Back to Journals » International Journal of Chronic Obstructive Pulmonary Disease » Volume 8

Efficacy and safety of QVA149 compared to the concurrent administration of its monocomponents indacaterol and glycopyrronium: the BEACON study

Authors Dahl R, Jadayel D, Alagappan V, Chen H, Banerji D

Received 8 June 2013

Accepted for publication 13 August 2013

Published 17 October 2013 Volume 2013:8 Pages 501—508

DOI https://doi.org/10.2147/COPD.S49615

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 5



Ronald Dahl,1 Dalal Jadayel,2 Vijay KT Alagappan,3 Hungta Chen,3 Donald Banerji3

1Department of Dermatology, Allergy Centre, Odense University Hospital, Odense, Denmark; 2Novartis Horsham Research Centre, Horsham, UK; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA


Introduction: The BEACON study evaluated the efficacy and safety of QVA149, 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), in development for the treatment of patients with chronic obstructive pulmonary disease (COPD), compared with the free-dose concurrent administration of indacaterol plus glycopyrronium (IND+GLY).
Methods: In this multicenter, double-blind, parallel group study, patients with stage II or stage III COPD (Global initiative for chronic Obstructive Lung Disease [GOLD] 2010) were randomized (1:1) to once-daily QVA149 (110 µg indacaterol/50 µg glycopyrronium) or concurrent administration of indacaterol (150 µg) and glycopyrronium (50 µg) via the Breezhaler® device (Novartis AG, Basel, Switzerland) for 4 weeks. The primary endpoint was to evaluate the noninferiority of QVA149 as compared with concurrent administration of IND+GLY, for trough forced expiratory volume in 1 second (FEV1) after 4 weeks of treatment. The other assessments included FEV1 area under the curve from 0 to 4 hours (AUC0–4 hours) at day 1 and week 4, symptom scores, rescue medication use, safety, and tolerability over the 4-week study period.
Results: Of 193 patients randomized, 187 (96.9%) completed the study. Trough FEV1 at week 4 for QVA149 and IND+GLY was 1.46 L ± 0.02 and 1.46 L ± 0.18, respectively. The FEV1 AUC0–4 hours at day 1 and week 4 were similar between the two treatment groups. Both treatment groups had a similar reduction in symptom scores and rescue medication use for the 4-week treatment period. Overall, 25.6% of patients in QVA149 group and 25.2% in the IND+GLY group experienced an adverse event, with the majority being mild-to-moderate in severity. No deaths were reported during the study or during the 30 days follow-up period.
Conclusion: The BEACON study demonstrated that once-daily QVA149 provides an efficacy and safety profile similar to the concurrent administration of its monocomponents indacaterol and glycopyrronium.

Keywords: COPD, LABA, LAMA, FEV1 AUC0–4 hours, rescue medication

Corrigendum for this paper has been published

Creative Commons License © 2013 The Author(s). This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution - Non Commercial (unported, v3.0) License. By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms.