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type=\u0022text\/css\u0022 rel=\u0022stylesheet\u0022 href=\u0022\/\/d282kpwvnogo5m.cloudfront.net\/sites\/default\/files\/cdn\/css\/http\/css_Xg7z6oCTVgud_Q0huYz9x9iiD5H_2YPSJ5z2ZViSWdY.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\u003EA once-daily inhaled dual bronchodilator consisting of a long-acting \u03b22-agonist and a long-acting muscarinic antagonist significantly improved self-reported shortness of breath and lung function compared with placebo and tiotropium in patients with moderate to severe chronic obstructive pulmonary disease. This article discusses results of the Effect of QVA149 on Dyspnea in Patients With Chronic Obstructive Pulmonary Disease study [BLAZE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01490125\u0026amp;atom=%2Fspmdc%2F13%2F4%2F19.atom\u0022\u003ENCT01490125\u003C\/a\u003E], a multicenter, randomized, blinded, double-dummy, placebo-controlled, 3-period, crossover trial.\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EChronic Obstructive Pulmonary Disease Pulmonary Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EChronic Obstructive Pulmonary Disease\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary \u0026amp; Critical Care\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EA once-daily inhaled dual bronchodilator consisting of a long-acting \u03b22-agonist and a long-acting muscarinic antagonist (QVA149) significantly improved self-reported shortness of breath and lung function compared with placebo and tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD).\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EDonald A. Mahler, MD, Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire, USA, presented results of the Effect of QVA149 on Dyspnea in Patients With Chronic Obstructive Pulmonary Disease study [BLAZE; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01490125\u0026amp;atom=%2Fspmdc%2F13%2F4%2F19.atom\u0022\u003ENCT01490125\u003C\/a\u003E], a multicenter, randomized, blinded, double-dummy, placebo-controlled, 3-period, crossover trial.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EDyspnea in COPD is not always controlled adequately by bronchodilator monotherapy, providing the rationale for combining two bronchodilators with different mechanisms of action [Rabe KF et al. \u003Cem\u003EAm J Respir Crit Care Med\u003C\/em\u003E 2007; Vestbo J et al. \u003Cem\u003EAm J Respir Crit Care Med\u003C\/em\u003E 2013]. QVA149 is an investigational fixed-dose combination of indacaterol maleate 110 \u03bcg and glycopyrronium bromide 50 \u03bcg. QVA149 had previously demonstrated improvements in dyspnea versus its individual components, tiotropium, and salmeterol\/fluticasone using the interviewer-based Transition Dyspnea Index (TDI) [Bateman ED et al. \u003Cem\u003EEur Respir J\u003C\/em\u003E 2013; Vogelmeier C et al. \u003Cem\u003ERespir Med\u003C\/em\u003E 2013].\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003EIn BLAZE, patients with moderate to severe COPD (n=246) were randomized to once-daily QVA149, tiotropium 18 \u03bcg, or placebo. Patients were current or former smokers, had a Modified Medical Research Council scale of \u0026gt;2 at screening, a postbronchodilator forced expiratory volume in 1 second (FEV\u003Csub\u003E1\u003C\/sub\u003E) \u226530 and \u0026lt;80% predicted, and FEV\u003Csub\u003E1\u003C\/sub\u003E\/forced vital capacity \u0026lt;0.7. There was a 2-week washout between crossover periods.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003EThe primary objective was superiority of QVA149 versus placebo on the improvement in patient-reported levels of breathlessness during daily activities using the Self-Administered Computerized (SAC) version of the Baseline Dyspnea Index (BDI)\/TDI after 6 weeks. The SAC version of the BDI\/TDI was developed as a tool to provide direct patient-reported ratings of dyspnea and to provide a standard method to reduce the potential bias with an interviewer [Mahler DA et al. \u003Cem\u003ECOPD\u003C\/em\u003E 2004]. The secondary objective was superiority of QVA149 versus tiotropium on the same endpoint.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003EOther secondary objectives included evaluation for lung function by FEV\u003Csub\u003E1\u003C\/sub\u003E area under the curve from 0 to 4 hours (AUC\u003Csub\u003E0\u20134h\u003C\/sub\u003E) and rescue medication use over 6 weeks.\u003C\/p\u003E\u003Cp id=\u0022p-8\u0022\u003EAfter 6 weeks of treatment, QVA149 significantly improved patient self-reported shortness of breath during daily activities versus placebo (\u0394=1.37; p\u0026lt;0.001) and versus tiotropium (\u0394=0.49; p=0.021). Significantly more moderate COPD patients achieved \u22651 point TDI total score improvement on QVA149 (35.9%) versus placebo (18.1%; p\u0026lt;0.001) and tiotropium (24.4%; p=0.012). Subgroup analysis showed that the improvement in the SAC TDI with QVA149 was more pronounced in patients with severe COPD (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E).\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\/13\/4\/19\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Subgroup Analysis by COPD Severity\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1859129142\u0022 data-figure-caption=\u0022Subgroup Analysis by COPD Severity\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/13\/4\/19\/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\/13\/4\/19\/F1.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 1.\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\/13\/4\/19\/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\/13104\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 attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-9\u0022 class=\u0022first-child\u0022\u003ESubgroup Analysis by COPD Severity\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003ECOPD=chronic obstructive pulmonary disease; LS=least squares; NS=nonsignificant; SE=standard error; TDI=Transition Dyspnea Index.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EReproduced with permission from DA Mahler, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-10\u0022\u003EQVA149 produced significant and clinically meaningful improvements in FEV\u003Csub\u003E1\u003C\/sub\u003E AUC\u003Csub\u003E0\u20134h\u003C\/sub\u003E versus placebo and versus tiotropium on Day 1 and Week 6 (p\u0026lt;0.001 for both comparisons; \u003Ca id=\u0022xref-fig-2-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F2\u0022\u003EFigure 2\u003C\/a\u003E).\u003C\/p\u003E\u003Cdiv id=\u0022F2\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\/13\/4\/19\/F2.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022FEV1 Area Under the Curve\u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-1859129142\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;FEV\u0026amp;lt;sub\u0026amp;gt;1\u0026amp;lt;\/sub\u0026amp;gt; Area Under the Curve\u0026amp;lt;\/div\u0026amp;gt;\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003E\u003Cimg class=\u0022fragment-image\u0022 alt=\u0022Figure 2.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/13\/4\/19\/F2.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\/13\/4\/19\/F2.large.jpg?download=true\u0022 class=\u0022highwire-figure-link highwire-figure-link-download\u0022 title=\u0022Download Figure 2.\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\/13\/4\/19\/F2.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\/13105\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 attrib\u0022\u003E\u003Cspan class=\u0022fig-label\u0022\u003EFigure 2.\u003C\/span\u003E \n            \u003Cp id=\u0022p-11\u0022 class=\u0022first-child\u0022\u003EFEV\u003Csub\u003E1\u003C\/sub\u003E Area Under the Curve\u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-3\u0022\u003EAUC\u003Csub\u003E0\u20134h\u003C\/sub\u003E=area under the curve from 0 to 4 hours; FEV\u003Csub\u003E1\u003C\/sub\u003E=forced expiratory volume in 1 second; LS=least squares; SE=standard error.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-4\u0022\u003EReproduced with permission from DA Mahler, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-12\u0022\u003ERescue medication use over 6 weeks was significantly lower with QVA149 versus placebo (\u22121.43 puffs\/day; p\u0026lt;0.001) and tiotropium (\u22120.45 puffs\/day; p=0.002).\u003C\/p\u003E\u003Cp id=\u0022p-13\u0022\u003EQVA149 was well tolerated. The most frequent adverse events (COPD, nasopharyngitis, cough, and dyspnea) occurred with similar frequency to that of placebo and tiotropium.\u003C\/p\u003E\u003Cp id=\u0022p-14\u0022\u003EResults from BLAZE add to the evidence that improved lung function with once-daily QVA149 translates into greater relief of breathlessness and improved patient-reported outcomes, concluded Dr. Mahler.\u003C\/p\u003E\u003Cul class=\u0022copyright-statement\u0022\u003E\u003Cli class=\u0022fn\u0022 id=\u0022copyright-statement-1\u0022\u003E\u00a9 2013 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\/13\/4\/19.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?nznxhp\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?nznxhp\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}