Obstructive Lung Diseases |

Once-Daily QVA149 Improves Lung Function, Dyspnea, and Health Status Independent of Disease Severity and Prior Medications: The SHINE Study FREE TO VIEW

Kenneth Chapman, MD; Eric Bateman, MD; Nicola Gallagher, PhD; Huilin Hu, PhD; Donald Banerji, MD
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Asthma and Airway Centre, University Health Network, Toronto Western Hospital, Toronto, ON, Canada

Chest. 2014;145(3_MeetingAbstracts):401A. doi:10.1378/chest.1813585
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SESSION TYPE: Poster Presentations

PRESENTED ON: Saturday, March 22, 2014 at 01:15 PM - 02:15 PM

PURPOSE: 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.

METHODS: In 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.

RESULTS: In 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.

CONCLUSIONS: With 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 IMPLICATIONS: The SHINE study showed that once-daily QVA149 improves lung function, dyspnea and health status regardless of COPD disease severity and prior medications use.

DISCLOSURE: Kenneth 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 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




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