SESSION TITLE: COPD Posters III
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: QVA149 is 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, Canada, Mexico, Australia and Switzerland, for the maintenance treatment of chronic obstructive pulmonary disease (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 analysis data on lung function, dyspnea and health-status in the subgroup of patients from the USA that were treated with IND/GLY and placebo, from the FLIGHT1 and FLIGHT2 studies.
METHODS: FLIGHT1 and FLIGHT2 were replicate, multicenter, randomized, double-blind, parallel-group, placebo- and active-controlled studies. Data on improvement in lung function (FEV1 AUC0-12h, trough FEV1), dyspnea (transition dyspnea index, TDI), health status (St George's Respiratory Questionnaire, SGRQ) and rescue medication use with IND/GLY versus placebo were pooled and analyzed.
RESULTS: A total of 554 patients from the USA sites were included in this analysis (IND/GLY, n=275; placebo, n=279). IND/GLY demonstrated statistically significant and clinically meaningful improvements versus placebo in both FEV1 AUC0-12h (least squares mean treatment difference [LSMTD], 267 mL; p<0.001) and trough FEV1 (LSMTD, 239 mL; p<0.001) at Week 12. Patients treated with IND/GLY showed clinically meaningful and statistically significant improvement in TDI total score (LSMTD 1.55; p<0.001) and SGRQ total score (LSMTD -4.2; p<0.001) compared with placebo at Week 12. The proportion of responders at Week 12 with IND/GLY versus placebo in TDI total score (odds ratio 2.34; p<0.001) and SGRQ total score (odds ratio 2.22; p<0.001) was also statistically significant. Change from baseline in rescue medication use over 12 weeks was significantly lower in IND/GLY treated patients versus placebo treated patients (LSMTD -1.44; p<0.001).
CONCLUSIONS: In this pooled analysis, IND/GLY demonstrated statistically significant and clinically meaningful improvements in lung function, dyspnea, health status and rescue medication use compared to placebo in the USA subgroup of patients from these studies.
CLINICAL IMPLICATIONS: IND/GLY may be considered as a therapeutic option to improve dyspnea and quality of life while reducing rescue medication use in patients with moderate-to-severe COPD.
DISCLOSURE: Angel FowlerTaylor: Employee: Employee of the study sponsor Novartis and no other conflicts Samopriyo Maitra: Employee: Employee of the study sponsor Novartis and no other conflicts Robert Fogel: 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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