SESSION TITLE: COPD Posters V
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: The St. George's Respiratory Questionnaire (SGRQ) is an extensively used self-administered questionnaire that measures and quantifies health-related quality of life in patients with COPD. QVA149 (IND/GLY, a fixed-dose combination of indacaterol 110 μg [IND, a long-acting β2-agonist] and glycopyrronium 50 μg [GLY, a long-acting muscarinic antagonist]) is approved in over 50 countries including the EU, Japan, Canada, Mexico, Australia and Switzerland, for the maintenance treatment of COPD. The FLIGHT1 and FLIGHT2 studies evaluated the improvement in health status with twice-daily IND/GLY 27.5/12.5 μg compared with placebo and its monocomponents, as a key secondary objective in patients with moderate-to-severe COPD. We present the health status improvement with IND/GLY as measured by reduction in SGRQ total score, from the pooled data of the FLIGHT1 and FLIGHT2 studies.
METHODS: FLIGHT1 and FLIGHT2 were replicate, 12-week, multicenter, double-blind studies, which randomized patients with moderate-to-severe COPD (1:1:1:1) to IND/GLY 27.5/12.5 μg, IND 27.5 μg, GLY 12.5 μg or placebo (all delivered twice daily). Data from these studies were pooled to demonstrate the superiority of IND/GLY versus placebo for change in health status, and to access the percentage of patients achieving minimal clinically important difference (MCID ≥4 units) in SGRQ score at Week 12.
RESULTS: A total of 1891 patient’s data from the FLIGHT1 and FLIGHT2 studies were pooled and analyzed (IND/GLY, n=484; IND, n=478; GLY, n=480 and placebo, n=449). At Week 12, improvement in SGRQ total score exceeded the MCID with IND/GLY versus placebo (least squares mean treatment difference [LSMTD]: -5.0, p<0.001), while statistically significant improvements in SGRQ total score were observed versus IND (LSMTD: -1.7; p<0.05) and GLY (LSMTD: -1.5; p<0.05). The proportion of patients achieving the MCID of -4 units was significantly higher with IND/GLY (58.3%) compared with placebo (36.7%, odds ratio [OR] 2.50, p<0.001) and its monocomponents (IND [52.3%, OR 1.32, p<0.05] and GLY [48.8%, OR 1.50, p<0.01]).
CONCLUSIONS: In patients with moderate-to-severe COPD, IND/GLY demonstrated statistically significant improvement in health status compared with placebo and its monocomponents.
CLINICAL IMPLICATIONS: IND/GLY could be considered as an alternate therapeutic option for treatment of patients with moderate-to-severe COPD.
DISCLOSURE: Paul Jones: Consultant fee, speaker bureau, advisory committee, etc.: Received lecture and consultant fees from Novartis Angel FowlerTaylor: Employee: Employee of the study sponsor, Novartis and no other conflicts Michael Larbig: Employee: Employee of the study sponsor, Novartis and no other conflicts Samopriyo Maitra: 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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