{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,14]],"date-time":"2026-09-14T22:36:06Z","timestamp":1789425366429,"version":"build-2803163510"},"reference-count":30,"publisher":"European Respiratory Society (ERS)","issue":"3","funder":[{"name":"Pearl \u2013 a member of the AstraZeneca Group"}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2018,8,12]]},"published-print":{"date-parts":[[2018,9]]},"abstract":"<jats:p>TELOS compared budesonide (BD)\/formoterol fumarate dihydrate (FF) metered dose inhaler (BFF MDI), formulated using innovative co-suspension delivery technology that enables consistent aerosol performance, with its monocomponents and budesonide\/formoterol fumarate dihydrate dry powder inhaler (DPI) in patients with moderate to very severe chronic obstructive pulmonary disease (COPD), without a requirement for an exacerbation history.<\/jats:p><jats:p>In this phase III, double-blind, parallel-group, 24-week study (<jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT02766608\">NCT02766608<\/jats:ext-link>), patients were randomised to BFF MDI 320\/10\u2005\u00b5g (n=664), BFF MDI 160\/10\u2005\u00b5g (n=649), FF MDI 10\u2005\u00b5g (n=648), BD MDI 320\u2005\u00b5g (n=209) or open-label budesonide\/formoterol DPI 400\/12\u2005\u00b5g (n=219). Primary end-points were change from baseline in morning pre-dose trough forced expiratory volume in 1\u2005s (FEV<jats:sub>1<\/jats:sub>) and FEV<jats:sub>1<\/jats:sub>area under the curve from 0\u20134\u2005h (AUC<jats:sub>0\u20134<\/jats:sub>). Time to first and rate of moderate\/severe exacerbations were assessed.<\/jats:p><jats:p>BFF MDI 320\/10\u2005\u00b5g improved pre-dose trough FEV<jats:sub>1<\/jats:sub><jats:italic>versus<\/jats:italic>FF MDI (least squares mean (LSM) 39\u2005mL; p=0.0018), and BFF MDI 320\/10\u2005\u00b5g and 160\/10\u2005\u00b5g improved FEV<jats:sub>1<\/jats:sub>AUC<jats:sub>0\u20134<\/jats:sub><jats:italic>versus<\/jats:italic>BD MDI (LSM 173\u2005mL and 157\u2005mL, respectively; both p&lt;0.0001) at week 24. BFF MDI 320\/10\u2005\u00b5g and 160\/10\u2005\u00b5g improved time to first and rate of moderate\/severe exacerbations<jats:italic>versus<\/jats:italic>FF MDI. Treatments were well tolerated, with pneumonia incidence ranging from 0.5\u20131.4%.<\/jats:p><jats:p>BFF MDI improved lung function<jats:italic>versus<\/jats:italic>monocomponents and exacerbations<jats:italic>versus<\/jats:italic>FF MDI in patients with moderate to very severe COPD.<\/jats:p>","DOI":"10.1183\/13993003.01334-2018","type":"journal-article","created":{"date-parts":[[2018,9,16]],"date-time":"2018-09-16T12:55:11Z","timestamp":1537102511000},"page":"1801334","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":22,"title":["Budesonide\/formoterol MDI with co-suspension delivery technology in COPD: the TELOS study"],"prefix":"10.1183","volume":"52","author":[{"given":"Gary 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