{"id":91440,"date":"2024-07-18T08:43:07","date_gmt":"2024-07-18T13:43:07","guid":{"rendered":"https:\/\/pulmonx.com\/the-liberate-study\/"},"modified":"2024-08-12T09:58:42","modified_gmt":"2024-08-12T14:58:42","slug":"the-liberate-study","status":"publish","type":"post","link":"https:\/\/pulmonx.com\/uk-en\/the-liberate-study\/","title":{"rendered":"The LIBERATE Study"},"content":{"rendered":"\n
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\n \"Zephyr-Valve-Liberate-Clinical-Study\" \n <\/div>\n \n \n <\/div>\n\n
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The benefits are comparable to those seen with LVRS (lung volume reduction surgery) but with a reduction in post-procedure morbidity.\u201d1<\/sup><\/a><\/p>\n

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\n \n Download Study Summary <\/a>\n <\/div>\n <\/div>\n\n <\/div>\n
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Published in The American Journal of Respiratory and Critical Care Medicine1<\/sup><\/a><\/h1>\n

A multicentre, multinational randomised controlled trial of Zephyr\u00ae <\/sup>Endobronchial Valves in patients with heterogenous emphysema and little to no collateral ventilation.<\/p>\n

Methods & Endpoints<\/h3>\n
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  • First multicentre to evaluate effectiveness and safety of Zephyr Endobronchial Valves in patients with little to no collateral ventilation (CV) out to 12 months<\/li>\n
  • 190 subjects with hyperinflation (mean baseline RV, 225% pred.; FEV1<\/sub>, 27% pred.; DLCO, 34% pred.) randomized 2:1 (128 Zephyr Valve: 62 SoC)<\/li>\n<\/ul> <\/div>\n<\/div>\n <\/div>\n <\/div>\n <\/div>\n
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    Study Design<\/h2> <\/div>\n<\/div>\n\n
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    \n \"LIBERATE-Study-Design\" \n <\/div>\n \n \n <\/div>\n\n
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    Results in ITT Population<\/h2> <\/div>\n<\/div>\n
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    Primary Endpoint Responder Analysis<\/h4>\n

    Percent of Subjects with FEV1<\/sub> Change of \u226515%<\/h5> <\/div>\n<\/div>\n\n
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<!-- module text -->\n<div class=\"module module-text tb_vi93559 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center\">Change in St. George\u2019s Resp Questionnaire<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_5lz7540 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>LIBERATE - SGRQ - Line | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/cdn.amcharts.com\/lib\/3\/serial.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/themes\/light.js\"><\/script>\r\n\t\t\r\n\r\n\t\t<!-- amCharts javascript code 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module-text tb_uj4n492 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center\">Change in FEV<sub>1<\/sub><\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_qjpk207 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>LIBERATE - FEV1 - Line | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/cdn.amcharts.com\/lib\/3\/serial.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/themes\/light.js\"><\/script>\r\n\t\t\r\n\r\n\t\t<!-- amCharts javascript code -->\r\n\t\t<script 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Group Difference\": \".135\"\r\n\t\t\t\t\t\t},\r\n\t\t\t\t\t\t{\r\n\t\t\t\t\t\t\t\"category\": \"12 Months\",\r\n\t\t\t\t\t\t\t\"EBV\": \".11\",\r\n\t\t\t\t\t\t\t\"Control\": \"-.002\",\r\n\t\t\t\t\t\t\t\"EBV Candle High\": \".13\",\r\n\t\t\t\t\t\t\t\"EBVCandle Low\": \".09\",\r\n\t\t\t\t\t\t\t\"EBV open\": \".13\",\r\n\t\t\t\t\t\t\t\"EBV close\": \".09\",\r\n\t\t\t\t\t\t\t\"Control High\": \".02\",\r\n\t\t\t\t\t\t\t\"Control low\": \"-.02\",\r\n\t\t\t\t\t\t\t\"Control open\": \".02\",\r\n\t\t\t\t\t\t\t\"Control close\": \"-.02\",\r\n\t\t\t\t\t\t\t\"Between Group Difference\": \".11\"\r\n\t\t\t\t\t\t}\r\n\t\t\t\t\t]\r\n\t\t\t\t}\r\n\t\t\t);\r\n\t\t<\/script>\r\n\t<\/head>\r\n\t<body>\r\n\t\t<div id=\"liberate-fev1-l\" style=\"width: 100%; height: 400px; background-color: #FFFFFF;\" ><\/div>\r\n\t<\/body>\r\n<\/html> <\/div>\n<\/div>\n<!-- \/module plain text --> <\/div>\n <div data-lazy=\"1\" class=\"module_column sub_column col3-1 tb_pdv8225 last\">\n <!-- module text -->\n<div class=\"module module-text tb_as6s700 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h5 style=\"text-align: center\">Change in 6MWD<\/h5> <\/div>\n<\/div>\n<!-- \/module text --><!-- module plain text -->\n<div class=\"module module-plain-text tb_czlg578 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <!DOCTYPE html>\r\n<html>\r\n\t<head>\r\n\t\t<title>LIBERATE - 6MWD - Line | amCharts<\/title>\r\n\t\t<meta name=\"description\" content=\"chart created using amCharts live editor\" \/>\r\n\t\t\r\n\t\t<!-- amCharts javascript sources -->\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/amcharts.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/cdn.amcharts.com\/lib\/3\/serial.js\"><\/script>\r\n\t\t<script type=\"text\/javascript\" src=\"https:\/\/www.amcharts.com\/lib\/3\/themes\/light.js\"><\/script>\r\n\t\t\r\n\r\n\t\t<!-- amCharts javascript code -->\r\n\t\t<script type=\"text\/javascript\">\r\n\t\t\tAmCharts.makeChart(\"liberate-6mwd-m\",\r\n\t\t\t\t{\r\n \"hideCredits\": \"true\",\r\n\t\t\t\t\t\"type\": \"serial\",\r\n\t\t\t\t\t\"categoryField\": \"category\",\r\n\t\t\t\t\t\"autoMarginOffset\": 0,\r\n\t\t\t\t\t\"autoMargins\": false,\r\n\t\t\t\t\t\"marginBottom\": 32,\r\n\t\t\t\t\t\"marginLeft\": 60,\r\n\t\t\t\t\t\"marginTop\": 65,\r\n\t\t\t\t\t\"sequencedAnimation\": false,\r\n\t\t\t\t\t\"startDuration\": 2,\r\n\t\t\t\t\t\"startEffect\": \"easeOutSine\",\r\n\t\t\t\t\t\"accessibleTitle\": \"changein6mwdmeters\",\r\n\t\t\t\t\t\"backgroundAlpha\": 0.8,\r\n\t\t\t\t\t\"fontFamily\": \"Arial\",\r\n\t\t\t\t\t\"fontSize\": 14,\r\n\t\t\t\t\t\"pathToImages\": \"http:\/\/cdn.amcharts.com\/lib\/3\/images\/\",\r\n\t\t\t\t\t\"percentPrecision\": 1,\r\n\t\t\t\t\t\"precision\": 1,\r\n\t\t\t\t\t\"theme\": \"light\",\r\n\t\t\t\t\t\"categoryAxis\": {\r\n\t\t\t\t\t\t\"classNameField\": \"\",\r\n\t\t\t\t\t\t\"gridPosition\": 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data-lazy=\"1\" class=\"module_column sub_column col-full tb_gf5k87 first\">\n <!-- module text -->\n<div class=\"module module-text tb_2smb156 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h3>Safety: Pulmonary Serious Adverse Events (SAEs) Occurring in at Least 3.0% of Subjects in Either Group<\/h3> <\/div>\n<\/div>\n<!-- \/module text --><!-- module text -->\n<div class=\"module module-text tb_9jun652 hide-tablet hide-mobile\" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n \n<table id=\"tablepress-1\" class=\"tablepress tablepress-id-1 study tbody-has-connected-cells\" aria-describedby=\"tablepress-1-description\">\n<tbody class=\"row-striping\">\n<tr class=\"row-1\">\n\t<td class=\"column-1\"><\/td><td colspan=\"2\" class=\"column-2\">Treatment Period<br \/>\n(0\u201345 Days)<\/td><td colspan=\"2\" class=\"column-4\">Longer Term Period<br \/>\n(46 Days\u20131 Year)<\/td>\n<\/tr>\n<tr class=\"row-2\">\n\t<td class=\"column-1\"><\/td><td class=\"column-2\">Zephyr Valve (n=128)<\/td><td class=\"column-3\">SoC (n=62)<\/td><td class=\"column-4\">Zephyr Valve (n=122)<\/td><td class=\"column-5\">SoC (n=62)<\/td>\n<\/tr>\n<tr class=\"row-3\">\n\t<td class=\"column-1\">Death<\/td><td class=\"column-2\">3.1%<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">0.8%<\/td><td class=\"column-5\">1.6%<\/td>\n<\/tr>\n<tr class=\"row-4\">\n\t<td class=\"column-1\">Pneumothorax<\/td><td class=\"column-2\">26.6%*<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">6.6%<\/td><td class=\"column-5\">0%<\/td>\n<\/tr>\n<tr class=\"row-5\">\n\t<td class=\"column-1\">COPD exacerbation<\/td><td class=\"column-2\">7.8%<\/td><td class=\"column-3\">4.8%<\/td><td class=\"column-4\">23.0%<\/td><td class=\"column-5\">30.6%<\/td>\n<\/tr>\n<tr class=\"row-6\">\n\t<td class=\"column-1\">Pneumonia<\/td><td class=\"column-2\">0.8%<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">5.7%<\/td><td class=\"column-5\">8.1%<\/td>\n<\/tr>\n<tr class=\"row-7\">\n\t<td class=\"column-1\">Respiratory failure<\/td><td class=\"column-2\">1.6%<\/td><td class=\"column-3\">0%<\/td><td class=\"column-4\">0.8%<\/td><td class=\"column-5\">3.2%<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<span id=\"tablepress-1-description\" class=\"tablepress-table-description tablepress-table-description-id-1\">*Statistically different from SoC<\/span>\n<!-- #tablepress-1 from cache --> <\/div>\n<\/div>\n<!-- \/module text --><!-- module image -->\n<div class=\"module module-image tb_13b1442 image-center tf_mw hide-desktop hide-tablet_landscape\" data-lazy=\"1\">\n <div class=\"image-wrap tf_rel tf_mw\">\n <img decoding=\"async\" width=\"1200\" height=\"360\" src=\"https:\/\/pulmonx.com\/wp-content\/uploads\/2019\/12\/Pulmonx-Zephyr-LIBERATE-Clinical-Study-Table.jpg\" class=\"wp-post-image wp-image-520\" title=\"Pulmonx-Zephyr-LIBERATE-Clinical-Study-Table\" alt=\"Pulmonx-Zephyr-LIBERATE-Clinical-Study-Table\" srcset=\"https:\/\/pulmonx.com\/wp-content\/uploads\/2019\/12\/Pulmonx-Zephyr-LIBERATE-Clinical-Study-Table.jpg 1200w, https:\/\/pulmonx.com\/wp-content\/uploads\/2019\/12\/Pulmonx-Zephyr-LIBERATE-Clinical-Study-Table-300x90.jpg 300w, https:\/\/pulmonx.com\/wp-content\/uploads\/2019\/12\/Pulmonx-Zephyr-LIBERATE-Clinical-Study-Table-1024x307.jpg 1024w, https:\/\/pulmonx.com\/wp-content\/uploads\/2019\/12\/Pulmonx-Zephyr-LIBERATE-Clinical-Study-Table-768x230.jpg 768w\" sizes=\"(max-width: 1200px) 100vw, 1200px\" \/> \n <\/div>\n <!-- \/image-wrap -->\n \n <\/div>\n<!-- \/module image --><!-- module text -->\n<div class=\"module module-text tb_7lx993 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <ul>\n<li class=\"p1\">Increased SAE rate with Zephyr Valve treatment compared to SoC in the short-term (first 45 days post-procedure)<\/li>\n<li class=\"p1\">Reduced SAE rate long-term (46 days to 12 months) with Zephyr Valve treatment compared to standard of care<\/li>\n<li class=\"p1\">5 of the 8 subjects experiencing a pneumothorax in the longer-term period had recently undergone a secondary bronchoscopy for valve replacement and\/or removal<\/li>\n<\/ul> <\/div>\n<\/div>\n<!-- \/module text --><!-- module divider -->\n<div class=\"module tf_mw module-divider tb_gb3g584 solid \" style=\"border-width: 1px;border-color: #3095b4;margin-top: 10px;margin-bottom: 40px;\" data-lazy=\"1\">\n <\/div>\n<!-- \/module divider -->\n<!-- module text -->\n<div class=\"module module-text tb_u6r8619 \" data-lazy=\"1\">\n <div class=\"tb_text_wrap\">\n <h2 class=\"p1\">Conclusion<\/h2>\n<p class=\"p1\">Zephyr<span class=\"s1\"><sup>\u00ae<\/sup><\/span>Endobronchial Valve treatment in carefully selected patients with little or no collateral ventilation in the target lobe provides clinically meaningful and statistically significant benefits in lung function, exercise tolerance, dyspnea, and quality of life over current standard of care medical therapy out to at least 12 months.<\/p>\n<p>Complications of the Zephyr Endobronchial Valve treatment can include but are not limited to pneumothorax, worsening of COPD symptoms, hemoptysis, pneumonia, dyspnea and, in rare cases, death.<\/p> <\/div>\n<\/div>\n<!-- \/module text --> <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n <\/div>\n<!--\/themify_builder_content-->","protected":false},"excerpt":{"rendered":"<p>A multicenter, multinational randomized controlled trial of Zephyr\u00ae Endobronchial Valves in patients with heterogenous emphysema and little to no collateral ventilation.<\/p>\n","protected":false},"author":2,"featured_media":91441,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[192],"tags":[],"class_list":["post-91440","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-clinical-studies-uk-en","has-post-title","has-post-date","has-post-category","has-post-tag","has-post-comment","has-post-author",""],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.1 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>LIBERATE Clinical Study for Zephyr Valves | Pulmonx<\/title>\n<meta name=\"description\" content=\"The LIBERATE clinical study is a multicenter, multinational randomized controlled trial of Zephyr\u00ae in patients with heterogenous emphysema.\" \/>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, 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