RT Journal Article
SR Electronic
T1 QVA149 provides superior peak lung function in patients with COPD
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P3634
VO 42
IS Suppl 57
A1 Neil Barnes
A1 Shu Hashimoto
A1 Takahide Nagase
A1 Hungta Chen
A1 Nicola Gallagher
A1 Peter D'Andrea
A1 Vijay Alagappan
A1 Donald Banerji
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/P3634.abstract
AB IntroductionPeak FEV1 represents an objective endpoint to assess the effectiveness of bronchodilation in the morning when COPD symptoms are worst. Here we present peak FEV1 results from the QVA149 SHINE and ILLUMINATE trials.MethodsBoth studies randomized patients (pts) ≥40 yrs with moderate-to-severe COPD to: QVA149 110/50μg, indacaterol (IND) 150μg, glycopyrronium (GLY) 50μg, placebo (PB; all via the Breezhaler® device) or open-label tiotropium (TIO), 18μg; via the Handihaler® device) (2:2:2:1:2) in the SHINE study; and QVA149 110/50µg or salmeterol/fluticasone (SFC) 50/500µg (via the Accuhaler® device) (1:1) in the ILLUMINATE study.ResultsThe SHINE and ILLUMINATE studies randomized 2144 pts (89.1% completed) and 523 (82.6% completed), respectively. Least squares mean (LSM) difference for peak FEV1 was statistically significant and clinically relevant for QVA149 vs. SFC on Day 1, Wk 12 and 26 (Table). QVA149 showed a statistically significant improvement vs. PB, IND, GLY and TIO for peak FEV1 at Day 1, Wk 12 and 26 (Table).View this table:Table: Peak FEV1 (0-4h post-dose)ConclusionOnce-daily QVA149 provided sustained, superior and clinically relevant improvements in peak FEV1 and vs. IND, GLY, TIO, SFC and PB.