{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,7,26]],"date-time":"2026-07-26T00:21:02Z","timestamp":1785025262969,"version":"3.55.0"},"reference-count":29,"publisher":"Wiley","issue":"12","license":[{"start":{"date-parts":[[2023,9,20]],"date-time":"2023-09-20T00:00:00Z","timestamp":1695168000000},"content-version":"vor","delay-in-days":0,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc\/4.0\/"}],"content-domain":{"domain":["onlinelibrary.wiley.com"],"crossmark-restriction":true},"short-container-title":["Pediatric Pulmonology"],"published-print":{"date-parts":[[2023,12]]},"abstract":"<jats:title>Abstract<\/jats:title><jats:p><jats:bold>Introduction<\/jats:bold>: Growth impairment is a known adverse event (AE) of corticosteroids in children. This study aimed to assess the effect of once\u2010daily (QD) inhaled fluticasone furoate (FF) versus placebo on growth velocity over 1 year in prepubertal children with well\u2010controlled asthma.<\/jats:p><jats:p><jats:bold>Materials and Methods<\/jats:bold>: This randomized, double\u2010blind, parallel\u2010group, placebo\u2010controlled, multicenter study (NCT02889809) included prepubertal children, aged 5 to &lt;9 years (boys), and 5 to &lt;8 years (girls), with \u22656 months' asthma history. Children received inhaled placebo QD plus background open\u2010label montelukast QD for a 16\u2010week run\u2010in period and were then randomized 1:1 to receive inhaled FF 50\u2009\u03bcg QD or placebo QD (whilst continuing background open\u2010label montelukast) for a 52\u2010week treatment period. The primary endpoint was the difference in growth velocity (cm\/year) over the treatment period. Other growth endpoints were measured, as were incidence of AEs and asthma exacerbation. Growth analyses included all intent\u2010to\u2010treat (ITT) participants with \u22653 post\u2010randomization, on\u2010treatment clinic visit height assessments (GROWTH population).<\/jats:p><jats:p><jats:bold>Results<\/jats:bold>: Of 644 children in the run\u2010in period, 477 (mean age 6.2 years, 63% male) entered the 52\u2010week treatment period (ITT population: FF <jats:italic>N<\/jats:italic>\u2009=\u2009238, placebo <jats:italic>N<\/jats:italic>\u2009=\u2009239; GROWTH population: <jats:italic>N<\/jats:italic>\u2009=\u2009457 [FF <jats:italic>N<\/jats:italic>\u2009=\u2009231; placebo <jats:italic>N<\/jats:italic>\u2009=\u2009226]). The least\u2010squares mean difference in growth velocity for FF versus placebo was \u20130.160\u2009cm\/year (95% confidence interval: \u20130.462, 0.142). There were no new safety signals.<\/jats:p><jats:p><jats:bold>Conclusions<\/jats:bold>: Over 1 year, FF 50\u2009\u03bcg QD had a minimal effect on growth velocity versus placebo, with no new safety signals.<\/jats:p>","DOI":"10.1002\/ppul.26679","type":"journal-article","created":{"date-parts":[[2023,9,20]],"date-time":"2023-09-20T11:39:34Z","timestamp":1695209974000},"page":"3487-3497","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["A multicenter randomized, double\u2010blind, placebo\u2010controlled, parallel\u2010group study to evaluate the effects of a 1\u2010year regimen of orally inhaled fluticasone furoate 50\u2009\u00b5g once daily on growth velocity in prepubertal, pediatric participants with well\u2010controlled asthma"],"prefix":"10.1002","volume":"58","author":[{"ORCID":"https:\/\/orcid.org\/0000-0003-4625-4201","authenticated-orcid":false,"given":"Philippe","family":"Bareille","sequence":"first","affiliation":[{"name":"GSK Stevenage UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-8503-0510","authenticated-orcid":false,"given":"Varsha","family":"Imber","sequence":"additional","affiliation":[{"name":"GSK, Brentford London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Jodie","family":"Crawford","sequence":"additional","affiliation":[{"name":"GSK, Brentford London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Bernadetta","family":"Majorek\u2010Olechowska","sequence":"additional","affiliation":[{"name":"Alergo\u2010Med Specialist Medical Clinic Tarn\u00f3w Poland"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Zeina","family":"Karam\u2010Absi","sequence":"additional","affiliation":[{"name":"Parexel International Paris France"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sally","family":"Stone","sequence":"additional","affiliation":[{"name":"GSK, Brentford London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Ruby","family":"Birk","sequence":"additional","affiliation":[{"name":"GSK, Brentford London UK"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"311","published-online":{"date-parts":[[2023,9,20]]},"reference":[{"key":"e_1_2_10_2_1","doi-asserted-by":"publisher","DOI":"10.1183\/09031936.97.10071507"},{"key":"e_1_2_10_3_1","doi-asserted-by":"publisher","DOI":"10.1111\/j.1651-2227.1993.tb12814.x"},{"key":"e_1_2_10_4_1","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.303.6795.163"},{"key":"e_1_2_10_5_1","doi-asserted-by":"publisher","DOI":"10.2174\/1874306401408010066"},{"key":"e_1_2_10_6_1","unstructured":"US Food and Drug Administration. Guidance for industry: orally inhaled and intranasal corticosteroids: evaluation of the effects on growth in children.2007. 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