Abstract
Objective: To assess the relationship of baseline eosinophil (EOS) levels with treatment responses to BGF MDI 320/14.4/10 µg (ICS/LAMA/LABA), glycopyrronium/formoterol [GFF] MDI 14.4/10 µg (LAMA/LABA) and budesonide/formoterol [BFF] MDI 320/10 µg (ICS/LABA). Methods: Pre-specified analysis of lung function and exacerbation endpoints in a Phase III, double-blind, parallel-group, 24-week study (NCT02497001) by baseline blood EOS count ( Results: Most subjects (87.8%) were in GOLD group B. Overall improvements in change from baseline in morning pre-dose trough FEV1 and FEV1 AUC0−4 over 24 weeks for BGF MDI vs GFF MDI were driven by the ≥150 cells/mm3 subgroup (Table). However, BGF MDI reduced exacerbation rate vs GFF MDI in both EOS subgroups; in the continuous analyses, treatment differences for BGF MDI vs GFF MDI for exacerbations increased with improvements of ~15% or more beginning at blood EOS levels of 50–100 cells/mm3. Improvements with BGF MDI vs BFF MDI were generally independent of baseline EOS counts. Conclusion: Lung function benefits for BGF MDI vs GFF MDI were greater in subjects with higher baseline EOS levels. Exacerbation benefits were evident in both EOS subgroups but higher with increasing EOS levels.
Published Version
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