Beneficial effect of the LAMA/LABA glycopyrronium (GP)/formoterol (FF) fixed-dose combination, delivered using a novel MDI co-suspension technology (GFF MDI), in COPD GOLD group A and B patients

Background GOLD recommends the use of a LAMA or LABA in patients categorised as group A or B. In this post-hoc analysis, we sought to evaluate the effect of the LAMA/LABA GFF MDI, compared with its monocomponents and placebo (PBO) in COPD patients categorized as GOLD A or B. Methods Pooled analysis of two randomised, double-blind, PBO-controlled studies (PINNACLE-1 [NCT01854645] and -2 [NCT01854658]), in which patients received GFF MDI (14.4/9.6µg), GP MDI (14.4µg), FF MDI (9.6µg) or PBO MDI (all twice daily), or open-label tiotropium 18µg (once daily; PINNACLE-1 only), evaluated lung function over 24 weeks. Results ITT population included GOLD group A (n=227) and B patients (n=1360). Overall, GFF MDI increased the change from baseline in morning pre-dose trough FEV1 and peak change in FEV1 within 2h post-dose vs FF MDI, GP MDI and PBO in both GOLD A and GOLD B groups (Table). The effect of GFF MDI vs comparators was at least as large in GOLD group A patients as in GOLD group B. Conclusion In a post-hoc analysis, GFF MDI improved lung function vs GP MDI, FF MDI and PBO MDI in COPD patients categorised as GOLD A or B. Further evaluation of LAMA/LABAs in this patient population is warranted.