Elkins Mark R, Anderson Sandra D, Perry Clare P, Daviskas Evangelia, Charlton Brett
Royal Prince Alfred Hospital, Sydney, Australia.
Pharmaxis Ltd, Sydney, Australia.
Open Respir Med J. 2014 Jan 24;8:8-13. doi: 10.2174/1874306401408010008. eCollection 2014.
Drug inhalation via a dry-powder inhaler (DPI) is a convenient, time efficient alternative to nebulizers in the treatment of cystic fibrosis (CF) or non-CF bronchiectasis. Efficient drug administration via DPIs depends on the device resistance and adequate (≥45L/min) inspiratory flows and volumes generated by individuals. Drypowder mannitol is delivered using a RS01 breath-actuated device developed by Plastiape, for Pharmaxis. The study aim was to determine in vivo if non-CF bronchiectasis patients' inspiratory flows and volumes are adequate to use the RS01 DPI device.
An open, non-interventional study; enrolled 17 subjects with non-CF bronchiectasis, 18 to 80 years, with baseline FEV1 ≥1.0L and ≥50‰ predicted. Inspiratory flows and volumes were measured when subjects inhaled in a controlled manner through the RS01 device in series with a spirometer.
The mean inspiratory volume (IV) of non-CF bronchiectasis subjects was 2.08 ± 0.5L and achieved a mean PIF of 78.6 ± 11.2L/min with the inhaler device.
Use of the RS01 DPI device allowed adequate inspiratory flow and volume for dispersion of dry-powder mannitol in non-CF bronchiectasis patients.
通过干粉吸入器（DPI）吸入药物是治疗囊性纤维化（CF）或非CF支气管扩张症时，一种比雾化器更方便、更省时的替代方法。通过DPI有效给药取决于设备阻力以及个体产生的足够（≥45L/分钟）吸气流量和容量。干粉甘露醇使用由Plastiape为Pharmaxis开发的RS01呼吸驱动装置给药。本研究的目的是在体内确定非CF支气管扩张症患者的吸气流量和容量是否足以使用RS01 DPI装置。
一项开放性、非干预性研究；纳入17名年龄在18至80岁之间、基线第一秒用力呼气容积（FEV1）≥1.0L且预测值≥50‰的非CF支气管扩张症患者。当受试者通过与肺活量计串联的RS01装置以受控方式吸气时，测量其吸气流量和容量。
非CF支气管扩张症患者的平均吸气容积（IV）为2.08±0.5L，使用吸入器装置时平均峰值吸气流量（PIF）达到78.6±11.2L/分钟。
使用RS01 DPI装置可为非CF支气管扩张症患者提供足够的吸气流量和容量，以分散干粉甘露醇。
