1 Clinical Research Institute of Southern Oregon, PC, Medford, Oregon.
2 University of North Carolina School of Medicine, Chapel Hill, North Carolina.
J Aerosol Med Pulm Drug Deliv. 2019 Feb;32(1):24-33. doi: 10.1089/jamp.2018.1477. Epub 2018 Nov 17.
Effective delivery of inhaled drugs in chronic obstructive pulmonary disease (COPD) depends on patients' ability to correctly use an inhalation device. Nebulized delivery may be appropriate for COPD patients who cannot coordinate breath with inhalation or generate adequate inhalational force. Until recently, long-acting muscarinic antagonists (LAMAs), used for maintenance treatment of COPD, were available for delivery only via handheld inhalers. Lonhala™ Magnair™ (glycopyrrolate inhalation solution) is a LAMA delivered via the eFlow closed-system (eFlow CS) vibrating membrane nebulizer. We assessed patient-reported ease of use and satisfaction with the eFlow CS nebulizer in the GOLDEN (Glycopyrrolate for Obstructive Lung Disease via Electronic Nebulizer)-5 study.
GOLDEN-5, a phase 3, randomized, open-label trial, evaluated the safety and efficacy of glycopyrrolate/eFlow CS 50 μg twice daily versus tiotropium 18 μg once daily (administered via HandiHaler™) in patients with moderate-to-very severe COPD. Only patients in the glycopyrrolate/eFlow CS group completed a study-specific device use questionnaire, evaluating patients' perceptions about ease of use, confidence in drug delivery, and overall device satisfaction at week 48 or end of study. Responses were summarized by counts and percentages.
Of 620 patients who received glycopyrrolate/eFlow CS, 454 completed the questionnaire (mean age [standard deviation, SD] 63.3 [8.5] years; mean BMI [SD] 28.45 [6.208] kg/m). Based on patient-reported perceptions, most patients (83%) were "confident" to "very confident" that the drug was delivered into their lungs with the eFlow CS; >70% rated the eFlow CS as "easy" or "very easy" to assemble, operate, and clean. Most (75%) patients ranked themselves as being "satisfied" or "very satisfied" overall with the eFlow CS nebulizer.
High levels of satisfaction, confidence, and ease of use were reported with the eFlow CS nebulizer in this study. These findings support the use of the eFlow CS for maintenance treatment of COPD with glycopyrrolate inhalation solution.
吸入药物在慢性阻塞性肺疾病（COPD）中的有效输送取决于患者正确使用吸入装置的能力。对于无法与吸入协调呼吸或产生足够吸入力的 COPD 患者，雾化输送可能是合适的。直到最近，长效毒蕈碱拮抗剂（LAMA），用于 COPD 的维持治疗，仅可通过手持吸入器提供。Lonhala™ Magnair™（格隆溴铵吸入溶液）是通过 eFlow 密闭系统（eFlow CS）振动膜雾化器输送的 LAMA。我们在 GOLDEN（通过电子雾化器给予格隆溴铵治疗阻塞性肺病）-5 研究中评估了患者对 eFlow CS 雾化器易用性和满意度的报告。
GOLDEN-5 是一项 3 期、随机、开放标签试验，评估了格隆溴铵/eFlow CS 50μg，每日 2 次与噻托溴铵 18μg，每日 1 次（通过 HandiHaler™给予）在中重度至重度 COPD 患者中的安全性和疗效。只有格隆溴铵/eFlow CS 组的患者完成了一项特定于研究的设备使用问卷，评估了患者在第 48 周或研究结束时对易用性、药物输送信心和整体设备满意度的看法。结果以计数和百分比进行总结。
在接受格隆溴铵/eFlow CS 的 620 名患者中，454 名完成了问卷（平均年龄[标准差，SD]63.3[8.5]岁；平均 BMI[SD]28.45[6.208]kg/m）。根据患者报告的认知，大多数患者（83%）对 eFlow CS 将药物输送到肺部有“信心”至“非常有信心”；超过 70%的患者认为 eFlow CS 易于组装、操作和清洁。大多数（75%）患者对 eFlow CS 整体满意度评为“满意”或“非常满意”。
这项研究报告了 eFlow CS 雾化器的高满意度、信心和易用性。这些发现支持使用 eFlow CS 对格隆溴铵吸入溶液维持治疗 COPD。
