LATE-BREAKING ABSTRACT: PT003, a novel co-suspension MDI glycopyrronium/formoterol fixed-dose combination is superior to monocomponents in patients with COPD

Background: PT003 is a novel co-suspension MDI combination of two long-acting bronchodilators, the LAMA glycopyrronium (GP 14.4µg) and the LABA formoterol fumarate (FF 9.6µg). We investigated the efficacy and safety of PT003 vs individual components PT001 (GP MDI 14.4µg) and PT005 (FF MDI 9.6µg) in patients with moderate to very severe COPD in two Phase 3 studies (PINNACLE-1 and -2). Methods: In these two randomised, double-blind, placebo-controlled, parallel-group, multicentre studies patients received PT003, PT001, PT005 or placebo, all delivered via co-suspension technology MDI (7:6:6:3) twice-daily for 24 weeks; PINNACLE-1 included open-label tiotropium 18μg once-daily. Primary endpoints were change from baseline in morning trough FEV 1 and computerised TDI focal score over 24 weeks. Results: For trough FEV 1 , PT003, PT001, and PT005 were superior to placebo and PT003 was superior to PT001 and PT005 (p Conclusion: The results from PINNACLE-1 and -2 support the overall efficacy of PT003 (GP 14.4µg/FF 9.6µg MDI) as a bronchodilator therapy for patients with COPD.