Pooled analysis of 24-h lung function following treatment with the LAMA/LABA glycopyrronium/formoterol fumarate fixed-dose combination, delivered by a novel MDI co-suspension technology (GFF MDI), in COPD patients (pts)

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Background In Phase III studies, GFF MDI has shown efficacy in pts with moderate-to-very-severe COPD. We now present a post-hoc analysis of 24-h lung function data pooled from two subsequent Phase IIIb studies (PT003011 [NCT02347072]/PT003012 [NCT02347085]). Methods In these two randomised, double-blind, placebo-controlled, crossover studies, pts received GFF MDI 14.4/9.6μg or placebo MDI twice daily, or, in PT003011 only, open-label tiotropium (TIO; Spiriva® Respimat®) 5µg once daily with 7- to 21-day washouts. Lung function testing was performed over 24h on Day 29. Results The pooled population comprised 110 pts. GFF MDI significantly increased lung function vs placebo at all timepoints (all p<0.0001; Table). Further, pts who received GFF MDI had significantly greater improvements in peak FEV1 on Day 29 vs those who received TIO; the difference between GFF MDI and TIO was greater during the second, vs the first, 12h of dosing. Reliever use was significantly lower with GFF MDI vs either of the control groups. Conclusion Morning and evening dosing of GFF MDI led to consistent and sustained lung function improvements in pts with moderate-to-very-severe COPD. Improvements vs TIO were greater in the second, vs the first, 12h of dosing. These results support twice-daily dosing of GFF MDI.