RT Journal Article
SR Electronic
T1 Once-daily QVA149 demonstrates superior improvements in patient-reported dyspnea compared to tiotropium in patients with moderate-to-severe COPD: The BLAZE study
JF European Respiratory Journal
JO Eur Respir J
FD European Respiratory Society
SP P3635
VO 42
IS Suppl 57
A1 Mahler, Donald A.
A1 Decramer, Marc
A1 D'Urzo, Anthony
A1 Worth, Heinrich
A1 White, Tracy
A1 Alagappan, Vijay
A1 Chen, Hungta
A1 Kulich, Karoly
A1 Gallagher, Nicola
A1 Banerji, Donald
YR 2013
UL http://erj.ersjournals.com/content/42/Suppl_57/P3635.abstract
AB IntroductionDyspnea, the most distressing symptom experienced by COPD patients, is not always adequately relieved by bronchodilator monotherapy. The BLAZE study evaluated the superiority of QVA149, a dual bronchodilator combining the long-acting β2-agonist indacaterol and the long-acting muscarinic antagonist glycopyrronium, versus placebo (PB) and tiotropium (TIO) for improvement in direct patient-reported dyspnea as assessed by the innovative self-administered computerized baseline and transition dyspnea index (SAC-BDI/TDI).MethodIn this multicenter, blinded, placebo-controlled, 3-period, crossover study, patients ≥40yrs were randomized to once-daily QVA149 110/50µg, TIO 18µg, or PB. Improvements were assessed by the total TDI score after 6wks.Results247 patients (mean age 62.8yrs; FEV1 post-bronchodilator 56.1% predicted) were randomized; 77.3% completed the study. Patient-reported SAC-TDI total score was significantly improved with QVA149 compared to PB (p<0.001) and TIO (p=0.021). Least squares mean treatment differences between QVA-PB, QVA149-TIO and TIO-PB were 1.37, 0.49 and 0.88, respectively. The percentage of patients achieving ≥1 point improvement in SAC-TDI score was significantly higher with QVA149 (QVA149 34.7%, TIO 24.9%, PB 18.1%) compared to PB (odds ratio [OR] 2.65; p<0.001) and TIO (OR 1.66; p=0.037). The percentage of patients showing any adverse event with QVA149 (35.0%) was similar to TIO (35.5%) and slightly lower than PB (39.4%).ConclusionDual bronchodilation with QVA149 provided statistically superior improvements in patient reported breathlessness compared to tiotropium and placebo.