Back to Journals » International Journal of Chronic Obstructive Pulmonary Disease » Volume 9 » Issue 1

Efficacy and safety of coadministration of once-daily indacaterol and glycopyrronium versus indacaterol alone in COPD patients: the GLOW6 study

Authors Vincken W, Aumann J, Chen H, Henley M, McBryan D, Goyal P

Received 16 July 2013

Accepted for publication 16 October 2013

Published 24 February 2014 Volume 2014:9(1) Pages 215—228

DOI https://doi.org/10.2147/COPD.S51592

Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 4

Walter Vincken,1 Joseph Aumann,2 Hungta Chen,3 Michelle Henley,3 Danny McBryan,4 Pankaj Goyal4

1Respiratory Division, University Hospital, UZ Brussel, Free University of Brussels, Brussels, Belgium; 2Longartsenpraktijk, Prins Bisschopssingel, Hasselt, Belgium; 3Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA; 4Novartis Pharma AG, Basel, Switzerland

Background: Addition of a second bronchodilator from a different pharmacological class may benefit patients with moderate-to-severe chronic obstructive pulmonary disease (COPD) whose symptoms are insufficiently controlled by bronchodilator monotherapy. GLOW6 evaluated the efficacy and safety of once-daily coadministration of the long-acting β2-agonist indacaterol (IND) and the long-acting muscarinic antagonist glycopyrronium (GLY) versus IND alone in patients with moderate-to-severe COPD.
Materials and methods: In this randomized, double-blind, parallel group, placebo-controlled, 12-week study, patients were randomized 1:1 to IND 150 µg and GLY 50 µg daily (IND + GLY) or IND 150 µg daily and placebo (IND + PBO) (all delivered via separate Breezhaler® devices). The primary objective was to demonstrate the superiority of IND + GLY versus IND + PBO for trough forced expiratory volume in 1 second (FEV1) at week 12. Other end points included trough FEV1 at day 1, FEV1 area under the curve from 30 minutes to 4 hours (AUC30min–4h), peak FEV1, inspiratory capacity and trough forced vital capacity (FVC) at day 1 and week 12, and transition dyspnea index (TDI) focal score, COPD symptoms, and rescue medication use over 12 weeks.
Results: A total of 449 patients were randomized (IND + GLY, 226; IND + PBO, 223); 94% completed the study. On day 1 and at week 12, IND + GLY significantly improved trough FEV1 versus IND + PBO, with treatment differences of 74 mL (95% CI 46–101 mL) and 64 mL (95% CI 28–99 mL), respectively (both P<0.001). IND + GLY significantly improved postdose peak FEV1, FEV1 AUC30min–4h, and trough FVC at day 1 and week 12 versus IND + PBO (all P<0.01). TDI focal score and COPD symptoms (percentage of days able to perform usual daily activities and change from baseline in mean daytime respiratory score) were significantly improved with IND + GLY versus IND + PBO (P<0.05). The incidence of adverse events was similar for the two treatment groups.
Conclusion: In patients with moderate-to-severe COPD, once-daily coadministration of IND and GLY provides significant and sustained improvement in bronchodilation versus IND alone from day 1, with significant improvements in patient-centered outcomes.

Keywords: indacaterol, glycopyrronium, inhalation therapy, bronchodilation, COPD, Breezhaler®

Creative Commons License 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.

Download Article [PDF]  View Full Text [HTML][Machine readable]

 

Readers of this article also read:

LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD

Zhong N, Wang C, Zhou X, Zhang N, Humphries M, Wang L, Thach C, Patalano F, Banerji D

International Journal of Chronic Obstructive Pulmonary Disease 2015, 10:1015-1026

Published Date: 5 June 2015

Proliferation and stemness preservation of human adipose-derived stem cells by surface-modified in situ TiO2 nanofibrous surfaces

Tan AW, Tay L, Chua KH, Ahmad R, Ali Akbar S, Pingguan-Murphy B

International Journal of Nanomedicine 2014, 9:5389-5401

Published Date: 21 November 2014

Central airways remodeling in COPD patients

Pini L, Pinelli V, Modina D, Bezzi M, Tiberio L, Tantucci C

International Journal of Chronic Obstructive Pulmonary Disease 2014, 9:927-933

Published Date: 1 September 2014

Functionalization of ethylene vinyl acetate with antimicrobial chlorhexidine hexametaphosphate nanoparticles

Wood NJ, Maddocks SE, Grady HJ, Collins AM, Barbour ME

International Journal of Nanomedicine 2014, 9:4145-4152

Published Date: 27 August 2014

Effect of high-dose N-acetylcysteine on airway geometry, inflammation, and oxidative stress in COPD patients

De Backer J, Vos W, Van Holsbeke C, Vinchurkar S, Claes R, Parizel PM, De Backer W

International Journal of Chronic Obstructive Pulmonary Disease 2013, 8:569-579

Published Date: 22 November 2013