 2020;20(1):1\u20138.","journal-title":"Curr Opin Allergy Clin Immunol"},{"key":"1733_CR30","doi-asserted-by":"publisher","first-page":"3137","DOI":"10.2147\/DDDT.S150656","volume":"11","author":"C Pelaia","year":"2017","unstructured":"Pelaia C, Vatrella A, Busceti MT, Gallelli L, Terracciano R, Savino R, et al. Severe eosinophilic asthma: from the pathogenic role of interleukin-5 to the therapeutic action of mepolizumab. Drug Des Devel Ther. 2017;11:3137.","journal-title":"Drug Des Devel Ther"},{"key":"1733_CR31","doi-asserted-by":"publisher","DOI":"10.1183\/13993003.00936-2018","author":"ER Bleecker","year":"2018","unstructured":"Bleecker ER, Wechsler ME, FitzGerald JM, Menzies-Gow A, Wu Y, Hirsch I, et al. Baseline patient factors impact on the clinical efficacy of benralizumab for severe asthma. Eur Respir J. 2018. https:\/\/doi.org\/10.1183\/13993003.00936-2018.","journal-title":"Eur Respir J."},{"issue":"Suppl 64","key":"1733_CR32","doi-asserted-by":"publisher","first-page":"4616","DOI":"10.1183\/13993003.congress-2020","volume":"56","author":"C Hopkins","year":"2020","unstructured":"Hopkins C, Bachert C, Fokkens W, Desrosiers M, Wagenmann M, Lee S, et al. Add-on mepolizumab for chronic rhinosinusitis with nasal polyps: SYNAPSE study. Eur Respir J. 2020;56(Suppl 64):4616. https:\/\/doi.org\/10.1183\/13993003.congress-2020.","journal-title":"Eur Respir J"}],"container-title":["Respiratory Research"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12931-021-01733-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s12931-021-01733-9\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s12931-021-01733-9.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2021,8,10]],"date-time":"2021-08-10T16:35:42Z","timestamp":1628613342000},"score":1,"resource":{"primary":{"URL":"https:\/\/respiratory-research.biomedcentral.com\/articles\/10.1186\/s12931-021-01733-9"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2021,5,10]]},"references-count":32,"journal-issue":{"issue":"1","published-print":{"date-parts":[[2021,12]]}},"alternative-id":["1733"],"URL":"https:\/\/doi.org\/10.1186\/s12931-021-01733-9","relation":{},"ISSN":["1465-993X"],"issn-type":[{"value":"1465-993X","type":"electronic"}],"subject":[],"published":{"date-parts":[[2021,5,10]]},"assertion":[{"value":"25 February 2021","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"25 April 2021","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"10 May 2021","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The OSMO study was conducted in accordance with International Conference for Harmonization Good Clinical Practice, applicable country\u2010specific requirements and ethical principles outlined in the Declaration of Helsinki. All patients provided written informed consent prior to any study\u2010related activities. The study was approved by local ethics review boards of the participating sites.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics and approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"SGS, JA, DM, and RGP are all employees of GSK and hold stocks\/shares in GSK. FCA is a former employee of GSK and holds GSK stocks\/shares and is currently employed by Avillion US, Inc. DVG is a former employee of GSK and holds GSK stock\/shares and is currently employed by Chiesi USA; KRC has received consulting fees from AstraZeneca, Boehringer Ingelheim, CSL Behring, GSK, Grifols, Kamada, Novartis, Roche, and Sanofi Regeneron; has undertaken research funded by Amgen, AstraZeneca, Boehringer Ingelheim, CSL Behring, GSK, Grifols, Kamada, Novartis, Roche and Sanofi; has participated in continuing medical education activities sponsored in whole or in part by AstraZeneca, Boehringer Ingelheim, GSK, Grifols, Novartis and Teva. KRC is also participating in research funded by the Canadian Institutes of Health Research. GD has received personal fees or research grants from Novartis Pharma, AstraZeneca, GSK, Boehringer Ingelheim, Mundi Pharma, Vivisol, Sanofi, Chiesi, ALK, Teva, MSD and AGIR \u00e0 Dom; has participated in CME activities sponsored by GSK, AstraZeneca, Novartis Pharma, Chiesi, MSD, Takeda, AGIR \u00e0 Dom, Orkyn, Mundi Pharma, ALK, Stallergenes, Boehringer Ingelheim and Teva; is participating in research funded by GSK, ALK, AstraZeneca, Novartis Pharma, Boehringer Ingelheim, Vitalair, AB science, Amgen, Lilly, Sanofi, Roche and Teva. MB has received personal fees or research grants from AstraZeneca, Novartis, GSK, Boehringer Ingelheim, and Sanofi. MCL has participated in advisory board meetings for GSK, Gossamer Bio and AstraZeneca, and has received research grants from GSK, and Gossamer Bio. BC is an advisor for, has received consultancy fees from, and is on the speaker's bureau AstraZeneca, Boehringer Ingelheim, Genentech, GlaxoSmithKline, Novartis, Regeneron and Sanofi-Genzyme. XM has received fees as a speaker, scientific advisor or participant of clinical studies for AstraZeneca, Boehringer Ingelheim, Chiesi, Faes, GSK, Menarini, MundiPharma, Novartis and Teva.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"144"}}