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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/advagg_css\/css__ce2QY63WIanKyr8eSq7eavr1XQRRmFD6ZSmwpyJi8lM__zXwFqpqmxrZOXXcd_TpBQpjuELbmIP9wBR5UuTDWAO4__YJWWMMdfCJuAFm5cUEp88OsodhO3ZA-2lzRfoBsSlk4.css\u0022 media=\u0022all\u0022 \/\u003E\n\u003Clink rel=\u0027stylesheet\u0027 type=\u0027text\/css\u0027 href=\u0027\/sites\/all\/modules\/contrib\/panels\/plugins\/layouts\/onecol\/onecol.css\u0027 \/\u003E\u003C\/head\u003E\u003Cbody\u003E\u003Cdiv class=\u0022panels-ajax-tab-panel panels-ajax-tab-panel-sageoa-tab-art\u0022\u003E\u003Cdiv class=\u0022panel-display panel-1col clearfix\u0022 \u003E\n  \u003Cdiv class=\u0022panel-panel panel-col\u0022\u003E\n    \u003Cdiv\u003E\u003Cdiv class=\u0022panel-pane pane-highwire-markup\u0022 \u003E\n  \n      \n  \n  \u003Cdiv class=\u0022pane-content\u0022\u003E\n    \u003Cdiv class=\u0022highwire-markup\u0022\u003E\u003Cdiv xmlns=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022 id=\u0022content-block-markup\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\u003Cdiv class=\u0022article fulltext-view \u0022\u003E\u003Cspan class=\u0022highwire-journal-article-marker-start\u0022\u003E\u003C\/span\u003E\u003Cdiv class=\u0022section abstract\u0022 id=\u0022abstract-1\u0022\u003E\u003Ch2\u003ESummary\u003C\/h2\u003E\n            \u003Cp id=\u0022p-1\u0022\u003EThis article presents the results 3 clinical trials for the treatment of chronic obstructive pulmonary disease (COPD). Specific studies include the ANHELTO 1 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01694771\u0026amp;atom=%2Fspmdc%2F14%2F45%2F10.atom\u0022\u003ENCT01694771\u003C\/a\u003E] and 2 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01696058\u0026amp;atom=%2Fspmdc%2F14%2F45%2F10.atom\u0022\u003ENCT01696058\u003C\/a\u003E] trial that evaluated tiotropium + olodaterol, the [GOLDEN-2; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01706536\u0026amp;atom=%2Fspmdc%2F14%2F45%2F10.atom\u0022\u003ENCT01706536\u003C\/a\u003E] study evaluating the efficacy and safety of twice-daily treatment of SUN-101, as well as LAS-MD-38 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01045161\u0026amp;atom=%2Fspmdc%2F14%2F45%2F10.atom\u0022\u003ENCT01045161\u003C\/a\u003E] evaluating twice-daily aclidinium bromide.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EChronic Obstructive Pulmonary Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary \u0026amp; Respiratory Medicine\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EChronic Obstructive Pulmonary Disease\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EThe muscarinic antagonist tiotropium when combined with the \u03b2-2 agonist olodaterol provided significant bronchodilation above that achieved with tiotropium alone in patients with chronic obstructive pulmonary disease (COPD). Richard ZuWallack, MD, St. Francis Hospital and Medical Center, Hartford, Connecticut, USA, presented the results of ANHELTO 1 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01694771\u0026amp;atom=%2Fspmdc%2F14%2F45%2F10.atom\u0022\u003ENCT01694771\u003C\/a\u003E] and 2 [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01696058\u0026amp;atom=%2Fspmdc%2F14%2F45%2F10.atom\u0022\u003ENCT01696058\u003C\/a\u003E], studies that evaluated the effectiveness of tiotropium (18 \u03bcg QD administered with HandiHaler) + olodaterol (5 \u03bcg QD administered with Respimat) in clinically stable patients with COPD.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EBoth were double-blind, randomized, 12-week studies carried out in 184 centers. Patients with post-bronchodilator forced expiratory volume at 1 second (FEV\u003Csub\u003E1\u003C\/sub\u003E) \u2265 30% and \u0026lt; 80% of predicted normal, with post-bronchodilator FEV\u003Csub\u003E1\u003C\/sub\u003E\/forced vital capacity (FVC) \u0026lt; 70%, \u2265 40 years of age, and who are current or ex-smokers with a smoking history of \u0026gt; 10 pack-years were included in the studies. Primary end points were the changes from baseline to 12 weeks in FEV\u003Csub\u003E1\u003C\/sub\u003E area under the curve from 0 to 3 hours (AUC\u003Csub\u003E0\u20133\u003C\/sub\u003E) and trough FEV\u003Csub\u003E1\u003C\/sub\u003E response. Secondary end points included St. George\u0027s Respiratory Questionnaire (SGRQ) score, peak FEV\u003Csub\u003E1\u003C\/sub\u003E, FVC AUC\u003Csub\u003E0\u20133\u003C\/sub\u003E, peak and trough FVC responses, and rescue medication use.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EThe mean ages of the 1132 patients enrolled in the studies were 64.6 (study 1) and 64.1 years (study 2); 49.8% and 53.6%, respectively, were men. The mean duration of COPD diagnosis ranged from 7.1 to 8.5 years.\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003ECompared with tiotropium plus placebo, the combined treatment produced significant improvement in FEV\u003Csub\u003E1\u003C\/sub\u003E AUC\u003Csub\u003E0\u20133\u003C\/sub\u003E response at treatment days 1, 29, and 85 in both studies (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001).\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003ETrough FEV\u003Csub\u003E1\u003C\/sub\u003E response to treatment was also significantly improved by combination therapy compared with tiotropium alone in both studies (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .01). Significant improvements with combined treatment were noted in all secondary end points. Combining olodaterol and tiotropium provided significant improvements in lung function compared with tiotropium + placebo after 12 weeks.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ESUN-101 is a long-acting muscarinic antagonist formulation of glycopyrrolate delivered by the eFlow vibrating mesh nebulizer, and it was shown to be as safe and effective as once-daily dosing in patients with moderate-to-severe COPD [GOLDEN-1; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01426009\u0026amp;atom=%2Fspmdc%2F14%2F45%2F10.atom\u0022\u003ENCT01426009\u003C\/a\u003E]. Edward Kerwin, MD, Sunovion Pharmaceuticals Inc., Marlborough, Massachusetts, USA, presented the results of a recent study [GOLDEN-2; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01706536\u0026amp;atom=%2Fspmdc%2F14%2F45%2F10.atom\u0022\u003ENCT01706536\u003C\/a\u003E] that evaluated the efficacy and safety of twice-daily treatment.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EGOLDEN-2 was a 28-day, randomized, double-blind, placebo-controlled, parallel-arm study that included 282 patients with COPD aged 35 to 75 years, with baseline FEV\u003Csub\u003E1\u003C\/sub\u003E \u2265 30% and \u2264 70% of predicted, and \u2265 10 pack-year smoking history. Patients were randomized to SUN-101 (12.5 mcg, n = 55; 25 mcg, n = 54; 50 mcg, n = 57; or 100 mcg, n = 59) or placebo (n = 57) twice daily. Inhaled corticosteroids and roflumilast were permitted throughout the study. The primary end point was change from baseline in morning trough FEV\u003Csub\u003E1\u003C\/sub\u003E on day 28. The main secondary end point was change from baseline in AUC\u003Csub\u003E0\u201312\u003C\/sub\u003E FEV\u003Csub\u003E1\u003C\/sub\u003E on day 28. Safety was assessed by adverse events (AEs).\u003C\/p\u003E\u003Cp id=\u0022p-9\u0022\u003EAll doses of SUN-101 were associated with significant increases in trough FEV\u003Csub\u003E1\u003C\/sub\u003E on day 28 (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .005). After each dosing, there was rapid onset of bronchodilation, which persisted throughout the dosing interval.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003ESignificant improvements were also seen in FEV\u003Csub\u003E1\u003C\/sub\u003E AUC\u003Csub\u003E0\u201312\u003C\/sub\u003E on day 28 for all doses versus placebo (\u003Cem\u003EP\u003C\/em\u003E \u0026lt; .0001). All doses of SUN-101 were well tolerated, with no deaths and a low incidence of serious AEs. The most commonly reported AEs were exacerbations (3.2%), headache (2.8%), diarrhea (1.8%), and back pain (1.4%). Anticholinergic AEs were infrequent. A comparison of trough FEV\u003Csub\u003E1\u003C\/sub\u003E improvements with once- and twice-daily dosing showed twice-daily dosing to be more effective.\u003C\/p\u003E\u003Cp id=\u0022p-11\u0022\u003ETwice-daily treatment with SUN-101 produced dose-dependent increases in trough FEV\u003Csub\u003E1\u003C\/sub\u003E and FEV\u003Csub\u003E1\u003C\/sub\u003E AUC\u003Csub\u003E0\u201312\u003C\/sub\u003E that were better than once-daily treatment, suggesting this approach is an additional treatment option for patients with moderate-to-severe COPD.\u003C\/p\u003E\u003Cp id=\u0022p-12\u0022\u003ETwo randomized clinical trials using aclidinium bromide to treat moderate-to-severe COPD reported significant improvement in bronchodilation, dyspnea, and health-related quality of life and symptoms [Jones PW et al. \u003Cem\u003EEur Respir J.\u003C\/em\u003E 2012; Rennard SI et al. \u003Cem\u003EClin Drug Investig\u003C\/em\u003E. 2013]. Stephen Rennard, University of Nebraska Medical Center, Omaha, Nebraska, USA, presented results from LAS-MD-38, a long-term safety, tolerability, and efficacy study [\u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01045161\u0026amp;atom=%2Fspmdc%2F14%2F45%2F10.atom\u0022\u003ENCT01045161\u003C\/a\u003E] treating patients with moderate-to-severe COPD with twice-daily aclidinium bromide.\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EThis was an open-label, 40-week extension study of ACCORD COPD II, the 12-week double-blind lead-in trial [Rennard SI et al. \u003Cem\u003EClin Drug Investig\u003C\/em\u003E. 2013]. At 12 weeks, patients (n = 448) were transitioned from placebo (Group 1), 200 \u03bcg aclidinium (Group 2), and 400 \u03bcg aclidinium (Group 3) to open-label aclidinium (400 \u03bcg twice daily). The primary end point was change from baseline in morning predose trough FEV\u003Csub\u003E1\u003C\/sub\u003E at week 52. Additional end points were trough FEV\u003Csub\u003E1\u003C\/sub\u003E at all time points, dyspnea status (Transition Dyspnea Index [TDI] focal score), and health-related quality of life (SGRQ total score). No statistical comparisons were made. Safety, the primary outcome, was assessed via AEs of new or increased intensity during this extension study. Patients were mean age 62.7 years; 54.6% were men. Mean smoking pack-years was 54.2; mean pre- and post-bronchodilator FEV\u003Csub\u003E1\u003C\/sub\u003E were 1.37 and 52.7 mL, respectively; and 53.6% of patients had COPD of moderate severity.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EAclidinium (400 mg) is well tolerated and an effective, long-term therapeutic option in moderate-to-severe COPD.\u003C\/p\u003E\u003Cdiv id=\u0022F1\u0022 class=\u0022fig pos-float  odd\u0022\u003E\u003Cdiv class=\u0022highwire-figure\u0022\u003E\u003Cdiv class=\u0022fig-inline-img-wrapper\u0022\u003E\u003Cdiv class=\u0022fig-inline-img\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/45\/10\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022The editors would like to thank the many members of the 2014 American College of Chest Physicians presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-794856968\u0022 data-figure-caption=\u0022The editors would like to thank the many members of the 2014 American College of Chest Physicians presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure1\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/45\/10\/F1.medium.gif\u0022\/\u003E\u003C\/a\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022highwire-figure-links inline\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/45\/10\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure1\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload figure\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/45\/10\/F1.large.jpg\u0022 class=\u0022highwire-figure-link highwire-figure-link-newtab\u0022 target=\u0022_blank\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EOpen in new tab\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/15506\u0022 class=\u0022highwire-figure-link highwire-figure-link-ppt\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EDownload powerpoint\u003C\/a\u003E\u003C\/li\u003E\u003C\/ul\u003E\u003C\/div\u003E\u003Cdiv class=\u0022fig-caption\u0022 xmlns:xhtml=\u0022http:\/\/www.w3.org\/1999\/xhtml\u0022\u003E\n            \u003Cp id=\u0022p-15\u0022 class=\u0022first-child\u0022\u003EThe editors would like to thank the many members of the 2014 American College of Chest Physicians presenting faculty who generously gave their time to ensure the accuracy and quality of the articles in this publication.\u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2014 MD Conference Express\u00ae\u003C\/li\u003E\u003C\/ul\u003E\u003Cspan class=\u0022highwire-journal-article-marker-end\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Cspan id=\u0022related-urls\u0022\u003E\u003C\/span\u003E\u003C\/div\u003E\u003Ca href=\u0022http:\/\/mdc.sagepub.com\/content\/14\/45\/10.abstract\u0022 class=\u0022hw-link hw-link-article-abstract\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView Summary\u003C\/a\u003E\u003C\/div\u003E  \u003C\/div\u003E\n\n  \n  \u003C\/div\u003E\n\u003C\/div\u003E\n  \u003C\/div\u003E\n\u003C\/div\u003E\n\u003C\/div\u003E\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_figures.js?nzohv1\u0022\u003E\u003C\/script\u003E\n\u003Cscript type=\u0022text\/javascript\u0022 src=\u0022http:\/\/mdc.sagepub.com\/sites\/all\/modules\/highwire\/highwire\/plugins\/highwire_markup_process\/js\/highwire_openurl.js?nzohv1\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}