P192 Functional respiratory imaging (fri) and lung function assessment of glycopyrronium/formoterol fumarate dihydrate fixed-dose combination delivered using innovative co-suspension delivery technology (gff mdi) in copd. (15th November 2017)

• Record Type: Journal Article
• Authors: De Backer, W; De Backer, J; Vos, W; Verlinden, I; Dwivedi, S; Siddiqui, S; Jenkins, M; Reisner, C; Martin, U
• Is Part Of: Thorax. Volume 72(2017)Supplement 3
• Page Start: A186
• Page End: A188
• Publication Date: 2017-11-15
• Subjects: Chest -- Diseases -- Periodicals; Thorax; Chest -- Diseases; Periodicals; Periodicals; 617.54
• DOI: 10.1136/thoraxjnl-2017-210983.334
• Languages: English
• ISSNs: 0040-6376

Abstract

Abstract : Introduction and Objectives: 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. The aim of this study was 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 14.4/10 µg (equivalent to glycopyrrolate/formoterol fumarate 18/9.6 µg) 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<0.0001; Table ), accompanied by post–dose differences of 443 mL in FEV1 and 454 mL in IC in change from baseline for GFF MDI vs placebo MDI (both p<0.001). The safety profile was consistent with the drug class with no unexpected safety findings. Conclusions: 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 FEV1, IC and hyperinflation.