Inhalation Consultancy Ltd., Leeds, United Kingdom.
Bradford Institute for Health Research, Bradford Teaching Hospitals NHS Foundation Trust, Bradford, United Kingdom.
J Aerosol Med Pulm Drug Deliv. 2022 Jun;35(3):166-177. doi: 10.1089/jamp.2021.0031. Epub 2021 Dec 29.
The Digihaler is a Food and Drug Administration-approved, digital multidose dry powder inhaler with an integrated electronic module that provides patients and health care professionals with feedback on inhalation parameters, including usage, adherence, and technique. This study compared inhalation parameters measured using the Digihaler with readings made simultaneously using an inhalation profile recorder (IPR). This single-visit, open-label study enrolled children (4-17 years) and adults (18-55 years) with asthma, and adults (≥55 years) with chronic obstructive pulmonary disease (COPD). Participants made three separate inhalations using an empty Digihaler device, each measured simultaneously by the Digihaler and IPR. Inhalation profiles were downloaded from the devices at the end of the study. Inhalation parameters measured included peak inspiratory flow (PIF) and inhaled volume (inhV). The profile with the highest PIF and corresponding IPR profile were analyzed. Overall, 150 participants were enrolled; inhalation data were available for 148 (50 children and 49 adults with asthma, and 49 with COPD). Mean (standard deviation [SD]) age was 39.1 (24.5) years; 51% of participants were male. Overall mean (SD) PIFs as measured by the Digihaler and IPR were 70.62 (17.73) L/min and 72.55 (19.42) L/min, respectively, with a mean percentage difference of -1.75% (95% confidence interval [CI]: -3.64 to 0.15). Mean percentage differences between the Digihaler and IPR measurements of PIF ranged from -2.97% among adults with COPD to 0.16% among children with asthma. Overall mean (SD) inhV for the Digihaler and IPR were 1.57 (0.69) L and 1.67 (0.73) L, respectively, with a mean percentage difference of -6.11 (95% CI: -8.08 to -4.13). There was a strong correlation between PIF and inhV measurements taken by the Digihaler and those taken by the IPR (Spearman's correlation coefficient = 0.96). Our findings confirm the ability of the Digihaler to provide accurate measurement of inhalation parameters when used by patients.
Digihaler 是一种获得美国食品药品监督管理局批准的数字型多剂量干粉吸入器，带有集成电子模块，可为患者和医护人员提供吸入参数的反馈，包括使用、依从性和技术。这项研究比较了 Digihaler 测量的吸入参数与同时使用吸入特性记录仪（IPR）获得的读数。这项单访、开放性研究纳入了哮喘患儿（4-17 岁）和成年患者（18-55 岁）以及 COPD 成年患者（≥55 岁）。参与者使用空的 Digihaler 设备进行了三次单独的吸入，每次吸入均由 Digihaler 和 IPR 同时测量。研究结束时从设备上下载了吸入谱。测量的吸入参数包括吸气峰流速（PIF）和吸入量（inhV）。分析了具有最高 PIF 的谱和相应的 IPR 谱。共有 150 名参与者入组；148 名（50 名儿童和 49 名哮喘成年患者，49 名 COPD 成年患者）可提供吸入数据。平均（标准偏差 [SD]）年龄为 39.1（24.5）岁；51%的参与者为男性。Digihaler 和 IPR 测量的总体平均（SD）PIF 分别为 70.62（17.73）L/min 和 72.55（19.42）L/min，平均百分比差异为-1.75%（95%置信区间 [CI]：-3.64 至 0.15）。Digihaler 和 IPR 测量的 PIF 之间的平均百分比差异范围为 COPD 成年患者的-2.97%至哮喘儿童的 0.16%。Digihaler 和 IPR 的总体平均（SD）inhV 分别为 1.57（0.69）L 和 1.67（0.73）L，平均百分比差异为-6.11%（95%CI：-8.08 至-4.13）。Digihaler 和 IPR 测量的 PIF 和 inhV 之间存在很强的相关性（Spearman 相关系数=0.96）。我们的发现证实，当患者使用时，Digihaler 能够准确测量吸入参数。
