부산대학교 도서관

Background: Functional respiratory imaging (FRI) uses high-resolution computed tomography (HRCT) scans to assess changes in airway volume and resistance. Patients and methods: In this randomized, double-blind, 2-week, crossover, Phase IIIB study, patients with moderate-to-severe COPD received twice-daily glycopyrrolate/formoterol fumarate delivered by a metered dose inhaler (GFF MDI, 18/9.6 [micro]g) and placebo MDI, formulated using innovative co-suspension delivery technology. Co-primary endpoints included the following: specific image-based airway volume (siVaw) and specific image-based airway resistance (siRaw) at Day 15, measured using FRI. Secondary and other endpoints included the following: change from baseline in post-dose forced expiratory volume in 1 second ([FEV.sub.1]) and inspiratory capacity (IC; spirometry) and ratio to baseline in post-dose functional residual capacity (FRC) and residual volume (RV; body plethysmography). Results: Twenty patients (46-78 years of age) were randomized and treated; of whom 19 completed the study. GFF MDI treatment increased siVaw by 75% and reduced siRaw by 71% vs placebo MDI (both P Conclusion: GFF MDI demonstrated significant, clinically meaningful benefits on FRI-based airway volume and resistance in patients with moderate-to-severe COPD. Benefits were associated with improvements in [FEV.sub.1], IC, and hyperinflation. Clinical trial registration: ClinicalTrials.gov: NCT02643082. Keywords: GFF MDI, airway volume, airway resistance, inspiratory capacity, hyperinflation, LAMA/LABA
Introduction Functional respiratory imaging (FRI), a post-processing technology, utilizes multislice high-resolution computed tomography (HRCT) scans and computational fluid dynamics to quantify anatomic and functional information in the respiratory system. (1) [...]