a Global Med Affairs - Respiratory, Novartis Pharmaceuticals Corporation , East Hanover , NJ , USA.
b Respiratory Research, CEMER Centro Médico de Enfermedades Respiratorias , Buenos Aires , Argentina.
Curr Med Res Opin. 2019 Feb;35(2):221-227. doi: 10.1080/03007995.2018.1464437. Epub 2018 May 15.
The primary objective of the ADVANTAGE study was to compare device-naïve chronic obstructive pulmonary disease (COPD) patients' perception of the Breezhaler and Ellipta devices' feedback mechanisms of dose delivery confirmation. The secondary objective was to assess comfort with the inhalers' mouthpiece in terms of ease to form a tight seal around the mouthpiece. These objectives were achieved by using a novel, patient perception of inhaler questionnaire developed and tested during cognitive interviews of patients by Evidera, London, United Kingdom.
Ten COPD patients were interviewed to collect feedback on the interpretation, relevance and language of the questionnaire. This questionnaire was then used in ADVANTAGE to compare patients' perception (n = 100) of both devices. Patients completed the questionnaire after a single inhalation of placebo through each inhaler.
Using the final questionnaire, patients reported being more confident of the feedback mechanism of Breezhaler than that of the Ellipta device (mean score 4.3 versus 3.6 respectively, estimated difference [95% CI]: 0.75 [0.51, 0.99], p < .0001). Patients also reported better comfort (ease to form a tight seal with the lips) with the Breezhaler mouthpiece than the Ellipta mouthpiece (mean score 4.3 versus 3.9 respectively, estimated difference [95% CI]: 0.41 [0.21, 0.61], p < .0001). There were no safety concerns associated with either device.
COPD patients showed greater preference for the Breezhaler over the Ellipta inhaler for confidence of dose delivery and comfort of the mouthpiece.
The trial is registered at ClinicalTrials.gov (ClinicalTrials.gov number NCT02551224).
ADVANTAGE 研究的主要目的是比较初次使用装置的慢性阻塞性肺疾病（COPD）患者对 Breezhaler 和 Ellipta 装置剂量输送确认反馈机制的感知。次要目的是评估患者对吸入器吸嘴的舒适度，包括在吸嘴周围形成紧密密封的容易程度。这些目标是通过使用一种新型的、由英国伦敦 Evidera 公司在对患者进行认知访谈中开发和测试的、患者对吸入器感知的问卷来实现的。
对 10 名 COPD 患者进行了访谈，以收集对问卷的解释、相关性和语言的反馈。该问卷随后在 ADVANTAGE 中用于比较 100 名患者对两种装置的感知。患者在通过每种吸入器吸入安慰剂后，立即完成问卷。
使用最终的问卷，患者报告对 Breezhaler 的反馈机制比 Ellipta 装置更有信心（平均得分分别为 4.3 和 3.6，估计差值[95%CI]：0.75[0.51，0.99]，p<0.0001）。患者还报告说，Breezhaler 吸嘴的舒适度（用嘴唇形成紧密密封的容易程度）优于 Ellipta 吸嘴（平均得分分别为 4.3 和 3.9，估计差值[95%CI]：0.41[0.21，0.61]，p<0.0001）。两种装置均无安全性问题。
COPD 患者对 Breezhaler 吸入器的剂量输送信心和吸嘴舒适度表现出更大的偏好。
该试验在 ClinicalTrials.gov 注册（ClinicalTrials.gov 编号：NCT02551224）。
