Bruce Pepa, Hatter Lee, Houghton Claire, Kearns Ciléin, Holliday Mark, Anderson Augustus J, Eathorne Allie, Martindale John, Semprini Alex, Weatherall Mark, Pavord Ian, Harrison Tim, Papi Alberto, Horne Rob, Beasley Richard
Medical Research Institute of New Zealand, Wellington, New Zealand.
Department of Medicine, University of Otago, Wellington, New Zealand.
ERJ Open Res. 2023 Sep 25;9(5). doi: 10.1183/23120541.00239-2023. eCollection 2023 Sep.
The stepwise approach to long-term asthma management, which traditionally incorporates short-acting β-agonist reliever therapy, has been a core feature of asthma guidelines for over 30 years. There have been no studies, however, directly investigating the use of an entire guideline-recommended track. Recently, inhaled corticosteroid-formoterol has been recommended as the preferred reliever therapy in adult asthma, in accordance with a stepwise "Anti-Inflammatory Reliever" (AIR) treatment track.
The aim of this study was to evaluate the AIR stepwise approach recommended by the New Zealand adolescent and adult asthma guidelines, in combination with a novel algorithm for transitioning between treatment steps.
This 52-week, open-label, single-group study will recruit 100 adults aged 18 to 75 years with mild, moderate and moderate-severe asthma (ACTRN12620001010987). Participants will be allocated to budesonide-formoterol 200/6 µg, one actuation as needed (Step 1), one actuation twice daily and as needed (Step 2), or two actuations twice daily and one as needed (Step 3). Treatment steps will be adjusted throughout the study, in response to reliever use and asthma attacks, according to a stepwise AIR algorithm. Following a 26-week period of investigator-led transitions, participants will adjust their own treatment step. The primary outcome is participant satisfaction as measured by the Global Satisfaction score of the Treatment Satisfaction Questionnaire for Medication. Secondary outcomes will assess efficacy and safety, and describe patterns of medication use and participant flow through the treatment steps.
This is the first trial to assess the AIR treatment track and algorithm. The results will provide knowledge to guide the clinical use of this approach.
长期哮喘管理的逐步治疗方法，传统上包括短效β受体激动剂缓解治疗，30多年来一直是哮喘指南的核心特征。然而，尚无研究直接调查整个指南推荐治疗路径的使用情况。最近，根据逐步的“抗炎缓解剂”（AIR）治疗路径，吸入性糖皮质激素-福莫特罗已被推荐为成人哮喘的首选缓解治疗药物。
本研究旨在评估新西兰青少年和成人哮喘指南推荐的AIR逐步治疗方法，并结合一种用于在治疗步骤之间转换的新算法。
这项为期52周的开放标签单组研究将招募100名年龄在18至75岁之间的轻、中、中度至重度哮喘成人患者（澳大利亚和新西兰临床试验注册号：12620001010987）。参与者将被分配使用布地奈德-福莫特罗200/6μg，按需吸入1次（第1步），每日2次按需吸入1次（第2步），或每日2次按需吸入2次且按需吸入1次（第3步）。在整个研究过程中，将根据逐步的AIR算法，根据缓解药物的使用情况和哮喘发作情况调整治疗步骤。在经过26周由研究者主导的转换期后，参与者将自行调整治疗步骤。主要结局是通过药物治疗满意度问卷的总体满意度得分来衡量的参与者满意度。次要结局将评估疗效和安全性，并描述药物使用模式以及参与者在各治疗步骤中的流程。
这是第一项评估AIR治疗路径和算法的试验。研究结果将为指导该方法的临床应用提供知识依据。
