Late Breaking Abstract - Functional respiratory imaging (FRI) and lung function assessment of glycopyrronium/formoterol fumarate dihydrate fixed-dose combination delivered using novel Co-Suspension Delivery Technology (GFF MDI) in COPD

Abstract

Introduction: FRI has been used to provide a detailed view of overall and local changes in airway resistance and lung volume, in addition to spirometry and body plethysmography. Aims and objectives: To assess changes in specific image-based airway volume (siVaw) and resistance (siRaw) in patients with moderate-to-severe COPD after administration of GFF vs placebo. Methods: In this double-blind, 2-week dosing, Phase III crossover study (NCT02643082), 20 patients (40–80 years) received twice daily GFF MDI 14.4/10µg (equivalent to glycopyrrolate/formoterol fumarate 18/9.6μg) and placebo MDI. Primary endpoints were siVaw and siRaw at Day 15. Additional outcomes included spirometry, plethysmography and safety. Results: On Day 15, GFF MDI led to an estimated 75% increase in siVaw and 71% decrease in siRaw relative to placebo MDI (both p 1 and 454mL in IC in change from baseline for GFF MDI vs placebo MDI (both p Conclusion: The dual bronchodilator GFF MDI demonstrated significant benefits on FRI‑based airway volume and resistance in the lungs of COPD patients. Benefits were associated with important improvements in FEV 1 , IC and hyperinflation.