PT  - JOURNAL ARTICLE
AU  - Eric Bateman
AU  - Gary T. Ferguson
AU  - Neil Barnes
AU  - Nicola Gallagher
AU  - Yulia Green
AU  - Rachael Horton
AU  - Michelle Henley
AU  - Donald Banerji
TI  - Benefits of dual bronchodilation with QVA149 once daily versus placebo, indacaterol, NVA237 and tiotropium in patients with COPD: The SHINE study
DP  - 2012 Sep 01
TA  - European Respiratory Journal
PG  - 2810
VI  - 40
IP  - Suppl 56
4099  - http://erj.ersjournals.com/content/40/Suppl_56/2810.short
4100  - http://erj.ersjournals.com/content/40/Suppl_56/2810.full
SO  - Eur Respir J2012 Sep 01; 40
AB  - BackgroundQVA149 is a novel once-daily dual bronchodilator combining the LABA indacaterol and the LAMA NVA237 (glycopyrronium) in development for COPD.MethodsIn a double-blind study, 2144 patients with moderate-to-severe COPD were randomized (2:2:2:2:1) to receive QVA149 110/50µg, indacaterol (IND) 150µg, NVA237 50µg (NVA), open-label tiotropium (TIO) 18µg or placebo (PBO), for 26 weeks. The primary endpoint was trough FEV1 with QVA149 vs IND and NVA at 26 weeks.Results 89% patients completed the study. Trough FEV1 at Week 26 was significantly greater with QVA149 vs PBO, IND, NVA and TIO (mean difference: 200, 70, 90 and 80mL, respectively; p<0.001). Significant improvement was also seen with QVA149 in other outcome measures evaluating lung function, dyspnea, health status and rescue medication use (table).View this table:The incidence of adverse events was similar between groups (55% QVA149; 61% IND and NVA; 57% TIO; 58% PBO).ConclusionThe LABA/LAMA combination of QVA149 once daily provided significantly superior, rapid and sustained bronchodilation vs PBO, IND, NVA and TIO, with significant symptomatic improvements and a safety profile similar to PBO.