Effect of Human Error, Inhalation Flow, and Inhalation Volume on Dose Delivery from Ellipta (R) Dry-Powder Inhaler

Abstract

Purpose Ellipta® is a new dry-powder inhaler (DPI), with mediumflow resistance. The present study aimed to evaluate Ellipta® dose preparation and inhalation technique and determine the effect of human factor, inhalation flow, and inhalation volume on total emitted dose (TED). Methods Two-hundred obstructive lung disease patients were asked to load Ellipta® dose and inhale from placebo Ellipta®, without receiving counseling (first attempt). They were divided into patients who previously used DPI (100 patients) and others who never used DPI before (100 patients). Secondly, TED of single-loaded dose from Relvar-Ellipta® was determined at different inhalation flows (20, 40, and 60 L/min) and inhalation volumes (2 and 4 L). TED was also determined after loading the dose twice at inhalation flows of 40 and 60 L/min and inhalation Q1 volume of 4 L. Doses were prepared while Ellipta® is in upright and horizontal positions. Results The number of handling errors performed by patients who previously used DPI was lower compared to others who never used DPI before. No significant difference was found between TEDs of 40 and 60 L/min inhalation flow at 2 or 4 L inhalation volume when loading Ellipta®, once or twice, in an upright or horizontal position. TED at inhalation flow of 20 L/min was significantly lower than at 40 and 60 L/min (p < 0.001). A 4-L inhalation volume significantly increased TED than 2 L/min only at inhalation flow of 20 L/min (p = 0.001). Conclusions Ellipta® is a consistent DPI. It can be used to deliver inhaled medication at a flow of ≥ 40 L/min without fear of not receiving the needed dose. It does not allow delivering double dosing.