In-vitro product performance of fluticasone furoate (FF)/umeclidinium (UMEC)/vilanterol (VI) delivered from a dry powder inhaler (DPI) using the Electronic Lung (EL) to replicate patient inhalation profiles

Abstract

Introduction: When using a DPI, critical patient inhalation characteristics such as inspiratory flow rate and inhaled volume vary widely between individuals, disease state and severity. Aim: This study aimed to evaluate the dose delivery performance of a triple combination DPI (Trelegy ELLIPTA) containing FF/UMEC/VI 100/62.5/25 μg, across the full range of inhalation characteristics relevant to patients with all severities of chronic obstructive pulmonary disease (COPD). Method: Five representative pre-recorded patient inhalation profiles encompassing the full range of peak inspiratory flow rates (PIFRs) for patients of all COPD severities (Prime D, et al. J Aerosol Med Pulm Drug Deliv, 2015), were replicated using the EL breathing simulator with a coated anatomical throat model and Next Generation Impactor (Hamilton M, et al. J Aerosol Med Pulm Drug Deliv, 2015). Dose deposited within the throat and impactor stages were analysed to determine the delivered dose (DD) and fine particle dose (FPD, mass Results: Mean DD and FPD were consistent for FF, UMEC and VI (Figure) across the full range of patient-relevant inhalation characteristics, including PIFR 43.5 to 129.9L/min. Conclusion: COPD patients, including those with very severe COPD, can achieve the inspiratory effort required for consistent dose delivery.