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

International Journal of Chronic Obstructive Pulmonary Disease
Wilfried De BackerUbaldo J Martin

Abstract

Functional respiratory imaging (FRI) uses high-resolution computed tomography (HRCT) scans to assess changes in airway volume and resistance. 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 μg) 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 (FEV1) and inspiratory capacity (IC; spirometry) and ratio to baseline in post-dose functional residual capacity (FRC) and residual volume (RV; body plethysmography). 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<0.0001). Image-based airway volume (iVaw) and image-based airway resistance (iRaw), without adjusting for lobe volume, demonstrated corresponding findings...Continue Reading

Citations

Aug 31, 2019·Drugs·Zaina T Al-Salama, James E Frampton
Apr 2, 2020·Respiratory Research·David LangtonFrancis Thien
Aug 11, 2020·Expert Review of Respiratory Medicine·Pierre-Edouard GrilletArnaud Bourdin
Jul 4, 2020·The European Respiratory Journal·Justin L Garner, Pallav L Shah
Aug 7, 2020·American Journal of Respiratory and Critical Care Medicine·Sandeep BodduluriSurya P Bhatt
Jan 28, 2021·International Journal of Chronic Obstructive Pulmonary Disease·Omar S UsmaniWilfried De Backer

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NCT02643082

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