SESSION TITLE: Emerging Therapies in COPD
SESSION TYPE: Original Investigation Slide
PRESENTED ON: Tuesday, October 27, 2015 at 02:45 PM - 04:15 PM
PURPOSE: FLIGHT1 and FLIGHT2 studies evaluated the efficacy and safety of a fixed-dose combination of indacaterol (IND) and glycopyrronium (GLY), QVA149 (IND/GLY 27.5/12.5 μg) in patients with moderate-to-severe COPD. Fixed-dose combination of IND/GLY 110/50 µg, once daily, is approved in over 50 countries including the EU, Japan, Canada, Mexico, Australia and Switzerland for maintenance treatment of COPD. Here, we present the pooled data on improvement in lung function parameters with IND/GLY, assessed as secondary endpoints during the studies.
METHODS: FLIGHT1 and FLIGHT2 were replicate, multi-center, randomized, double-blind, parallel-group, placebo- and active-control studies that randomized (1:1:1:1) patients with moderate-to-severe COPD to twice-daily (b.i.d) IND/GLY 27.5/12.5 µg, IND 27.5 µg, GLY 12.5 µg or placebo. Improvements in pre-dose trough FEV1, trough FEV1 and peak FEV1 during first 4 hours, were pooled and analyzed.
RESULTS: A total of 2038 patients were included in this overall pooled analysis (IND/GLY, n=508; IND, n=511; GLY, n=511; PBO, n=508). Pre-dose trough FEV1 change from baseline with IND/GLY was significantly improved (p<0.001) at Day 85 compared with monocomponents (LSM treatment difference 85 mL versus IND and 92 mL versus GLY) and versus placebo (LSM treatment difference 207 mL; p<0.001). Statistically significant improvements in trough FEV1 at Day 86 were demonstrated by IND/GLY versus monocomponents (LSM treatment difference 79 mL versus IND and 98 mL versus GLY; both p<0.001) and versus placebo (LSM treatment difference 223 mL; p<0.001). Similarly, significant improvements were observed with IND/GLY compared with monocomponents and placebo in terms of peak FEV1 during the first 4 hours (LSM treatment differences 99 mL, 34 mL and 167 mL on Day 1 and 124 mL, 93 mL and 275 mL at Week 12 versus IND, GLY and placebo, respectively; all p<0.001).
CONCLUSIONS: Pooled analysis of lung function outcomes from FLIGHT1 and FLIGHT2 studies demonstrated significant improvements with IND/GLY compared with its monocomponents and placebo in patients with moderate-to-severe COPD.
CLINICAL IMPLICATIONS: IND/GLY could be considered an effective therapeutic option for maintenance treatment of patients with moderate-to-severe COPD.
DISCLOSURE: Edward Kerwin: Consultant fee, speaker bureau, advisory committee, etc.: Served on advisory boards, speaker panels, or recived travel reimbursement from Novartis, Grant monies (from industry related sources): Received research grant on Industry related sources Tim Ayers: Employee: Employee of Novartis Angel FowlerTaylor: Employee: Employee Of Novartis Francesco Patalano: Employee: Employee of Novartis Donald Banerji: Employee: Employee of Novartis Samopriyo Maitra: Employee: Employee of Novartis
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