LATE-BREAKING ABSTRACT: Pulmonary deposition of a novel LAMA/LABA Co-Suspension™ technology glycopyrronium/formoterol (GFF) MDI in healthy subjects (PT003020)

Background GFF MDI showed efficacy in Phase III trials of patients with moderate-to-very-severe COPD. Lung deposition and the regions where it occurs may relate to specific receptor activation and aerosol performance. We evaluated pulmonary deposition of radiolabelled GFF delivered by Co-Suspension ™ Technology MDI (porous particles). Methods In this Phase I, randomized, single-blind, single-dose, single-centre, placebo-controlled study, healthy male subjects (n=10) received two inhalations of 99m Tc-pertechnetate (≤10MBq) radiolabelled GFF 14.4/9.6μg or placebo (porous particles only) in a crossover design with a ≥5-day washout. In vitro analyses showed that aerosol delivery was unaltered by radiolabel application. Gamma counts of the lungs, stomach, oropharynx, mouthwash and exhalation filter were determined. Results Radioactivity detected in the various regions (Table 1) showed deposition in both central and peripheral regions, with very low exhaled fraction. Deposition was similar between GFF MDI and placebo MDI. One treatment-related adverse event occurred with GFF MDI and one with placebo MDI; neither were serious. Conclusion Both GFF and placebo MDI Co-Suspension™ formulations were efficiently deposited in the lungs with similar regional deposition patterns. The variability observed among subjects was typical of inhalation studies.