Yun Kirby Suyong, Zhu Chang-Qing, Kerwin Edward M, Stanford Richard H, Georges George
a 1 GSK, Research Triangle Park , North Carolina , USA.
b 2 GSK, Uxbridge , Middlesex , United Kingdom.
COPD. 2016;13(2):167-75. doi: 10.3109/15412555.2015.1057274. Epub 2015 Oct 30.
Patients' preference is an important factor in selecting an inhaler treatment for COPD. The DISKUS® dry powder inhaler (DPI), which has been available to deliver several COPD medications for a decade, and the ELLIPTA® DPI, developed for the delivery of newer once-daily medications for patients with COPD, were studied in terms of patient preference and inhaler-specific attributes. We conducted a randomized, open-label, crossover study in patients with COPD. Patients used placebo ELLIPTA DPI once daily and placebo DISKUS DPI twice daily, for ∼1 week each, while continuing their COPD medications. Endpoints were: inhaler preference based on size of the numbers on the dose-counter (primary); the number of steps needed and inhaler size (secondary); and based on comfort of the mouthpiece, ease of opening, overall preference, and dosing regimen preference ('other'). Safety assessments included adverse events (AEs). A total of 287 patients were randomized. A significantly (p < 0.001) larger proportion of patients preferred the ELLIPTA DPI over DISKUS DPI for each of the tested attributes and overall, and preferred once-daily over twice-daily dosing. AEs were reported for 36 patients (13%); one (dry mouth) was considered to be related to the placebo-containing DISKUS DPI. Three patients had five non-fatal serious AEs, none were deemed inhaler-related. This study demonstrated that more patients with COPD preferred five specific inhaler attributes of the ELLIPTA DPI over DISKUS DPI and overall, and preferred once-daily versus twice-daily dosing. Safety profiles were consistent with those expected for COPD.
患者偏好是为慢性阻塞性肺疾病（COPD）选择吸入器治疗的一个重要因素。已上市十年用于递送多种COPD药物的都保®（DISKUS®）干粉吸入器（DPI），以及为向COPD患者递送新型每日一次药物而研发的易纳器®（ELLIPTA®）DPI，就患者偏好和吸入器特定属性进行了研究。我们对COPD患者开展了一项随机、开放标签、交叉研究。患者每天使用一次安慰剂易纳器DPI，每天使用两次安慰剂都保DPI，每次约1周，同时继续服用其COPD药物。终点指标为：基于剂量计数器上数字大小的吸入器偏好（主要指标）；所需步骤数和吸入器尺寸（次要指标）；以及基于吸嘴舒适度、开启难易程度、总体偏好和给药方案偏好（“其他”）。安全性评估包括不良事件（AE）。共有287例患者被随机分组。对于每个测试属性以及总体而言，明显更多比例的患者（p < 0.001）更喜欢易纳器DPI而非都保DPI，并且更喜欢每日一次给药而非每日两次给药。36例患者（13%）报告了AE；其中1例（口干）被认为与含安慰剂的都保DPI有关。3例患者发生了5起非致命严重AE，均未被认为与吸入器相关。这项研究表明，更多COPD患者在五个特定吸入器属性方面更喜欢易纳器DPI而非都保DPI，并且总体上更喜欢每日一次给药而非每日两次给药。安全性特征与COPD预期的特征一致。
