■分散式临床试验，与试验相关的活动发生在传统临床地点以外的其他地点(如参与者之家，当地医疗机构)，有可能改善时间和/或距离限制可能阻碍参与的人的试验机会。沙丁胺醇-布地奈德180/160µg加压计量吸入器（pMDI）已被FDA批准用于根据需要治疗或预防支气管收缩，并降低18岁或以上哮喘患者恶化的风险。BATURA(NCT05505734)是一项完全分散的研究，调查轻度哮喘参与者的沙丁胺醇-布地奈德按需治疗.
■BATURA是一个完全分散的，阶段3b,随机化，双盲,事件驱动的加重研究在美国进行。年龄≥12岁的参与者，按需使用短效β2激动剂（SABA），单独或与低剂量吸入皮质类固醇或白三烯受体拮抗剂维持，按1：1随机分配至沙丁胺醇-布地奈德180/160µg或沙丁胺醇180µgpMDI，最长52周（最少12周）。参与者继续他们目前的维持治疗，如果适用。参与者必须在2周前使用SABA≥2天，并且在筛选和随机分组时哮喘损害风险问卷得分≥2。所有与审判有关的访问，包括筛查和同意，是虚拟进行的，研究药物直接运送到每个参与者的住所。主要目的是评估按需使用沙丁胺醇-布地奈德与沙丁胺醇对重度哮喘急性发作风险的疗效。通过严重哮喘急性发作时间（主要终点）来衡量。次要终点包括严重哮喘急性发作的年率和全身皮质类固醇总暴露。通过连接到研究药物pMDI的Hailie传感器捕获研究药物的使用。预期样本量为2500名参与者。
■BATURA根据需要评估轻度哮喘参与者的沙丁胺醇-布地奈德。分散的研究模型使试验能够从研究地点转移到参与者家中，减少参与者的负担和改善访问。
UNASSIGNED: Decentralized clinical trials, where trial-related activities occur at locations other than traditional clinical sites(eg participant homes, local healthcare facilities), have the potential to improve trial access for people for whom time and/or distance constraints may impede participation. Albuterol-budesonide 180/160 µg pressurized metered-dose inhaler (pMDI) is FDA approved for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in patients with asthma 18 years or older. BATURA (NCT05505734) is a fully decentralized study, investigating as-needed albuterol-budesonide in participants with mild asthma.
UNASSIGNED: BATURA is a fully decentralized, phase 3b, randomized, double-blind, event-driven exacerbation study conducted in the United States. Participants aged ≥12 years using as-needed short-acting β2-agonist (SABA), alone or with low-dose inhaled corticosteroid or leukotriene receptor antagonist maintenance, are randomized 1:1 to as-needed albuterol-budesonide 180/160 µg or albuterol 180 µg pMDI for up to 52 weeks (minimum 12 weeks). Participants continue their current maintenance therapy, if applicable. Participants must have used SABA for ≥2 days in the 2 weeks pre-enrollment and have an Asthma Impairment Risk Questionnaire score ≥2 at screening and randomization. All trial-related visits, including screening and consent, are conducted virtually, with study medication shipped directly to each participant\'s residence. The primary objective is to evaluate the efficacy of as-needed albuterol-budesonide versus albuterol on severe asthma exacerbation risk, measured by time-to-first severe asthma exacerbation (primary endpoint). Secondary endpoints include annualized rate of severe asthma exacerbation and total systemic corticosteroid exposure. Study medication use is captured via a Hailie sensor attached to the study medication pMDI. The intended sample size is 2500 participants.
UNASSIGNED: BATURA evaluates as-needed albuterol-budesonide in participants with mild asthma. The decentralized study model enables the trial to move out of research sites into participant homes, reducing participant burden and improving access.
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