SESSION TITLE: COPD QVA149 Posters
SESSION TYPE: Poster Presentations
PRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PM
PURPOSE: Dyspnea, 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 and tiotropium for improvement in direct patient-reported dyspnea as assessed by the innovative self-administered computerized baseline and transition dyspnea index (SAC-BDI/TDI).
METHODS: This multicenter, blinded, placebo-controlled, 3-period, crossover study, patients aged ≥40 years with moderate-to-severe COPD were randomized to once-daily QVA149 110/50 µg, placebo or tiotropium 18 µg. Improvements were assessed by the total SAC-TDI score after 6 weeks.
RESULTS: 247 patients (mean age 62.8 years; 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 tiotropium (p=0.021). Least squares mean treatment differences between QVA-placebo, QVA149-tiotropium and tiotropium-placebo 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 (QVA 34.7%, tiotropium 24.9%, placebo 18.1%) compared to placebo (odds ratio [OR] 2.65; p<0.001) and tiotropium (OR 1.66; p=0.037). The percentage of patients showing any adverse event with QVA149 (35.0%) was similar to tiotropium (35.5%) and slightly lower than placebo (39.4%).
CONCLUSIONS: In the BLAZE study, QVA149 provided statistically superior improvements in patient reported breathlessness compared to placebo and standard of care tiotropium.
CLINICAL IMPLICATIONS: LABA/LAMA dual bronchodilation with QVA149 has the potential to be a better choice of treatment for controlling breathlessness in the management of COPD.
DISCLOSURE: Anthony D'Urzo: Consultant fee, speaker bureau, advisory committee, etc.: Novartis, AstraZeneca, Forest Laboratories, Pfizer, Schering Plough, Grant monies (from industry related sources): GSK, Schering Plough, Methapharma, AstraZeneca, Merck Canada, Forest Laboratories, Novartis Donald Mahler: Consultant fee, speaker bureau, advisory committee, etc.: consultant for GlaxoSmithKline, Novartis, and Sunovion, and have served on Advisory Boards for Boehringer Ingelheim, GlaxoSmithKline, Novartis, Pearl, and Sunovion, Grant monies (from industry related sources): receiving grants for clinical trials from Boehringer Ingelheim, Novartis, and Sunovion Tracy White: Employee: Novartis Pharmaceuticals Corporation Vijay Alagappan: Employee: Novartis Pharmaceuticals Corporation Hungta Chen: Employee: Novartis Pharmaceuticals Corporation Karoly Kulich: Employee: Novartis Pharma AG Nicola Gallagher: Employee: Novartis Horsham Research Centre Donald Banerji: Employee: Novartis Pharmaceuticals Corporation The following authors have nothing to disclose: Heinrich Worth
Clinical trial results of QVA149, combination of two approved products indacaterol and glycopyrronium, will be presented, QVA149 is in the late stage phase 3 trials prior to approval.