A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler using co-suspension delivery technology in patients with COPD

• DOI: 10.2147/copd.s171707
• Publication Date: 2018-08-29T23:11:30Z
• Authors: Wilfried De Backer; Jan De Backer; Wim Vos; Ilse Verlinden; Cedric Van Holsbeke; Johan Clukers; Bita Hajian; Shahid Siddiqui; Martin Jenkins; Colin Reisner; Ubaldo J Martin
• Keywords: Metered-dose inhaler; Crossover study; Dry-powder inhaler; Plethysmograph

A randomized study using functional respiratory imaging to characterize bronchodilator effects of glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler co-suspension delivery technology in patients with COPD Wilfried De Backer,1 Jan Backer,2 Wim Vos,3 Ilse Verlinden,3 Cedric Van Holsbeke,3 Johan Clukers,1 Bita Hajian,1 Shahid Siddiqui,4 Martin Jenkins,5 Colin Reisner,4,6 Ubaldo J Martin4 1Department Respiratory Medicine, University Antwerp, Belgium; 2FLUIDDA, Los Angeles, CA, USA; 3FLUIDDA, Kontich, 4AstraZeneca, Gaithersburg, MD, 5AstraZeneca, Cambridge, UK; 6Pearl – member the AstraZeneca Group, Morristown, NJ, USA Background: Functional (FRI) uses high-resolution computed tomography (HRCT) scans assess changes airway volume and resistance. Patients methods: In this randomized, double-blind, 2-week, crossover, Phase IIIB study, moderate-to-severe received twice-daily (GFF MDI, 18/9.6 µg) placebo formulated innovative technology. Co-primary endpoints included following: specific image-based (siVaw) resistance (siRaw) at Day 15, measured FRI. Secondary other change from baseline post-dose forced expiratory 1 second (FEV1) inspiratory capacity (IC; spirometry) ratio residual (FRC) (RV; body plethysmography). Results: Twenty (46–78 years age) were treated; whom 19 completed study. GFF MDI treatment increased siVaw 75% reduced siRaw 71% vs (both P