Respiratory Disease and Lung Function Unit, Department of Medicine and Surgery, University of Parma, Parma, Italy.
Department of Pulmonology, Medical Faculty, Celal Bayar University, Manisa, Turkey.
BMC Pulm Med. 2021 Feb 25;21(1):65. doi: 10.1186/s12890-021-01430-9.
Inhaler selection is important when managing respiratory conditions; a patient's inhalation technique should be appropriate for the selected device, and patients should ideally be able to use a device successfully regardless of disease severity. The NEXThaler is a multidose dry-powder inhaler with a breath-actuated mechanism (BAM) and dose counter that activates only following inhalation, so effectively an 'inhalation counter'. We assessed inspiratory flow through the NEXThaler in two studies and examined whether inhalation triggered the BAM.
The two studies were open-label, single-arm, and single visit. One study recruited patients with asthma aged ≥ 18 years; the other recruited patients with chronic obstructive pulmonary disease (COPD) aged ≥ 40 years. All patients inhaled twice through a placebo NEXThaler. The inspiratory profile through the device was assessed for each inhalation using acoustic monitoring, with flow at and time to BAM firing, peak inspiratory flow (PIF), and total inhalation time assessed.
A total of 40 patients were enrolled in the asthma study: 20 with controlled asthma and 20 with partly controlled/uncontrolled asthma. All patients were able to trigger the BAM, as evidenced by the inhalation counter activating on closing the device. Mean flow at BAM firing following first inhalation was 35.0 (range 16.3-52.3) L/min; mean PIF was 64.6 (35.0-123.9) L/min. A total of 72 patients were enrolled in the COPD study, with data analysed for 69 (mean forced expiratory volume in 1 s 48.7% predicted [17-92%]). As with the asthma study, all patients, regardless of airflow limitation, were able to trigger the BAM. Mean flow at BAM firing following first inhalation was 41.9 (26.6-57.1) L/min; mean PIF was 68.0 (31.5-125.4) L/min. Device usability was rated highly in both studies, with 5 min sufficient to train the patients, and a click heard shortly after inhalation in all cases (providing feedback on BAM firing).
Inhalation flows triggering the BAM in the NEXThaler were similar between patients with controlled and partly controlled/uncontrolled asthma, and were similar across COPD airflow limitation. All enrolled patients were able to activate the device.
在管理呼吸系统疾病时，吸入器的选择很重要；患者的吸入技术应适合所选设备，并且无论疾病严重程度如何，患者都应能够成功使用设备。NEXThaler 是一种具有呼吸触发机制（BAM）和剂量计数器的多剂量干粉吸入器，只有在吸入后才会激活剂量计数器，因此有效地成为“吸入计数器”。我们在两项研究中评估了通过 NEXThaler 的吸气流量，并检查了吸入是否触发了 BAM。
这两项研究均为开放标签、单臂、单次就诊。一项研究招募了年龄≥18 岁的哮喘患者；另一项研究招募了年龄≥40 岁的慢性阻塞性肺疾病（COPD）患者。所有患者均通过安慰剂 NEXThaler 吸入两次。使用声学监测评估每次吸入通过装置的吸气情况，评估吸入流量和 BAM 触发时间、吸气峰流速（PIF）和总吸气时间。
共有 40 名哮喘患者参加了这项研究：20 名哮喘控制良好，20 名哮喘部分控制/未控制。所有患者均能够触发 BAM，因为关闭装置时吸入计数器会激活。第一次吸入后 BAM 触发时的平均流量为 35.0（范围 16.3-52.3）L/min；平均 PIF 为 64.6（35.0-123.9）L/min。共有 72 名 COPD 患者参加了这项研究，对 69 名患者（平均用力呼气量 1 秒预测值 48.7%[17-92%]）进行了数据分析。与哮喘研究一样，所有患者，无论气流受限程度如何，均能够触发 BAM。第一次吸入后 BAM 触发时的平均流量为 41.9（26.6-57.1）L/min；平均 PIF 为 68.0（31.5-125.4）L/min。两项研究均高度评价了设备的可用性，患者在 5 分钟内即可接受培训，并且在所有情况下吸入后不久都会听到咔嗒声（提供 BAM 触发反馈）。
在哮喘控制良好和部分控制/未控制的患者以及 COPD 气流受限患者中，触发 NEXThaler 中 BAM 的吸气流量相似。所有入组患者均能够激活设备。
