Elvebakk Trude, Døllner Henrik, Partty Anna, Jartti Heidi, Vuorinen Tytti, Øymar Knut, Nerheim Silje, Moe Nina, Nordbø Svein Arne, Follestad Turid, Koski Johanna, Vollsæter Maria, Hofstad Anita, Klingenberg Claus, Leknessund Carina Bjørkvoll, Skjerven Håvard Ove, Risnes Kari, Söderhäll Cilla, Sissener Erle, Inchley Christopher Stephen, Konradsen Jon R, Jartti Tuomas
Children's Clinic, St Olav's Hospital HF, Trondheim, Norway
Children's Clinic, St Olav's Hospital HF, Trondheim, Norway.
BMJ Open. 2025 Jul 30;15(7):e103530. doi: 10.1136/bmjopen-2025-103530.
Asthma is a leading cause of morbidity and healthcare use among children. Risk factors of childhood asthma include atopic predisposition and severe wheezing episodes caused by rhinovirus infection in early life. In children with first-time rhinovirus-induced wheezing, we aim to study the response of a short corticosteroid treatment to prevent recurrent wheezing and asthma.
This is a double-blind, randomised, placebo-controlled, phase IV, international multicentre trial involving eight sites in Norway, Sweden and Finland. Two hundred and eighty 3-23 months old steroid-naïve children are randomised 1:1 to receive oral dexamethasone (0.3 mg/kg/day) versus placebo in 3 days for their first wheezing episode and rhinovirus infection. Rhinovirus is diagnosed with multiplex PCR. The two co-primary outcomes are time to next physician-confirmed wheezing episode, and time to asthma, within 24 months from inclusion. Asthma is defined as fulfilment of the 2007 National Asthma Education and Prevention Program-criteria for initiating asthma controller medication in children aged 0-4 years. Primary interaction analyses are age, gender, atopic predisposition, risk genotypes and viral co-detection. The optimal cut-off on the rhinovirus genome load used to define a true rhinovirus infection will be assessed by exploring interactions between rhinovirus genomic loads and study drug on the co-primary outcomes. Secondary outcomes are number of wheezing episodes, duration and severity of each wheezing episode, bronchial hyperreactivity, quality of life and safety (height/weight development) at 24 months from inclusion.
Rhinovirus positive children with acute wheezing fulfilling inclusion and exclusion criteria are enrolled after informed consent from both caregivers. This trial has received ethical approval from all sites. Results will be submitted to Competent Authorities and disseminated via peer-reviewed publications and conferences within paediatrics and other relevant fields. If proven effective, findings may be implemented directly into paediatric clinical guidelines.
NCT03889743.
哮喘是儿童发病和医疗保健使用的主要原因。儿童哮喘的危险因素包括特应性易感性和生命早期由鼻病毒感染引起的严重喘息发作。在首次因鼻病毒引起喘息的儿童中，我们旨在研究短期皮质类固醇治疗对预防复发性喘息和哮喘的反应。
这是一项双盲、随机、安慰剂对照的IV期国际多中心试验，涉及挪威、瑞典和芬兰的8个地点。280名3至23个月大、未使用过类固醇的儿童因首次喘息发作和鼻病毒感染，按1:1随机分组，在3天内接受口服地塞米松（0.3mg/kg/天）或安慰剂治疗。通过多重聚合酶链反应诊断鼻病毒。两个共同主要结局是自纳入起24个月内至下一次医生确认的喘息发作的时间，以及至哮喘的时间。哮喘定义为符合2007年国家哮喘教育和预防计划中0至4岁儿童启动哮喘控制药物治疗的标准。主要交互分析因素为年龄、性别、特应性易感性、风险基因型和病毒合并检测情况。将通过探索鼻病毒基因组载量与研究药物在共同主要结局上的交互作用，评估用于定义真正鼻病毒感染的鼻病毒基因组载量的最佳临界值。次要结局包括自纳入起24个月时的喘息发作次数、每次喘息发作的持续时间和严重程度、支气管高反应性、生活质量以及安全性（身高/体重发育情况）。
符合纳入和排除标准的急性喘息且鼻病毒检测呈阳性的儿童，在获得其照料者的知情同意后入组。本试验已获得所有研究地点的伦理批准。研究结果将提交给主管部门，并通过同行评审出版物以及儿科学和其他相关领域的会议进行传播。如果被证明有效，研究结果可能会直接纳入儿科临床指南。
NCT03889743。
