Abstract
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 FEV1 and computerised TDI focal score over 24 weeks.
Results: For trough FEV1, PT003, PT001, and PT005 were superior to placebo and PT003 was superior to PT001 and PT005 (p<0.0001) (table). For TDI focal score, variable results were obtained for PT001 and PT005 vs placebo. PT003 provided benefit vs placebo (p≤0.0041) and PT001 (p≤0.0199) in both studies, and vs PT005 in PINNACLE-2 (p=0.0028) with a smaller benefit in PINNACLE-1 (p=0.1060). There were no unexpected safety findings.
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.
- Copyright ©ERS 2015
