{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,3,21]],"date-time":"2026-03-21T19:35:54Z","timestamp":1774121754584,"version":"3.50.1"},"reference-count":36,"publisher":"BMJ","issue":"1","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2011,12,9]]},"published-print":{"date-parts":[[2012]]},"abstract":"<jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Fluticasone furoate\/vilanterol (FF\/VI) is a novel once-daily (OD) inhaled corticosteroid\/long-acting \u03b2\n                      <jats:sub>2<\/jats:sub>\n                      agonist combination in development for chronic obstructive pulmonary disease (COPD) and asthma.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial design<\/jats:title>\n                    <jats:p>A multicentre, randomised, double-blind, parallel-group, placebo-controlled study.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      Participants were patients with moderate-to-severe COPD treated with placebo or FF\/VI 400\/25\u2005\u03bcg OD for 4\u2005weeks. Study objectives were to assess the safety and efficacy of FF\/VI 400\/25\u2005\u03bcg OD administered for 4\u2005weeks via a novel dry powder inhaler. Co-primary end points were change from baseline in weighted mean (wm) heart rate 0\u20134\u2005h postdose at day 28 and the incidence of adverse events (AEs). Secondary end points included change from baseline in trough forced expiratory volume in one second (FEV\n                      <jats:sub>1<\/jats:sub>\n                      ) (23\u201324\u2005h postdose; day 29) and wm FEV\n                      <jats:sub>1<\/jats:sub>\n                      (0\u20134\u2005h postdose; day 28). Patients were randomised to receive FF\/VI 400\/25\u2005\u03bcg or placebo in a 2:1 ratio; all patients and investigators were blinded to active or placebo treatment.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      60 patients (mean age 64\u2005years) were randomised (FF\/VI: n=40; placebo: n=20), and all contributed data to the analysis. Mean screening post-bronchodilator FEV\n                      <jats:sub>1<\/jats:sub>\n                      per cent predicted was comparable between groups (FF\/VI: 58.5%; placebo: 60.1%). The wm heart rate 0\u20134\u2005h postdose was similar between groups (difference: 0.6\u2005beats per minute; 95% CI \u22123.9 to 5.1). More on-treatment AEs were reported in the FF\/VI group (68%) compared with the placebo group (50%). The most common drug-related AEs in the FF\/VI group were oral candidiasis (8%) and dysphonia (5%). There were no clinically relevant effects on laboratory values, including glucose and potassium, or on vital signs or ECGs\/Holters. The FF\/VI group had statistically greater improvements compared with placebo in trough FEV\n                      <jats:sub>1<\/jats:sub>\n                      (mean difference 183\u2005ml) and 0\u20134\u2005h postdose wm FEV\n                      <jats:sub>1<\/jats:sub>\n                      (mean difference 236\u2005ml).\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>FF\/VI has a good safety and tolerability profile and improves lung function compared with placebo in patients with COPD.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>\n                      clinical trials.gov\u2014\n                      <jats:ext-link xmlns:xlink=\"http:\/\/www.w3.org\/1999\/xlink\" ext-link-type=\"clintrialgov\" xlink:href=\"NCT00731822\">NCT00731822<\/jats:ext-link>\n                      .\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2011-000370","type":"journal-article","created":{"date-parts":[[2012,1,20]],"date-time":"2012-01-20T21:41:08Z","timestamp":1327095668000},"page":"e000370","source":"Crossref","is-referenced-by-count":31,"title":["Efficacy and safety of 4\u2005weeks' treatment with combined fluticasone furoate\/vilanterol in a single inhaler given once daily in COPD: a placebo-controlled randomised trial"],"prefix":"10.1136","volume":"2","clinical-trial-number":[{"clinical-trial-number":"nct00731822","registry":"10.18810\/clinical-trials-gov"},{"clinical-trial-number":"nct00731822","registry":"10.18810\/clinical-trials-gov"}],"author":[{"given":"J","family":"L\u00f6tvall","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"P S","family":"Bakke","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L","family":"Bjermer","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"S","family":"Steinshamn","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C","family":"Scott-Wilson","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"C","family":"Crim","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"L","family":"Sanford","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"B","family":"Haumann","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"239","published-online":{"date-parts":[[2012,1,19]]},"reference":[{"key":"2025121411175269000_2.1.e000370.1","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.06.00024505"},{"key":"2025121411175269000_2.1.e000370.2","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.06.00025805"},{"key":"2025121411175269000_2.1.e000370.3","doi-asserted-by":"publisher","DOI":"10.1371\/journal.pmed.0030442"},{"key":"2025121411175269000_2.1.e000370.4","unstructured":"Global Initiative for Chronic Obstructive Lung Disease (GOLD). 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