SESSION TITLE: COPD Posters V
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: QVA149 is a dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist, indacaterol (IND) and the long-acting muscarinic antagonist, glycopyrronium (GLY), approved in over 50 countries including the EU, Japan, Mexico, Canada and Australia for maintenance treatment of COPD. The FLIGHT1 and FLIGHT2 studies compared the efficacy and safety of QVA149 (IND/GLY) with its monocomponents and placebo. Here, we present the pooled data from FLIGHT1 and FLIGHT2 studies to evaluate the superiority of IND/GLY in terms of improvement in lung function and reduction in rescue medication usage over its monocomponents and placebo.
METHODS: FLIGHT1 and FLIGHT2 were replicate, multi-center, double-blind, parallel-group, placebo- and active-controlled studies. COPD patients with moderate-to-severe airflow limitation were randomized (1:1:1:1) to IND/GLY (27.5/12.5 μg), IND (27.5 μg), GLY (12.5 μg) or placebo (all twice daily). Data on improvement in lung function in terms of FEV1 AUC0-12h and reduction in rescue medication usage with IND/GLY versus its monocomponents (IND and GLY) and placebo were pooled and analyzed.
RESULTS: In total, data of 2038 patients (IND/GLY, n=508; IND, n=511; GLY, n=511; placebo, n=508) from both the studies were pooled and analyzed. On Day 1 and at Week 12, IND/GLY significantly (p<0.001) improved FEV1 AUC0-12h with a least squares mean (LSM) treatment difference of 95 mL and 103 mL versus IND, 45 mL and 88 mL versus GLY and 171 mL and 246 mL versus placebo, respectively. Patients treated with IND/GLY used significantly less rescue medication (puffs/day) compared with placebo (LSM treatment difference: -1.20; p<0.001), IND (LSM treatment difference: -0.33; p=0.011) and GLY (LSM treatment difference: -0.50; p<0.001).
CONCLUSIONS: The IND/GLY fixed-dose combination demonstrated significant improvemnt in lung function and reduction in rescue medication usage over its monocomponents and placebo in COPD patients with moderate-to-severe airflow limitation..
CLINICAL IMPLICATIONS: These findings support the potential of IND/GLY as an alternative treatment option for COPD patients with moderate-to-severe airflow limitation.
DISCLOSURE: Edward Kerwin: Consultant fee, speaker bureau, advisory committee, etc.: Served on advisory boards, speaker panels, or received travel reimbursement for Amphastar, Astra Zeneca, Forest, Ironwood, Merck, Mylan, Novartis, Pearl, Pfizer, Sanofi Aventis, Sunovion, Targacept, Teva and Theravance. , Grant monies (from industry related sources): Conducted multicenter clinical research trials for Novartis Tim Ayers: Employee: Employee of the study sponsor, Novartis and no other conflicts Samopriyo Maitra: Employee: Employee of the study sponsor, Novartis and no other conflicts Francesco Patalano: Employee: Employee of the study sponsor, Novartis and no other conflicts Donald Banerji: Employee: Employee of the study sponsor, Novartis and no other conflicts
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