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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\u003ETreatment of chronic bronchopulmonary infection by \u003Cem\u003EPseudomonas aeruginosa\u003C\/em\u003E in patients with cystic fibrosis (CF) with liposomal amikacin for inhalation (LAI) resulted in improved pulmonary function and decreased P aeruginosa sputum concentration in an interim analysis. This article discusses interim data from the Long Term Safety and Tolerability of Open-Label Liposomal Amikacin for Inhalation in Cystic Fibrosis Patients With Chronic Infection due to \u003Cem\u003EPseudomonas aeruginosa\u003C\/em\u003E trial [CLEAR-110; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01316276\u0026amp;atom=%2Fspmdc%2F14%2F11%2F22.2.atom\u0022\u003ENCT01316276\u003C\/a\u003E; Bilton D et al. \u003Cem\u003EAm J Respir Crit Care Med\u003C\/em\u003E 2014].\u003C\/p\u003E\n         \u003C\/div\u003E\u003Cul class=\u0022kwd-group\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ELower Respiratory Infections\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary Clinical Trials\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003ELower Respiratory Infections\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary \u0026amp; Critical Care\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003ETreatment of chronic bronchopulmonary infection by \u003Cem\u003EPseudomonas aeruginosa\u003C\/em\u003E in patients with cystic fibrosis (CF) with liposomal amikacin for inhalation (LAI) resulted in improved pulmonary function and decreased \u003Cem\u003EP aeruginosa\u003C\/em\u003E sputum concentration in an interim analysis. Diana Bilton, MD, Royal Brompton Hospital, London, United Kingdom, presented interim data from the Long Term Safety and Tolerability of Open-Label Liposomal Amikacin for Inhalation in Cystic Fibrosis Patients With Chronic Infection due to \u003Cem\u003EPseudomonas aeruginosa\u003C\/em\u003E trial [CLEAR-110; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01316276\u0026amp;atom=%2Fspmdc%2F14%2F11%2F22.2.atom\u0022\u003ENCT01316276\u003C\/a\u003E; Bilton D et al. \u003Cem\u003EAm J Respir Crit Care Med\u003C\/em\u003E 2014].\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003EThe study treatment consists of amikacin formulated within biocompatible liposomes of about 0.3 \u00b5m, which are able to penetrate the biofilm formed by \u003Cem\u003EP aeruginosa\u003C\/em\u003E and nontuberculous mycobacteria. The CLEAR-108 study showed that LAI treatment resulted in similar forced expiratory volume in 1 second (FEV\u003Csub\u003E1\u003C\/sub\u003E) in patients with cystic fibrosis and chronic \u003Cem\u003EP aeruginosa\u003C\/em\u003E infection as compared with tobramycin inhalation solution (TIS). Patients who completed CLEAR-108 were eligible to enroll in the extension study, CLEAR-110. The purpose of the CLEAR-110 study was to determine the long-term safety and efficacy of LAI.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn CLEAR-110\u2014a multicenter, open-label, Phase 3 study\u2014206 patients aged \u22656 years received 6 cycles of LAI (28 days on, 28 days off) in the first extension and an additional 6 cycles in the second extension. Patients were assessed monthly by the Cystic Fibrosis Questionnaire\u2013 Revised, colony-forming units, need for antibiotic rescue treatment, pulmonary exacerbation, and hospitalizations. The patients had a mean age of 21 years and a\u003C\/p\u003E\u003Cp id=\u0022p-5\u0022\u003Emean FEV\u003Csub\u003E1\u003C\/sub\u003E percent predicted of 65.5. The primary outcome measures were the relative change in FEV\u003Csub\u003E1\u003C\/sub\u003E and FEV\u003Csub\u003E1\u003C\/sub\u003E percent predicted, the incidence of treatment-emergent adverse events, and acute tolerability. Secondary efficacy outcomes included a relative change in FEV\u003Csub\u003E1\u003C\/sub\u003E and FEV\u003Csub\u003E1\u003C\/sub\u003E percent predicted, time to first protocol-defined pulmonary exacerbation, time to first antipseudomonal antibiotic treatment, shift in minimum inhibitory concentration, and evaluation of emergent pathogens.\u003C\/p\u003E\u003Cp id=\u0022p-6\u0022\u003ECommon (\u0026gt;10%) treatment-related adverse events included infective pulmonary exacerbations of cystic fibrosis, nasopharyngitis, upper respiratory tract infection, hemoptysis, cough, and dysphonia. Most adverse events were mild to moderate in severity, and none of the patients receiving LAI discontinued the study drug due to treatment-related adverse events.\u003C\/p\u003E\u003Cp id=\u0022p-7\u0022\u003ETreatment with LAI resulted in a sustained improvement in FEV\u003Csub\u003E1\u003C\/sub\u003E from baseline over the study period (\u003Ca id=\u0022xref-fig-1-1\u0022 class=\u0022xref-fig\u0022 href=\u0022#F1\u0022\u003EFigure 1\u003C\/a\u003E). In addition, patients enrolled in CLEAR-110 who had received TIS in the CLEAR-108 trial showed an increase in FEV\u003Csub\u003E1\u003C\/sub\u003E. Similarly, patients who had received LAI in the CLEAR-108 trial experienced sustained improvement in FEV\u003Csub\u003E1\u003C\/sub\u003E during LAI treatment in the CLEAR-110 trial.\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\/11\/22.2\/F1.large.jpg?width=800\u0026amp;height=600\u0026amp;carousel=1\u0022 title=\u0022Effect of Long-Term LAI Treatment on FEV1             \u0022 class=\u0022fragment-images colorbox-load\u0022 rel=\u0022gallery-fragment-images-404458268\u0022 data-figure-caption=\u0022\u0026amp;lt;div xmlns=\u0026amp;quot;http:\/\/www.w3.org\/1999\/xhtml\u0026amp;quot;\u0026amp;gt;Effect of Long-Term LAI Treatment on FEV\u0026amp;lt;sub\u0026amp;gt;1\u0026amp;lt;\/sub\u0026amp;gt;             \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 1.\u0022 src=\u0022http:\/\/d282kpwvnogo5m.cloudfront.net\/content\/spmdc\/14\/11\/22.2\/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\/11\/22.2\/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\/14\/11\/22.2\/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\/14357\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-8\u0022 class=\u0022first-child\u0022\u003EEffect of Long-Term LAI Treatment on FEV\u003Csub\u003E1\u003C\/sub\u003E\n            \u003C\/p\u003E\n         \u003Cq class=\u0022attrib\u0022 id=\u0022attrib-1\u0022\u003ENote: Shaded regions represent 28 days on-treatment; dashed line represents baseline.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-2\u0022\u003EFEV\u003Csub\u003E1\u003C\/sub\u003E=forced expiratory volume in 1 second; LAI=liposomal amikacin for inhalation.\u003C\/q\u003E\u003Cq class=\u0022attrib\u0022 id=\u0022attrib-3\u0022\u003EReproduced with permission from D Bilton, MD.\u003C\/q\u003E\u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-9\u0022\u003EThe density of \u003Cem\u003EP aeruginosa\u003C\/em\u003E in sputum appeared to generally decrease from baseline levels, regardless of treatment assignment in CLEAR-108.\u003C\/p\u003E\u003Cp id=\u0022p-10\u0022\u003EIn conclusion, Dr. Bilton stated that, in her opinion, the data from the CLEAR-110 extension trial suggest that LAI was well tolerated in patients with cystic fibrosis and chronic infection by \u003Cem\u003EP aeruginosa\u003C\/em\u003E. In addition, LAI treatment may improve long-term pulmonary function. Dr. Bilton also pointed out that this interim analysis did not include the entire study population, as the trial is ongoing; therefore, conclusions of the data cannot yet be determined.\u003C\/p\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\/11\/22.2.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?nzp28d\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?nzp28d\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}