• Eric Bateman, Nicola Gallagher, Donald Banerji, and Kenneth Chapman.
• Chest. 2014 Mar 1;145(3 Suppl):401A.

Session TitleCOPD QVA149 PostersSESSION TYPE: Poster PresentationsPRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PMPURPOSE: The current GOLD strategy recommends combining two long-acting bronchodilators for the maintenance treatment of patients with moderate-to-severe COPD. The SHINE study evaluated the effect of QVA149, a dual bronchodilator combining the LABA indacaterol and the LAMA glycopyrronium (NVA237), compared with glycopyrronium, indacaterol, tiotropium monotherapies and placebo.MethodsIn this 26-week, multicenter, double-blind, parallel-group, placebo and active controlled (open-label tiotropium) study, patients ≥40 years with moderate-to-severe COPD (post-bronchodilator FEV1/FVC <0.7 and FEV1 ≥30% to <80% predicted) and smoking history ≥10 pack-years were randomized to receive once-daily QVA149 (110/50µg), indacaterol (150µg), glycopyrronium (50µg), tiotropium (18μg) or placebo (2:2:2:2:1). Here, we present the improvements in lung function, Transition Dyspnea Index (TDI) and St. George's Respiratory Questionnaire (SGRQ) total score by COPD disease severity and prior medication use.ResultsIn total, 2144 patients (mean age 63.9 years; mean FEV1 post-bronchodilator 55.2% predicted) were randomized (QVA149 [n=475]; indacaterol [n=477]; glycopyrronium [n=475]; tiotropium [n=483]; placebo [n=234]); 89.1% completed the study. Significant improvements in lung function, dyspnea and health status were observed with QVA149 compared to placebo with a treatment difference of 370 mL and 260 mL in FEV1 AUC5min-4h, 240 and 120 mL in trough FEV1, 1.17 and 1.00 in TDI and -2.74 and -3.77 in SGRQ score, in patients with moderate and severe COPD, respectively. Compared with placebo, QVA149 demonstrated a significant improvement in lung function, dyspnea and health status with a treatment difference ranging from 300 to 370 mL for FEV1 AUC5min-4h and 170 to 250 mL for trough FEV1, 0.71 to 2.27 in TDI and -0.34 to -5.94 in SRGQ total score, respectively in all the subgroups of patients with different prior medications.ConclusionsWith once-daily QVA149, similar improvements were seen in both moderate and severe COPD patients independent of medications used prior to recruitment and randomization into the SHINE study.Clinical ImplicationsThe SHINE study showed that once-daily QVA149 improves lung function, dyspnea and health status regardless of COPD disease severity and prior medications use.DisclosureKenneth Chapman: Consultant fee, speaker bureau, advisory committee, etc.: "KRC holds the GSK-CIHR Research Chair in Respiratory Healthcare Delivery at the University Health Network, has served as a consultant to CSL Behring, GlaxoSmithKline, Novartis, Nycomed (Takeda), and Talecris (Grifols), and has received payment for lectures or service on speakers bureaus from Boehringer-Ingelheim, GlaxoSmithKline, Grifols, Nycomed (Takeda), Family Physicians Airways Group of Canada, Canadian Network for Respiratory Care, and Talecris. " Eric Bateman: Consultant fee, speaker bureau, advisory committee, etc.: Prof Eric Bateman has served on advisory boards for Boehringer Ingelheim, AstraZeneca, Elevation Pharma, Napp Pharma, Novartis, Almirall, Forest, and Merck and Takeda; has served as a consultant to Navigant Consulting, IMS consulting group, ALK-Abello, Almirall, Hoffman la Roche, and ICON; has been paid lecture fees by AstraZeneca, ALK-Abello, Chiesi, Boehringer Ingelheim, GlaxoSmithKline, Nycomed/Takeda, Novartis, Pfizer, and Indegene Lifesciences Ltd. Nicola Gallagher: Employee: Novartis employee Huilin Hu: Employee: Novartis employee Donald Banerji: Employee: Novartis employeeClinical 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.

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