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40 岁或以上、初次使用吸入装置的日本志愿者对 ELLIPTA®干粉吸入器相对于常用单剂量胶囊干粉吸入器的使用偏好。

Ease-of-use preference for the ELLIPTA® dry powder inhaler over a commonly used single-dose capsule dry powder inhaler by inhalation device-naïve Japanese volunteers aged 40 years or older.

机构信息

Department of Respiratory Internal Medicine, St Marianna University School of Medicine, Yokohama City Seibu Hospital, Yokohama, Kanagawa, Japan.

MA Respiratory Department, Development and Medical Affairs Unit, GlaxoSmithKline KK, Tokyo, Japan.

出版信息

Int J Chron Obstruct Pulmon Dis. 2014 Dec 11;9:1365-75. doi: 10.2147/COPD.S72762. eCollection 2014.

Abstract

BACKGROUND

In patients receiving inhaled medication, dissatisfaction with and difficulty in using the inhaler can affect treatment adherence. The incidence of handling errors is typically higher in the elderly than in younger people. The aim of the study was to assess inhaler preference for and handling errors with the ELLIPTA® dry powder inhaler (DPI), (GSK), compared with the established BREEZHALER™, a single-dose capsule DPI (Novartis), in inhalation device-naïve Japanese volunteers aged ≥40 years.

METHODS

In this open-label, nondrug interventional, crossover DPI preference study comparing the ELLIPTA DPI and BREEZHALER, 150 subjects were randomized to handle the ELLIPTA or BREEZHALER DPIs until the point of inhalation, without receiving verbal or demonstrative instruction (first attempt). Subjects then crossed over to the other inhaler. Preference was assessed using a self-completed questionnaire. Inhaler handling was assessed by a trained assessor using a checklist. Subjects did not inhale any medication in the study, so efficacy and safety were not measured.

RESULTS

The ELLIPTA DPI was preferred to the BREEZHALER by 89% of subjects (odds ratio [OR] 70.14, 95% confidence interval [CI] 33.69-146.01; P-value not applicable for this inhaler) for ease of use, by 63% of subjects (OR 2.98, CI 1.87-4.77; P<0.0001) for ease of determining the number of doses remaining in the inhaler, by 91% for number of steps required, and by 93% for time needed for handling the inhaler. The BREEZHALER was preferred to the ELLIPTA DPI for comfort of the mouthpiece by 64% of subjects (OR 3.16, CI 1.97-5.06; P<0.0001). The incidence of handling errors (first attempt) was 11% with ELLIPTA and 68% with BREEZHALER; differences in incidence were generally similar when analyzed by age (< or ≥65 years) or sex.

CONCLUSION

These data, obtained in an inhalation device-naïve population, suggest that the ELLIPTA DPI is preferred to an established alternative based on its ease-of-use features and is associated with fewer handling errors.

摘要

背景

在接受吸入性药物治疗的患者中,对吸入器的不满和使用困难可能会影响治疗依从性。处理错误的发生率在老年人中通常高于年轻人。本研究的目的是评估在未使用过吸入装置的≥40 岁日本志愿者中,与已上市的单剂量胶囊型干粉吸入器(Novartis 公司的 BREEZHALER)相比,新型干粉吸入器(GSK 公司的 ELLIPTA)在吸入器选择和处理错误方面的差异。

方法

这是一项开放性、非药物干预、交叉干粉吸入器偏好研究,比较了 ELLIPTA 干粉吸入器和 BREEZHALER。150 名受试者被随机分配至处理 ELLIPTA 或 BREEZHALER 干粉吸入器,直至可吸入状态,在此过程中不接受口头或示范指导(首次尝试)。随后受试者交叉使用另一种吸入器。使用自填问卷评估偏好。由经过培训的评估员使用检查表评估吸入器的使用情况。本研究中受试者未吸入任何药物,因此未测量疗效和安全性。

结果

89%(优势比[OR]70.14,95%置信区间[CI]33.69-146.01;该吸入器无适用的 P 值)的受试者认为 ELLIPTA 干粉吸入器易于使用,63%(OR 2.98,CI 1.87-4.77;P<0.0001)的受试者认为该吸入器易于确定剩余的剂量数,91%的受试者认为其所需步骤更少,93%的受试者认为其操作方便。64%(OR 3.16,CI 1.97-5.06;P<0.0001)的受试者认为 BREEZHALER 的吸嘴更舒适。首次尝试时,ELLIPTA 干粉吸入器的处理错误发生率为 11%,BREEZHALER 为 68%;按年龄(<65 岁或≥65 岁)或性别分析,发生率的差异基本相似。

结论

这些数据来自未使用过吸入装置的人群,表明 ELLIPTA 干粉吸入器基于其易用性特点更受偏爱,且与处理错误发生率较低有关。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/fab8/4267517/d2d786ea6768/copd-9-1365Fig1.jpg

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