{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,30]],"date-time":"2026-09-30T18:20:06Z","timestamp":1790792406297,"version":"4.1.0"},"reference-count":31,"publisher":"European Respiratory Society (ERS)","issue":"2","license":[{"start":{"date-parts":[[2020,4,1]],"date-time":"2020-04-01T00:00:00Z","timestamp":1585699200000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["ERJ Open Res"],"accepted":{"date-parts":[[2020,1,19]]},"published-print":{"date-parts":[[2020,4]]},"abstract":"<jats:p>Inhaled corticosteroid\/long-acting \u03b2<jats:sub>2<\/jats:sub>-agonist combination therapy is a recommended treatment option for patients with chronic obstructive pulmonary disease (COPD) and increased exacerbation risk, particularly those with elevated blood eosinophil levels. SOPHOS (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02727660\">NCT02727660<\/jats:ext-link>) evaluated the efficacy and safety of two doses of budesonide\/formoterol fumarate dihydrate metered dose inhaler (BFF MDI)<jats:italic>versus<\/jats:italic>formoterol fumarate dihydrate (FF) MDI, each delivered using co-suspension delivery technology, in patients with moderate-to-very severe COPD and a history of exacerbations.<\/jats:p><jats:p>In this phase 3, randomised, double-blind, parallel-group, 12\u201352-week, variable length study, patients received twice-daily BFF MDI 320\/10\u2005\u00b5g or 160\/10\u2005\u00b5g, or FF MDI 10\u2005\u00b5g. The primary endpoint was change from baseline in morning pre-dose trough forced expiratory volume in 1 s (FEV<jats:sub>1<\/jats:sub>) at week 12. Secondary and other endpoints included assessments of moderate\/severe COPD exacerbations and safety.<\/jats:p><jats:p>The primary analysis (modified intent-to-treat) population included 1843 patients (BFF MDI 320\/10\u2005\u00b5g, n=619; BFF MDI 160\/10\u2005\u00b5g, n=617; and FF MDI, n=607). BFF MDI 320\/10\u2005\u00b5g and 160\/10\u2005\u00b5g improved morning pre-dose trough FEV<jats:sub>1<\/jats:sub>at week 12<jats:italic>versus<\/jats:italic>FF MDI (least squares mean differences 34\u2005mL [p=0.0081] and 32\u2005mL [p=0.0134], respectively), increased time to first exacerbation (hazard ratios 0.827 [p=0.0441] and 0.803 [p=0.0198], respectively) and reduced exacerbation rate (rate ratios 0.67 [p=0.0001] and 0.71 [p=0.0010], respectively). Lung function and exacerbation benefits were driven by patients with blood eosinophil counts \u2265150\u2005cells\u00b7mm<jats:sup>\u22123<\/jats:sup>. The incidence of adverse events was similar, and pneumonia rates were low (\u22642.4%) across treatments.<\/jats:p><jats:p>SOPHOS demonstrated the efficacy and tolerability of BFF MDI 320\/10\u2005\u00b5g and 160\/10\u2005\u00b5g in patients with moderate-to-very severe COPD at increased risk of exacerbations.<\/jats:p>","DOI":"10.1183\/23120541.00187-2019","type":"journal-article","created":{"date-parts":[[2020,4,27]],"date-time":"2020-04-27T16:53:48Z","timestamp":1588006428000},"page":"00187-2019","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":8,"title":["Efficacy and safety of two doses of budesonide\/formoterol fumarate metered dose inhaler in COPD"],"prefix":"10.1183","volume":"6","author":[{"given":"Nicola A.","family":"Hanania","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-6924-4500","authenticated-orcid":false,"given":"Alberto","family":"Papi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Antonio","family":"Anzueto","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fernando J.","family":"Martinez","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kimberly A.","family":"Rossman","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Christy S.","family":"Cappelletti","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Elizabeth A.","family":"Duncan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jack S.","family":"Nyberg","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul M.","family":"Dorinsky","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"81","published-online":{"date-parts":[[2020,4,27]]},"reference":[{"key":"2024101707520003000_6.2.00187-2019.1","unstructured":"Global Initiative for Chronic Obstructive Lung Disease . 2019 Report: Global Strategy for the Diagnosis, Management and Prevention of COPD . https:\/\/goldcopd.org. 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