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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\u003EIn patients with severe asthma who depend on long-term oral corticosteroid therapy, additional treatment with consistent doses of budesonide (BUD) delivered by a novel inhalation system significantly improved lung function and control of asthma exacerbations. This article discusses outcomes from the AKITA Inhaled Steroid Suspension for Inhalation in Subjects With Asthma [AICS; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01200108\u0026amp;atom=%2Fspmdc%2F14%2F11%2F17.atom\u0022\u003ENCT01200108\u003C\/a\u003E; Canisius S et al. \u003Cem\u003EAm J Respir Crit Care\u003C\/em\u003E 2014]\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\u003EAsthma\u003C\/li\u003E\u003C\/ul\u003E\u003Cul class=\u0022kwd-group clinical-trial\u0022\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary Clinical Trials\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EPulmonary \u0026amp; Critical Care\u003C\/li\u003E\u003Cli class=\u0022kwd\u0022\u003EAsthma\u003C\/li\u003E\u003C\/ul\u003E\u003Cp id=\u0022p-2\u0022\u003EIn patients with severe asthma who depend on long-term oral corticosteroid therapy, additional treatment with consistent doses of budesonide (BUD) delivered by a novel inhalation system significantly improved lung function and control of asthma exacerbations.\u003C\/p\u003E\u003Cp id=\u0022p-3\u0022\u003ESebastian Canisius, MD, Vectura GmbH, Frankfurt, Germany, reported outcomes from the AKITA Inhaled Steroid Suspension for Inhalation in Subjects With Asthma [AICS; \u003Ca class=\u0022external-ref external-ref-type-clintrialgov\u0022 href=\u0022\/lookup\/external-ref?link_type=CLINTRIALGOV\u0026amp;access_num=NCT01200108\u0026amp;atom=%2Fspmdc%2F14%2F11%2F17.atom\u0022\u003ENCT01200108\u003C\/a\u003E; Canisius S et al. \u003Cem\u003EAm J Respir Crit Care\u003C\/em\u003E 2014]\u2014a Phase 2\/3, randomized, placebo-controlled trial featuring 4 arms and parallel groups. In it, researchers evaluated the efficacy of a novel computer-controlled, compressor-driven inhalation system (Akita; Activaero) that delivered consistent doses of BUD as add-on treatment in patients with severe asthma on long-term oral corticosteroids therapy.\u003C\/p\u003E\u003Cp id=\u0022p-4\u0022\u003EIn the study, adult patients (age, 18 to 65 years; \u003Ca id=\u0022xref-table-wrap-1-1\u0022 class=\u0022xref-table\u0022 href=\u0022#T1\u0022\u003ETable 1\u003C\/a\u003E) from 27 respiratory outpatient centers in Germany, Poland, and Ukraine were randomly assigned in a double-blind fashion to 1 of 4 treatment arms for 18 weeks:\u003C\/p\u003E\u003Col class=\u0022list-ord \u0022 id=\u0022list-1\u0022\u003E\u003Cli id=\u0022list-item-1\u0022\u003E\n            \u003Cp id=\u0022p-5\u0022\u003EAICS-BUD (1 mg): AKITA-inhaled corticosteroid+BUD (1 mg, twice a day [BID]; n=80)\u003C\/p\u003E\n         \u003C\/li\u003E\u003Cli id=\u0022list-item-2\u0022\u003E\n            \u003Cp id=\u0022p-6\u0022\u003EAICS-BUD (0.5 mg): AKITA-inhaled corticosteroid+ BUD (0.5 mg, BID; n=39)\u003C\/p\u003E\n         \u003C\/li\u003E\u003Cli id=\u0022list-item-3\u0022\u003E\n            \u003Cp id=\u0022p-7\u0022\u003EAICS-placebo: AKITA-inhaled corticosteroid+placebo (BID; n=40)\u003C\/p\u003E\n         \u003C\/li\u003E\u003Cli id=\u0022list-item-4\u0022\u003E\n            \u003Cp id=\u0022p-8\u0022\u003ECN-BUD: open-label treatment with BUD (1 mg, BID) administered with a conventional nebulizer (n=40)\u003C\/p\u003E\n         \u003C\/li\u003E\u003C\/ol\u003E\u003Cp id=\u0022p-9\u0022\u003EThe doses of long-term corticosteroid therapy were tapered until Week 14, and patients were followed to Week 20.\u003C\/p\u003E\u003Cdiv id=\u0022T1\u0022 class=\u0022table pos-float\u0022\u003E\u003Cdiv class=\u0022table-inline\u0022\u003E\u003Cdiv class=\u0022callout\u0022\u003E\u003Cspan\u003EView this table:\u003C\/span\u003E\u003Cul class=\u0022callout-links\u0022\u003E\u003Cli class=\u00220 first\u0022\u003E\u003Ca href=\u0022\/\u0022 class=\u0022table-expand-inline\u0022 data-table-url=\u0022\/highwire\/markup\/14345\/expansion?postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media%2Chighwire_embed\u0026amp;table-expand-inline=1\u0022 html=\u00221\u0022 fragment=\u0022#\u0022 external=\u00221\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView inline\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00221\u0022\u003E\u003Ca href=\u0022\/highwire\/markup\/14345\/expansion?width=1000\u0026amp;height=500\u0026amp;iframe=true\u0026amp;postprocessors=highwire_figures%2Chighwire_math%2Chighwire_inline_linked_media\u0022 class=\u0022colorbox colorbox-load table-expand-popup\u0022 rel=\u0022gallery-fragment-tables\u0022 data-icon-position=\u0022\u0022 data-hide-link-title=\u00220\u0022\u003EView popup\u003C\/a\u003E\u003C\/li\u003E\u003Cli class=\u00222 last\u0022\u003E\u003Ca href=\u0022\/highwire\/powerpoint\/14345\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\u003C\/div\u003E\u003Cdiv class=\u0022table-caption\u0022\u003E\u003Cspan class=\u0022table-label\u0022\u003ETable 1.\u003C\/span\u003E \n            \u003Cp id=\u0022p-10\u0022 class=\u0022first-child\u0022\u003EBaseline Characteristics\u003Csup\u003E\u003Csup\u003Ea\u003C\/sup\u003E\u003C\/sup\u003E\n            \u003C\/p\u003E\n         \u003Cdiv class=\u0022sb-div caption-clear\u0022\u003E\u003C\/div\u003E\u003C\/div\u003E\u003C\/div\u003E\u003Cp id=\u0022p-16\u0022\u003EEfficacy was assessed on the basis of lung function parameters, including mean forced expiratory volume in 1 second (FEV\u003Csub\u003E1\u003C\/sub\u003E), as well as mean change in forced expiratory flow from 25% to 75% of vital capacity, which (FEF\u003Csub\u003E25\u201375\u003C\/sub\u003E) that the authors noted is a fairly reliable surrogate marker of small airway function. These lung function parameters were recorded during each patient visit for 2 weeks.\u003C\/p\u003E\u003Cp id=\u0022p-17\u0022\u003EOverall, the study revealed that the dose of long-term oral corticosteroids was reduced in all treatment arms. For patients who received add-on therapy, lung function parameters improved significantly at Week 18 from baseline, whereas no significant improvements were seen in patients in the placebo and conventional nebulizer arms. The mean FEV\u003Csub\u003E1\u003C\/sub\u003E were 239 mL (p\u0026lt;0.001) and 126 mL (p=0.01) for AICS-BUD (1 mg) and AICS-BUD (0.5 mg), respectively, and 93 mL (p=0.36) and 137 mL (p=0.18) for placebo and CN-BUD, respectively. Regarding small airway function, the study revealed that patients treated with AICS-BUD (1 mg) had significant improvement in mean FEF\u003Csub\u003E25\u201375\u003C\/sub\u003E from baseline to Week 18 compared with patients in the AICS-placebo arm. The study also indicated that patients treated with AICS-BUD (1 mg), compared with those treated by CN-BUD, had fewer asthma exacerbations (7.5% vs 22.5%), a longer mean time to first exacerbation (96.5 vs 50.1 days), and a smaller subsample of patients who experienced asthma instability (15.0% vs 25.0%).\u003C\/p\u003E\u003Cp id=\u0022p-18\u0022\u003EThese findings show an improvement in lung function 12 weeks after initiation of consistent dosing of BUD via a novel delivery system. Without controlling for differences among treatment groups, there appears to be greater benefit of consistent delivery of BUD (1 mg) over similar dosing with a conventional nebulizer.\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\/17.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_openurl.js?nzp203\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_tables.js?nzp203\u0022\u003E\u003C\/script\u003E\n\u003C\/body\u003E\u003C\/html\u003E"}