van der Palen Job, Slade David, Rehal Sunita, Verma Manish, Plank Maximilian
Department of Epidemiology, Medisch Spectrum Twente and Section Cognition, Data and Education, Faculty of Behavioral Science, University of Twente, Enschede, the Netherlands.
GSK, Research Triangle Park, NC, USA.
Respir Med. 2022 Dec;205:107031. doi: 10.1016/j.rmed.2022.107031. Epub 2022 Oct 28.
Many patients with asthma make errors using inhalers, affecting the amount of medication received. Previous evidence demonstrated that patients with asthma or chronic obstructive pulmonary disease make fewer critical errors with the ELLIPTA inhaler after reading the patient information leaflet (PIL) versus other dry powder inhalers. We assessed errors made by patients with asthma using placebo ELLIPTA or BREEZHALER inhalers.
This randomized, multicenter, open-label placebo inhaler-handling study (ClinicalTrials.gov: NCT04813354) with 2x2 complete block crossover design was conducted at three centers in the Netherlands and enrolled patients aged ≥18 years with mild-to-moderate asthma. Inclusion criteria were inhaler use for ≥12 weeks prior to enrollment and naivety to ELLIPTA and BREEZHALER inhalers. Patients were randomized to ELLIPTA or BREEZHALER inhaler first and were assessed for errors in use of both inhalers after 1) reading PIL instructions, 2) receiving further instruction from a healthcare professional (HCP) if they made an error.
114 patients with asthma (57% female; mean age of 55.3 years) were assessed. After reading the PIL, 6% of patients made ≥1 critical error with ELLIPTA versus 26% with BREEZHALER (odds ratio [OR]: 0.11 [95% confidence interval (CI): 0.01-0.40]; p < 0.001). With ELLIPTA, 27% of patients made ≥1 overall error after reading the PIL versus 41% with BREEZHALER (OR: 0.25 [95% CI: 0.03-0.74]; p = 0.005). Fewer patients required HCP instruction with ELLIPTA than BREEZHALER (25% versus 32%).
Fewer patients made critical and overall errors using the ELLIPTA inhaler versus BREEZHALER after reading the PIL.
许多哮喘患者在使用吸入器时会出现操作失误，影响药物吸入量。先前的证据表明，哮喘或慢性阻塞性肺疾病患者在阅读患者信息说明书（PIL）后，使用ELLIPTA吸入器时出现的严重失误比使用其他干粉吸入器时少。我们评估了使用安慰剂ELLIPTA或BREEZHALER吸入器的哮喘患者所犯的错误。
这项随机、多中心、开放标签的安慰剂吸入器操作研究（ClinicalTrials.gov：NCT04813354）采用2×2完全区组交叉设计，在荷兰的三个中心进行，纳入年龄≥18岁的轻至中度哮喘患者。纳入标准为在入组前使用吸入器≥12周，且对ELLIPTA和BREEZHALER吸入器不熟悉。患者首先被随机分配到ELLIPTA或BREEZHALER吸入器组，并在以下情况下评估两种吸入器的使用错误：1）阅读PIL说明书后；2）如果他们出现错误，接受医护人员（HCP）的进一步指导后。
评估了114例哮喘患者（57%为女性；平均年龄55.3岁）。阅读PIL后，使用ELLIPTA的患者中有6%出现≥1次严重失误，而使用BREEZHALER的患者中有26%出现严重失误（优势比[OR]：0.11[95%置信区间（CI）：0.01-0.40]；p<0.001）。使用ELLIPTA时，阅读PIL后27%的患者出现≥1次总体失误，而使用BREEZHALER的患者中这一比例为41%（OR：0.25[95%CI：0.03-0.74]；p=0.005）。与BREEZHALER相比，需要HCP指导的ELLIPTA患者更少（25%对32%）。
阅读PIL后，使用ELLIPTA吸入器的患者出现严重和总体失误的情况比使用BREEZHALER吸入器的患者少。
