{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,14]],"date-time":"2026-05-14T19:18:11Z","timestamp":1778786291008,"version":"3.51.4"},"reference-count":23,"publisher":"European Respiratory Society (ERS)","issue":"4","funder":[{"DOI":"10.13039\/100004325","name":"AstraZeneca","doi-asserted-by":"publisher","id":[{"id":"10.13039\/100004325","id-type":"DOI","asserted-by":"publisher"}]},{"name":"Almirall"}],"content-domain":{"domain":["publications.ersnet.org"],"crossmark-restriction":true},"short-container-title":["Eur Respir J"],"accepted":{"date-parts":[[2016,6,3]]},"published-print":{"date-parts":[[2016,10]]},"abstract":"<jats:p>The efficacy and safety of twice-daily aclidinium bromide\/formoterol fumarate was compared with that of salmeterol\/fluticasone propionate in patients with stable, moderate-to-severe chronic obstructive pulmonary disease (COPD).<\/jats:p><jats:p>AFFIRM COPD (Aclidinium and Formoterol Findings in Respiratory Medicine COPD) was a 24-week, double-blind, double-dummy, active-controlled study. Patients were randomised (1:1) to aclidinium\/formoterol 400\/12\u2005\u00b5g twice-daily<jats:italic>via<\/jats:italic>Genuair\/Pressair or salmeterol\/fluticasone 50\/500\u2005\u00b5g twice-daily<jats:italic>via<\/jats:italic>Accuhaler. The primary end-point was peak forced expiratory volume in 1\u2005s (FEV<jats:sub>1<\/jats:sub>) at week 24. Other end-points included Transition Dyspnoea Index (TDI) focal score at week 24, TDI and St George's Respiratory Questionnaire (SGRQ) responders, COPD Assessment Test and SGRQ scores, assessment of COPD symptoms and exacerbations, use of reliever medication, and device preference. Adverse events were monitored throughout.<\/jats:p><jats:p>In total, 933 patients were eligible (mean age 63.4\u2005years, 65.1% male). Aclidinium\/formoterol was superior to salmeterol\/fluticasone in peak FEV<jats:sub>1<\/jats:sub>and noninferior in TDI. Health status and reduction in exacerbation risk were similar in both groups. While both treatments were well tolerated, pneumonia occurred less frequently with aclidinium\/formoterol than salmeterol\/fluticasone.<\/jats:p><jats:p>In stable COPD, aclidinium\/formoterol significantly improved bronchodilation<jats:italic>versus<\/jats:italic>salmeterol\/fluticasone, with equivalent benefits in symptom control and reduction in exacerbation risk. Both treatments were well tolerated and treatment-related adverse events were less common with aclidinium\/formoterol.<\/jats:p>","DOI":"10.1183\/13993003.00216-2016","type":"journal-article","created":{"date-parts":[[2016,8,5]],"date-time":"2016-08-05T02:43:31Z","timestamp":1470365011000},"page":"1030-1039","update-policy":"https:\/\/doi.org\/10.1183\/ers-crossmark-policy","source":"Crossref","is-referenced-by-count":70,"title":["Efficacy and safety of aclidinium\/formoterol<i>versus<\/i>salmeterol\/fluticasone: a phase 3 COPD study"],"prefix":"10.1183","volume":"48","author":[{"given":"Claus","family":"Vogelmeier","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pier Luigi","family":"Paggiaro","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jordi","family":"Dorca","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Pawel","family":"Sliwinski","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Marcel","family":"Mallet","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne-Marie","family":"Kirsten","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Jutta","family":"Beier","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Beatriz","family":"Seoane","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rosa Maria","family":"Segarra","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Anne","family":"Leselbaum","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"81","published-online":{"date-parts":[[2016,8,4]]},"reference":[{"key":"2024102100091674000_48.4.1030.1","unstructured":"Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease. 2015. Available from: www.goldcopd.org"},{"key":"2024102100091674000_48.4.1030.2","doi-asserted-by":"publisher","DOI":"10.1016\/j.ddstr.2006.09.009"},{"key":"2024102100091674000_48.4.1030.3","doi-asserted-by":"publisher","DOI":"10.1111\/j.1476-5381.2011.01216.x"},{"key":"2024102100091674000_48.4.1030.4","doi-asserted-by":"publisher","DOI":"10.1124\/pr.111.004580"},{"key":"2024102100091674000_48.4.1030.5","first-page":"CD010844","article-title":"Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis","volume":"3","author":"Kew","year":"2014","journal-title":"Cochrane Database Syst Rev"},{"key":"2024102100091674000_48.4.1030.6","doi-asserted-by":"publisher","DOI":"10.1016\/j.pupt.2014.10.006"},{"key":"2024102100091674000_48.4.1030.7","doi-asserted-by":"publisher","DOI":"10.3109\/15412555.2014.995288"},{"key":"2024102100091674000_48.4.1030.8","unstructured":"European Medicines Agency. Duaklir Genuair. www.ema.europa.eu\/ema\/index.jsp?curl=pages\/medicines\/human\/medicines\/003745\/human_med_001811.jsp&mid=WC0b01ac058001d124 Date last updated: June 21, 2016. Date last accessed: July 15, 2016."},{"key":"2024102100091674000_48.4.1030.9","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2466-14-178"},{"key":"2024102100091674000_48.4.1030.10","doi-asserted-by":"publisher","DOI":"10.1186\/s12931-014-0123-0"},{"key":"2024102100091674000_48.4.1030.11","doi-asserted-by":"publisher","DOI":"10.1186\/s12931-015-0250-2"},{"key":"2024102100091674000_48.4.1030.12","doi-asserted-by":"publisher","DOI":"10.1111\/j.1524-4733.2010.00772.x"},{"key":"2024102100091674000_48.4.1030.13","doi-asserted-by":"publisher","DOI":"10.1164\/rccm.201005-0762OC"},{"key":"2024102100091674000_48.4.1030.14","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-11-104"},{"key":"2024102100091674000_48.4.1030.15","first-page":"475","article-title":"Evaluation of the psychometric properties of the Nighttime Symptoms of COPD Instrument","volume":"10","author":"Mocarski","year":"2015","journal-title":"Int J Chron Obstruct Pulmon Dis"},{"key":"2024102100091674000_48.4.1030.16","doi-asserted-by":"crossref","first-page":"A179","DOI":"10.1016\/j.jval.2014.03.1044","article-title":"Evaluation of the psychometric properties of the early morning symptoms of COPD instrument (EMSCI","volume":"17","author":"Mocarski","year":"2014","journal-title":"Value Health"},{"key":"2024102100091674000_48.4.1030.17","first-page":"1905","article-title":"ICH harmonised tripartite guideline statistical principles for clinical trials E9","volume":"18","author":"International Conference on Harmonisation E9 Expert Working Group","year":"1999","journal-title":"Stat Med"},{"key":"2024102100091674000_48.4.1030.18","doi-asserted-by":"publisher","DOI":"10.1016\/S2213-2600(12)70052-8"},{"key":"2024102100091674000_48.4.1030.19","first-page":"1015","article-title":"LANTERN: a randomized study of QVA149 versus salmeterol\/fluticasone combination in patients with COPD","volume":"10","author":"Zhong","year":"2015","journal-title":"Int J Chron Obstruct Pulmon Dis"},{"key":"2024102100091674000_48.4.1030.20","doi-asserted-by":"publisher","DOI":"10.1016\/j.rmed.2015.04.018"},{"key":"2024102100091674000_48.4.1030.21","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00025214"},{"key":"2024102100091674000_48.4.1030.22","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.00125612"},{"key":"2024102100091674000_48.4.1030.23","doi-asserted-by":"publisher","DOI":"10.1056\/NEJMoa1407154"}],"container-title":["European Respiratory Journal"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1183\/13993003.00216-2016","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,2,24]],"date-time":"2025-02-24T06:35:43Z","timestamp":1740378943000},"score":1,"resource":{"primary":{"URL":"https:\/\/publications.ersnet.org\/lookup\/doi\/10.1183\/13993003.00216-2016"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2016,8,4]]},"references-count":23,"journal-issue":{"issue":"4","published-online":{"date-parts":[[2016,9,30]]},"published-print":{"date-parts":[[2016,10]]}},"alternative-id":["10.1183\/13993003.00216-2016"],"URL":"https:\/\/doi.org\/10.1183\/13993003.00216-2016","relation":{},"ISSN":["0903-1936","1399-3003"],"issn-type":[{"value":"0903-1936","type":"print"},{"value":"1399-3003","type":"electronic"}],"subject":[],"published":{"date-parts":[[2016,8,4]]}}}