{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,9,29]],"date-time":"2026-09-29T21:26:02Z","timestamp":1790717162994,"version":"4.1.0"},"reference-count":32,"publisher":"Wiley","issue":"4","license":[{"start":{"date-parts":[[2018,5,29]],"date-time":"2018-05-29T00:00:00Z","timestamp":1527552000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/onlinelibrary.wiley.com\/termsAndConditions#vor"}],"funder":[{"name":"Lallemand Pharma AG"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Allergy Immunology"],"published-print":{"date-parts":[[2018,6]]},"abstract":"<jats:title>Abstract<\/jats:title>\n                  <jats:sec>\n                    <jats:title>Background<\/jats:title>\n                    <jats:p>\n                      Despite progress in asthma management, prevention of asthma exacerbation remains challenging in school\u2010aged children with allergic asthma. New therapeutic approaches are needed. Previously, a chemical bacterial lysate has been successfully used in preschool children to reduce wheezing attacks. We assessed the effect of Polyvalent Mechanical Bacterial Lysate (\n                      <jats:styled-content style=\"fixed-case\">PMBL<\/jats:styled-content>\n                      <jats:sup>\u00ae<\/jats:sup>\n                      ) Tablet on asthma clinical course and control in 6\u2010 to 16\u2010year\u2010old children with partly controlled or uncontrolled allergic asthma.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>\n                      A randomized, double\u2010blind, placebo\u2010controlled, parallel\u2010group study was performed in 152 patients exhibiting allergic asthma assigned to receive Placebo or\n                      <jats:styled-content style=\"fixed-case\">PMBL<\/jats:styled-content>\n                      <jats:sup>\u00ae<\/jats:sup>\n                      . Eligible patients underwent four visits during the 9\u2010month study. Asthma control level was assessed by\n                      <jats:styled-content style=\"fixed-case\">ACT<\/jats:styled-content>\n                      \/C\u2010\n                      <jats:styled-content style=\"fixed-case\">ACT<\/jats:styled-content>\n                      score.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>\n                      The main criterion was not achieved as\n                      <jats:styled-content style=\"fixed-case\">ACT<\/jats:styled-content>\n                      \/C\u2010\n                      <jats:styled-content style=\"fixed-case\">ACT<\/jats:styled-content>\n                      changes were similar in both groups at the end of the 3\u2010month treatment period. However, the mean number (\u00b1\n                      <jats:styled-content style=\"fixed-case\">SD<\/jats:styled-content>\n                      ) of asthma exacerbations was significantly lower with\n                      <jats:styled-content style=\"fixed-case\">PMBL<\/jats:styled-content>\n                      <jats:sup>\u00ae<\/jats:sup>\n                      Tablet than with Placebo at Week 12 (0.3\u00a0\u00b1\u00a00.6 vs 0.8\u00a0\u00b1\u00a01.1,\n                      <jats:italic>P\u00a0=\u00a0<\/jats:italic>\n                      .009) and over the total study period (1.1\u00a0\u00b1\u00a01.3 vs 1.9\u00a0\u00b1\u00a02.0,\n                      <jats:italic>P\u00a0=\u00a0<\/jats:italic>\n                      .01). Consistently, the mean number of days with exacerbation per patient was significantly lower with\n                      <jats:styled-content style=\"fixed-case\">PMBL<\/jats:styled-content>\n                      <jats:sup>\u00ae<\/jats:sup>\n                      Tablet (13.3\u00a0\u00b1\u00a011.2 vs 19.8\u00a0\u00b1\u00a015.7 over the whole study,\n                      <jats:italic>P\u00a0=\u00a0<\/jats:italic>\n                      .009). Treatment with\n                      <jats:styled-content style=\"fixed-case\">PMBL<\/jats:styled-content>\n                      <jats:sup>\u00ae<\/jats:sup>\n                      Tablet prolonged the time to second exacerbation by 55% (Hazard Ratio [\n                      <jats:styled-content style=\"fixed-case\">HR<\/jats:styled-content>\n                      ]=0.45; 95% Confidence Interval [\n                      <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>\n                      ] 0.27 to 0.77,\n                      <jats:italic>P\u00a0=\u00a0<\/jats:italic>\n                      .002) and to third exacerbation by 74% (\n                      <jats:styled-content style=\"fixed-case\">HR<\/jats:styled-content>\n                      =0.26; 95%\n                      <jats:styled-content style=\"fixed-case\">CI<\/jats:styled-content>\n                      0.12 to 0.58,\n                      <jats:italic>P\u00a0&lt;\u00a0<\/jats:italic>\n                      .001). No serious adverse event related to\n                      <jats:styled-content style=\"fixed-case\">PMBL<\/jats:styled-content>\n                      <jats:sup>\u00ae<\/jats:sup>\n                      Tablet administration was recorded.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusion<\/jats:title>\n                    <jats:p>\n                      Administration of\n                      <jats:styled-content style=\"fixed-case\">PMBL<\/jats:styled-content>\n                      <jats:sup>\u00ae<\/jats:sup>\n                      Tablet represents a safe and effective means for significantly reducing the rate of exacerbations in school\u2010aged allergic asthmatic children. (Eudra\n                      <jats:styled-content style=\"fixed-case\">CT<\/jats:styled-content>\n                      2013\u2010000737\u201012 and\n                      <jats:styled-content style=\"fixed-case\">NCT<\/jats:styled-content>\n                      02541331)\n                    <\/jats:p>\n                  <\/jats:sec>","DOI":"10.1111\/pai.12894","type":"journal-article","created":{"date-parts":[[2018,3,25]],"date-time":"2018-03-25T12:11:20Z","timestamp":1521979880000},"page":"394-401","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":40,"title":["Mechanical bacterial lysate administration prevents exacerbation in allergic asthmatic children\u2014The\n                    <scp>EOLIA<\/scp>\n                    study"],"prefix":"10.1111","volume":"29","author":[{"given":"Andrzej","family":"Emeryk","sequence":"first","affiliation":[{"name":"Department of Paediatric Pulmonology and Rheumatology University Children Hospital of Lublin  Lublin Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Malgorzata","family":"Bartkowiak\u2010Emeryk","sequence":"additional","affiliation":[{"name":"Department of Clinical Immunology Medical University of Lublin  Lublin Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zbigniew","family":"Raus","sequence":"additional","affiliation":[{"name":"LaserMed Diagnosis and Treatment Centre  Che\u0142m Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Fulvio","family":"Braido","sequence":"additional","affiliation":[{"name":"Allergy and Respiratory Diseases Department University of Genoa, IRCCS A.O.U San Martino\u2010 IST  Genova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Guido","family":"Ferlazzo","sequence":"additional","affiliation":[{"name":"Laboratory of Immunology and Biotherapy Department of Human Pathology University of Messina  Messina Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Giovanni","family":"Melioli","sequence":"additional","affiliation":[{"name":"Allergy and Respiratory Diseases Department University of Genoa, IRCCS A.O.U San Martino\u2010 IST  Genova Italy"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2018,5,29]]},"reference":[{"key":"e_1_2_7_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2011.10.024"},{"key":"e_1_2_7_3_1","doi-asserted-by":"publisher","DOI":"10.1186\/s12890-016-0172-x"},{"key":"e_1_2_7_4_1","doi-asserted-by":"publisher","DOI":"10.1186\/1471-2466-9-24"},{"key":"e_1_2_7_5_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2008.08.021"},{"key":"e_1_2_7_6_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2012.01.039"},{"key":"e_1_2_7_7_1","doi-asserted-by":"publisher","DOI":"10.1136\/thx.2005.045179"},{"key":"e_1_2_7_8_1","doi-asserted-by":"publisher","DOI":"10.1016\/S0140-6736(10)61380-3"},{"key":"e_1_2_7_9_1","doi-asserted-by":"publisher","DOI":"10.1586\/ers.09.60"},{"key":"e_1_2_7_10_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.jaci.2010.04.002"},{"key":"e_1_2_7_11_1","doi-asserted-by":"publisher","DOI":"10.1007\/s11882-013-0344-1"},{"key":"e_1_2_7_12_1","doi-asserted-by":"publisher","DOI":"10.1136\/thx.2005.042523"},{"key":"e_1_2_7_13_1","unstructured":"Global Initiative for Asthma \u2010 GINA.http:\/\/ginasthma.org\/. 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