START CARE: a protocol for an RCT of step-wise budesonide-formoterol reliever-based treatment in children

Tasmin Barry, M. Holliday, J. Sparks, Rowan Biggs, Atalie Colman, Rebekah Lamb, K. Oldfield, Nick Shortt, Kyley Kerse, John Martindale, A. Eathorne, Michaela Walton, Bianca Black, M. Harwood, P. Bruce, Ruth Semprini, Andrew Bush, Louise J. Fleming, Catherine A. Byrnes, David McNamara, L. Hatter, Stuart R. Dalziel, M. Weatherall, R. Beasley
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Abstract

Asthma is the most common chronic childhood respiratory condition globally. Inhaled corticosteroid (ICS)-formoterol reliever-based regimens reduce the risk of asthma exacerbations compared with conventional short-acting beta2-agonist (SABA) reliever-based regimens in adults and adolescents. The current limited evidence for anti-inflammatory reliever (AIR) therapy in children means it is unknown whether these findings are also applicable to children. High-quality randomised controlled trials (RCTs) are needed.The study aim is to determine the efficacy and safety of budesonide-formoterol reliever alone or maintenance and reliever therapy (MART) compared with standard therapy: budesonide or budesonide-formoterol maintenance, both with terbutaline reliever, in children aged 5 to 11 years with mild, moderate and severe asthma.A 52 week, multicentre, open-label, parallel group, phase III, two-sided superiority RCT will recruit 400 children aged 5 to 11 years with asthma. Participants will be randomised 1:1 to either budesonide-formoterol 100/6 µg Turbuhaler reliever alone or MART; or budesonide or budesonide-formoterol Turbuhaler maintenance, with terbutaline Turbuhaler reliever. The primary outcome is moderate and severe asthma exacerbations as rate per participant per year. Secondary outcomes are asthma control, lung function, exhaled nitric oxide and treatment step change. Assessment of Turbuhaler technique and cost-effectiveness analysis are also planned.This will be the first RCT to compare the efficacy and safety of a step-wise budesonide-formoterol reliever alone or MART regimen with conventional inhaled ICS or ICS-long-acting beta-agonist (LABA) maintenance plus SABA reliever in children. The results will provide a much-needed evidence base for the treatment of asthma in children.
START CARE:基于布地奈德-福莫特罗缓解剂的儿童分步治疗 RCT 方案
哮喘是全球最常见的儿童慢性呼吸系统疾病。在成人和青少年中,吸入皮质类固醇(ICS)-福莫特罗缓解剂疗法与传统的短效β2-激动剂(SABA)缓解剂疗法相比,可降低哮喘加重的风险。目前,儿童抗炎缓解剂(AIR)疗法的证据有限,因此尚不清楚这些研究结果是否也适用于儿童。该研究旨在确定布地奈德-福莫特罗缓解剂单独疗法或维持和缓解剂疗法(MART)与标准疗法(布地奈德或布地奈德-福莫特罗维持疗法,两者均与特布他林缓解剂)相比,对 5-11 岁轻度、中度和重度哮喘儿童的疗效和安全性。这项为期 52 周的多中心、开放标签、平行分组、III 期、双侧优效 RCT 将招募 400 名 5-11 岁的哮喘患儿。参与者将按 1:1 的比例被随机分配到单独使用布地奈德-福莫特罗 100/6 µg Turbuhaler 缓解剂或 MART;或布地奈德或布地奈德-福莫特罗 Turbuhaler 维持治疗,同时使用特布他林 Turbuhaler 缓解剂。主要结果是中度和重度哮喘加重,以每位参与者每年的发生率计算。次要结果是哮喘控制、肺功能、呼出一氧化氮和治疗步骤变化。这将是首个比较单独使用阶梯式布地奈德-福莫特罗缓解剂或 MART 方案与传统吸入 ICS 或 ICS-长效 β-受体激动剂 (LABA) 维持治疗加 SABA 缓解剂对儿童的疗效和安全性的 RCT 研究。研究结果将为儿童哮喘的治疗提供急需的证据基础。
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