SESSION TITLE: COPD QVA149 Posters
SESSION TYPE: Poster Presentations
PRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PM
PURPOSE: QVA149 is a once-daily dual bronchodilator containing a fixed-dose combination of the long-acting β2-agonist (LABA) indacaterol and long-acting muscarinic antagonist (LAMA) glycopyrronium (NVA237), for the treatment of chronic obstructive pulmonary disease (COPD). The BEACON study evaluated the efficacy and safety of QVA149 compared with the concurrent administration of indacaterol and glycopyrronium (IND+GLY).
METHODS: This multicenter, double-blind, parallel group, active controlled study randomized (1:1) patients with moderate-to-severe COPD to once-daily QVA149 (110 µg indacaterol/50 µg glycopyrronium) and placebo or concurrent administration of indacaterol (150 µg) and glycopyrronium (50 µg) via the Breezhaler® device for 4 weeks. The primary objective was to demonstrate the non-inferiority of QVA149 versus IND+GLY, for trough forced expiratory volume in one second (FEV1) after 4 weeks (non-inferiority margin = -100mL). Secondary objectives included FEV1 area under the curve from 0 to 4 hours (AUC0-4h) at Day 1 and Week 4, symptom scores, rescue medication use, safety and tolerability.
RESULTS: Of the 193 randomized patients, 187 (96.9%) completed the study. QVA149 demonstrated non-inferiority versus IND+GLY for trough FEV1 at Week 4 (treatment difference= -0.005L (95% Confidence interval (CI): -0.051, 0.040). The treatment differences for FEV1 AUC0-4h between QVA149 and IND+GLY at Day 1 and Week 4 were 0.02L (95%CI: -0.005, 0.054) and -0.01L (95% CI: -0.059, 0.034), respectively. Both treatment groups had a similar reduction in symptom scores and recuse medication use from baseline. The incidence of adverse events was similar between QVA149 (25.6%) and the IND+GLY (25.2%) groups. No deaths were reported in the study.
CONCLUSIONS: Once-daily QVA149 improved lung function, reduced symptom scores and rescue medication use, and had a similar safety and tolerability profile compared with the free combination of its mono-components.
CLINICAL IMPLICATIONS: The study demonstrated that QVA149 provides benefits of dual bronchodilation in a single inhaler device, making it a more convenient treatment option for patients with moderate-to-severe COPD
DISCLOSURE: Ronald Dahl: Consultant fee, speaker bureau, advisory committee, etc.: In the past 3 years, Professor Dahl has received compensation for consulting with Boehringer-Ingelheim, Novartis, Vectura, Roche, Elevation Pharma and Norpharma; has undertaken research funded by AstraZeneca, Boehringer- Ingelheim, C hiesi, GlaxoSmithKline, Novartis, ALK-Abello and Stallergenes; has participated in educational activities sponsored by AstraZeneca, Boehringer-Ingelheim, GlaxoSmithKline, ALK-Abello, Novartis, Almirall. Dalal Jadayel: Employee: Novartis Employee Vijay Alagappan: Employee: Novartis Employee Hungta Chen: Employee: Novartis Employee Donald Banerji: Employee: Novartis Employee
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.