University of Twente, Department of Research Methodology, Measurement and Data Analysis, Enschede, The Netherlands.
Expert Opin Drug Deliv. 2013 Aug;10(8):1023-31. doi: 10.1517/17425247.2013.808186. Epub 2013 Jun 8.
To assess preference, satisfaction and critical errors with a novel, breath-actuated, multi-dose dry powder inhaler (DPI; Genuair®/Pressair™), versus a widely used, single-dose DPI (HandiHaler®) in patients with moderate-to-severe chronic obstructive pulmonary disease.
In this randomised, open-label, multicentre, cross-over study, patients (aged ≥ 40 years) inhaled placebo once daily through both inhalers for 2 weeks in addition to current medication. The primary end point was percentage of patients who preferred Genuair to HandiHaler. Overall patient satisfaction (5-point scale: 1 = very dissatisfied; 5 = very satisfied), critical errors and willingness to continue using each inhaler (0 = not willing; 100 = definitely willing) were assessed.
Of 130 patients randomised, 105 were included in the intent-to-treat population (71.4% male; mean age 65.7 years). After 2 weeks, significantly more patients preferred Genuair than HandiHaler (79.1 vs 20.9%; p < 0.0001). Overall satisfaction scores (4.6 vs 3.8; p < 0.0001) and willingness to continue use scores (84.0 vs 62.5; p < 0.0001) were significantly higher with Genuair versus HandiHaler. Significantly fewer patients made ≥ 1 critical error with Genuair only compared with HandiHaler only (2.9 vs 19.0%; p < 0.0001).
After 2 weeks' practice, patients preferred and were more willing to continue using Genuair than HandiHaler. Genuair was associated with higher patient satisfaction and fewer critical errors than HandiHaler.
评估新型、呼吸驱动、多剂量干粉吸入器(DPI;Genuair®/Pressair™)与广泛使用的单剂量 DPI(HandiHaler®)在中重度慢性阻塞性肺疾病患者中的偏好、满意度和关键错误。
在这项随机、开放标签、多中心、交叉研究中,患者(年龄≥40 岁)在加用当前药物的基础上,每天通过两种吸入器各吸入一次安慰剂,持续 2 周。主要终点是偏好 Genuair 超过 HandiHaler 的患者比例。评估总体患者满意度(5 分制:1=非常不满意;5=非常满意)、关键错误和继续使用每种吸入器的意愿(0=不愿意;100=肯定愿意)。
在 130 名随机患者中,105 名患者被纳入意向治疗人群(71.4%为男性;平均年龄 65.7 岁)。治疗 2 周后,更喜欢 Genuair 的患者明显多于更喜欢 HandiHaler 的患者(79.1%比 20.9%;p<0.0001)。Genuair 的总体满意度评分(4.6 比 3.8;p<0.0001)和继续使用意愿评分(84.0 比 62.5;p<0.0001)均显著高于 HandiHaler。与仅使用 HandiHaler 相比,仅使用 Genuair 的患者发生≥1 个关键错误的明显更少(2.9%比 19.0%;p<0.0001)。
经过 2 周的实践,患者更喜欢且更愿意继续使用 Genuair 而不是 HandiHaler。与 HandiHaler 相比,Genuair 与更高的患者满意度和更少的关键错误相关。