Benefits of the LAMA/LABA glycopyrronium (GP)/formoterol (FF) MDI FDC, delivered using a novel MDI co-suspension technology (GFF MDI), increase with baseline symptom severity in COPD patients (pts)

Objective To assess whether baseline severity of COPD symptoms affects treatment response in COPD pts receiving GFF MDI. Methods Pooled data from two Phase III, 24-week, multicentre, randomised, double-blind, parallel-group and placebo (PBO)-controlled trials (PINNACLE-1 [NCT01854645] u0026 -2 [NCT01854658]) were stratified by baseline CAT score in a post-hoc analysis. Efficacy outcomes were analysed in pts receiving GFF MDI 14.4/9.6µg, GP MDI 14.4µg, FF MDI 9.6µg, or PBO (all twice daily), or open-label tiotropium 18µg (once daily, PINNACLE-1 only). Changes in FEV 1 , exacerbation rates and HRQoL were assessed over 24 weeks. Results Baseline CAT scores were Conclusion The benefits of GFF MDI on symptomatic endpoints increase with increasing severity of baseline COPD symptoms, supporting further assessment of the symptomatic benefits of GFF MDI in COPD pts with a high baseline symptom burden.