{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,2]],"date-time":"2026-07-02T23:45:00Z","timestamp":1783035900460,"version":"3.54.6"},"reference-count":27,"publisher":"Wiley","issue":"7","license":[{"start":{"date-parts":[[2024,1,12]],"date-time":"2024-01-12T00:00:00Z","timestamp":1705017600000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Develop Med Child Neuro"],"published-print":{"date-parts":[[2024,7]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:sec><jats:title>Aim<\/jats:title><jats:p>To investigate the efficacy, safety, and impact on quality of life (QoL)\u00a0of an oral formulation of 320\u2009\u03bcg\/mL glycopyrronium designed for children.<\/jats:p><\/jats:sec><jats:sec><jats:title>Method<\/jats:title><jats:p>A double\u2010blind, placebo\u2010controlled SALIVA (Sialanar plus orAl rehabiLitation against placebo plus oral rehabilitation for chIldren and adolescents with seVere sialorrhoeA and neurodisabilities) trial was conducted. Children (3\u201317\u2009years) with neurodisabilities and severe sialorrhoea (modified Teachers Drooling Scale\u2009\u22656) were randomized to 320\u2009\u03bcg\/mL glycopyrronium or placebo, in addition to non\u2010pharmacological standard care.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Of 87 participants, 44 were aged 10\u2009years or under and 43 had cerebral palsy. The primary endpoint, change in total Drooling Impact Scale (DIS) score from baseline to day 84, was significantly greater (improved) with 320\u2009\u03bcg\/mL glycopyrronium versus placebo (median [quartile 1, quartile 3] \u201329.5 [\u221244.5, 0] vs \u22121 [\u221216, 5]; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.001), an effect also observed at day 28 (median\u2009\u2212\u200925 vs \u22122; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.01). Significant reduction in bibs\/clothes used per day was seen with glycopyrronium versus placebo at day 84 (median\u2009\u2212\u20092 vs 0; <jats:italic>p<\/jats:italic>\u2009&lt;\u20090.01). Glycopyrronium significantly improved DIS items 9 and 10 related to the extent that drooling affects the child's and family's life (<jats:italic>p<\/jats:italic>\u2009\u2264\u20090.03). Adverse events were reported by 77.3% and 69.8% of children with glycopyrronium and placebo respectively; the most common treatment\u2010related adverse event was constipation (20.5% and 16.3%).<\/jats:p><\/jats:sec><jats:sec><jats:title>Interpretation<\/jats:title><jats:p>The formulation of 320\u2009\u03bcg\/mL glycopyrronium significantly improved drooling and reduced its impact on QoL, with good tolerability in children with neurodisabilities.<\/jats:p><\/jats:sec><jats:sec><jats:title>What this paper adds<\/jats:title><jats:p>\n<jats:list list-type=\"bullet\">\n<jats:list-item><jats:p>The formulation of 320\u2009\u03bcg\/mL glycopyrronium significantly improved Drooling Impact Scale score versus placebo at day 84.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>The formulation reduced the impact of drooling on the child's and family's quality of life.<\/jats:p><\/jats:list-item>\n<jats:list-item><jats:p>There were no safety or tolerability concerns with this specific formulation.<\/jats:p><\/jats:list-item>\n<\/jats:list><\/jats:p><\/jats:sec>","DOI":"10.1111\/dmcn.15841","type":"journal-article","created":{"date-parts":[[2024,1,12]],"date-time":"2024-01-12T15:14:11Z","timestamp":1705072451000},"page":"910-918","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":10,"title":["Glycopyrronium 320\u2009\u03bcg\/<scp>mL<\/scp> in children and adolescents with severe sialorrhoea and neurodisabilities: A randomized, double\u2010blind, placebo\u2010controlled trial"],"prefix":"10.1111","volume":"66","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-0740-4580","authenticated-orcid":false,"given":"Pierre","family":"Fayoux","sequence":"first","affiliation":[{"name":"Department of Paediatric Otolaryngology Head Neck Surgery Jeanne de Flandre Hospital  Lille France"},{"name":"ULR 2694 \u2010 METRICS: \u00c9valuation des technologies de sant\u00e9 et des pratiques m\u00e9dicales Universit\u00e9 de Lille  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