SESSION TITLE: COPD Posters IV
SESSION TYPE: Original Investigation Poster
PRESENTED ON: Wednesday, October 28, 2015 at 01:30 PM - 02:30 PM
PURPOSE: The SGRQ is a well-recognized tool for evaluation of quality of life in patients with COPD. The questionnaire consists of three components, symptoms, activity and impact. QVA149 110/50 µg, once daily, is a fixed-dose combination of long-acting β2-agonist, indacaterol (IND) and long-acting muscarinic antagonist, glycopyrronium (GLY), approved in over 50 countries including EU, Japan, Canada, Mexico, Australia and Switzerland for maintenance treatment of patients with COPD. The FLIGHT1 and FLIGHT2 studies evaluated the improvement in SGRQ total score with twice daily QVA149 (IND/GLY 27.5/12.5 µg), versus its monocomponents and placebo. Here, we report the results of pooled analysis in terms of improvement in the SGRQ component scores with IND/GLY compared with IND, GLY and placebo.
METHODS: The FLIGHT1 and FLIGHT2 studies were multi-center, double-blind, placebo- and active-controlled, parallel-group studies that randomized patients with moderate to severe COPD to IND/GLY 27.5/12.5 µg, IND 27.5 µg, GLY 12.5 µg or placebo (all twice daily) to assess the efficacy and safety of IND/GLY versus its monocomponents and placebo.
RESULTS: Overall, 2038 patients were included in the pooled analysis (IND/GLY, n=508; IND, n=511; GLY, n=511; placebo, n=508). IND/GLY showed statistically significant improvement in SGRQ total score change from baseline versus IND (least squares mean treatment difference [LSMTD]: -1.7), GLY (LSMTD: -1.5) and placebo (LSMTD: -5.0) at Week 12. Compared with placebo, IND/GLY demonstrated a statistically significant (p<0.001) improvement in all SGRQ component scores. Additionally, improvement in symptom component score was statistically significant (p<0.001) with IND/GLY versus IND and GLY (LSMTD: -3.5 and -3.7, respectively). IND/GLY showed statistically significant improvement in impact component score versus GLY (LSMTD: -1.7, p<0.05). Improvement in activity component score was comparable between IND/GLY and its monocomponents.
CONCLUSIONS: In patients with moderate to severe COPD, IND/GLY showed statistically significant improvements in all the SGRQ component scores compared with placebo.
CLINICAL IMPLICATIONS: IND/GLY can be considered as an alternative treatment which can improve the health status of the patients with moderate to severe COPD.
DISCLOSURE: Paul Jones: Consultant fee, speaker bureau, advisory committee, etc.: Received lecture and consultant fees from Novartis 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 Angel FowlerTaylor: 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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