Abstract
Background: FF/UMEC/VI is a novel ICS/LAMA/LABA therapy. Dual therapies of FF/VI and UMEC/VI were recently approved for treatment of moderate-severe COPD.
Objective: Comparison of systemic exposure after co-administration of FF, UMEC and VI in a single inhaler compared with the dual therapies FF/VI, UMEC/VI and FF/UMEC (all in ELLIPTA™ dry powder inhaler).
Methods: In a double-blind, single-dose, 4-way crossover study, healthy subjects (N=44) were randomised to 4 treatment sequences, each comprising 4 treatments (table) in different order. Systemic exposure of FF, UMEC and VI was assessed by PK sampling up to 48h post-dose. Systemic pharmacodynamics (PD) and safety were also assessed.
Results: Estimates of total systemic exposure (AUC(0–t')) for FF, UMEC and VI were similar between FF/UMEC/VI and dual combinations (table). Differences in Cmax values for FF and VI across treatments were seen that are not considered clinically relevant. There were no PD or safety findings of clinical concern.
Conclusions: FF/UMEC/VI delivered in a single inhaler achieved similar exposure to that seen with the dual therapies investigated. The safety and delivered lung dose of all three agents in a single inhaler are expected to be similar to corresponding dual therapies.
Funding: GSK (CTT116415;NCT01691547)
- © 2014 ERS